User talk:Davidtfull/Archive 1

Declaration of possible COI or introduction of inadvertent bias
I am new to Wikipedia, so this is my first entry as a new user. I am the director of the Fluoroquinolone Toxicity Research Foundation and I have joined Wikipedia in an effort to assure that the articles being written concerning the fluoroquinolones and their horrendous adverse reactions are factual in nature and well as the proper citations included in such entries. I have reviewed the COI (conflict of interest) policy of Wikipedia and will make every effort to assure that my contributions do not violate this policy. I have revealed this possible COI to the various editors who have worked, or are working on the fluoroquinolone articles and they did not raise any objections (thus far) regarding my participating in editing these articles.

I am recognized as an expert regarding the fluoroquinolone class as well as their associated adverse drug reactions, and will do my very best to restrict my contributions to this knowledge base. Should any of my contributions reveal an inherent bias, though certainly inadvertent on my part, or in any way violate the COI restrictions, I encourage any editor to please bring this to my attention so that such bias or COI can be eliminated from the articles.

Though I am an advocate for the victims of these reactions, I agree with Wikipedia's policy that Wikipedia is NOT the place to promote such advocacy. As there are so few people with any expert knowledge concerning this subject I believe my contributions would be invaluable. As I am only human, there will be occasions where such COI or bias may escape my notice while making such contributions, and I STRONGLY ENCOURAGE anyone who believes that I have made such an inadvertent error to please bring this to my attention immediately together with suggestions to resolve such conflicts. It is NOT my intention to misuse or abuse the hospitality of Wikipedia with my efforts to present well-researched and factual documentation regarding these drugs.

I am currently working on the stub entries for the fluoroquinolone toxicity syndrome pages, as well as updating the current pages for the fluoroquinolone drugs and would appreciate any help or input from the various experienced editors here regarding my efforts. There is a LOT to learn regarding the proper use of Wikipedia and I am sure that I will make, or have made, a tremendous amount of honest mistakes. So any and all guidance would certainly be appreciated to reduce the amount of inadvertent screws-up I will surely be making in the days to come. Davidtfull (talk) 05:29, 8 February 2009 (UTC)

About the Fluoroquinolone Toxicity Research Foundation
In an effort to provide full disclosure, I thought it best to explain exactly what the Foundation is and my relationship to it:

The Foundation is an Internet community consisting of patients from all over the world who have suffered a severe adverse drug reaction to the drugs found within the fluoroquinolone class. First coming into existence in 2001, following my own adverse reactions that left me blinded (permanent double vision) as well as crippled (chronic tendinitis) together with multiple serious and life-threatening medical problems. As one of original members of the quinolone adverse drug reaction forum, I started researching these reactions in hopes of finding a cure for my own medical conditions. Soon I found numerous journal entries that described these reactions and I, as well as other members who were doing the same, started posting these articles on the forum. The next thing you knew, we had hundreds of such articles. But accessing them became a major pain as they resided in the archives.

Striking out on my own I created the non-profit association known as the Fluoroquinolone Toxicity Research Foundation to act as the caretaker of these articles. I developed a website (fqresearch.org) to act as a repository for these articles as well as a forum (Fqtoxicity hosted by Yahoo) to allow contributors to discuss these articles. In accordance with Title 17 U.S.C. Section 107 all material found within fqresearch.org is being distributed without profit to those who have expressed a prior interest in receiving this information for research and educational purposes. The material presented on fqresearch.org may not be used for any other purpose other than that which is stated above. Any Author or copyright holder who had any objections to this material being presented in this fashion was afforded an opportunity to have such articles removed. To date no such objections have been received and no articles have been removed. Currently there are well over 4000 such articles, clinical studies, case reports, etc., available to those who have an interest.

Having read each and every one of these documents I have gained a tremendous amount of knowledge concerning the fluoroquinolones. And the more I read the more convinced I was that what had happen to me and millions of other such victims was completely avoidable. I also found that the ignorance within the medical community regarding this class to be appalling. I began networking with various other forums around the world and developed a worldwide network that is dedicated to the continuous research of this class. As such the documentation has grown over the years beyond the point of reasonable management.

Over the years we have lobbied the FDA, various government officials, the various manufacturers, and anybody who we felt could help achieve the goal of providing fair disclosure regarding the true safety profile of this class; relentlessly. I have filed numerous petitions with the FDA, written and published hundreds of articles and editorials, and have become an expert on these drugs as well as a well-known and respected researcher and patient advocate. As a direct result of my efforts we see the recent addition of the Black Box Warnings concerning spontaneous tendon ruptures. The research I have accumulated had been forwarded to Public Citizen as well as the Attorney General of the State of Illinois. The Foundation is mentioned in a number of published medical journal articles as being both a reliable and factual source of information regarding this class.

Currently the Foundation has over 160 active members worldwide and has counseled tens of thousands of patients regarding their adverse reactions. Our advocacy is not of a radical nature, but one of knowledge. It is our goal that the patient, as well as the treating physician, is provided with sufficient factual documentation regarding the safety profile of this class to be able to enter into a reasonable risk-benefit discussion. It is also our goal that the package inserts for this class clearly and precisely communicate this risk. Whether it is the removal of the false and misleading information currently to be found there, or the addition of Black Box Warnings.

The Foundation fully understands that any drug has the potential of severe adverse reactions. We do not advocate the removal of this class from clinical use unless the proven safety profile justifies such drastic action. What we do advocate, however, is full disclosure on the part of the manufacturers, together with just compensation for those who have been crippled for life as the direct result of withholding such crucial information from the physician as well as the patient.

The foundation is dedicated to presenting the research regarding these issues in the hope of preventing such injury to others and to make such research readily available to those who have shown a prior interest. We strive to present accurate and up-to-date information to the victims of such scripting abuse so that they may be in a position to receive the medical care such rampant ignorance has denied them.

We also advocate additional research as to the manner in which such reactions manifest together with the development of treatment protocols. We support the use of "Dear Doctor" letters as well as "Black Box" warnings to further educate the patient and the physician regarding the very real risk of such reactions. The Foundation is not associated with any organization, special interest group, law firm or lobbyist. The Foundation is totally independent of any and all such influences. Nor is the Foundation associated with any other forums or websites found on the Internet that deals with this subject matter. The Foundation neither encourages financial donations, nor accepts any such contributions. The Foundation is fully funded by my own personal funds and has NEVER accepted any donation of any kind, from any person or corporation. The Foundation does NOT allow any advertising on its webpages nor any postings on its forum for the personal gain of any member.

We recognize the fact that the fluoroquinolones are a necessary tool to be found within the physician's arsenal, but we do not support the careless manner in which they are used today. Nor do we support the lack of disclosure and the false and misleading information currently found within the package inserts. Our advocacy is based upon correcting these gross errors while working within the system to educate both the patient and the treating physician. Nothing more and nothing less.

I own the Foundation outright and personally serve as the Director of the Foundation, I provide all the funds necessary regarding its activities out of my own pocket, as well as moderate the fqtoxicity forum hosted by Yahoo. I am advised by a council consisting of both lay people and professionals, but as they say "the buck stops here", and I take full responsibility for any and all action taken by the Foundation. Anyone who wishes further information is invited to contact me personally via my private email address -- which will be provided to those who leave such a request on this talk page -- (together with their email address so that I can provide this to them privately). Davidtfull (talk) 06:38, 8 February 2009 (UTC)

Welcome!
Welcome to Wikipedia, Davidtfull! I have been editing Wikipedia for quite some time. I just wanted to say hi and welcome you to Wikipedia! If you have any questions, feel free to leave me a message on or by typing helpme at the bottom of this page. I love to help new users, so don't be afraid to leave a message! I hope you like the place and decide to stay. Here are some pages that you might find helpful: I hope you enjoy editing here and being a Wikipedian! Oh yeah, I almost forgot, when you post on talk pages you should sign your name on talk pages using four tildes ( ~ ); that should automatically produce your username and the date after your post. If you need help, check out Questions, ask me on, or place helpme on your talk page and ask your question there. Again, welcome! NAHID 15:53, 24 January 2009 (UTC)
 * Introduction
 * The five pillars of Wikipedia
 * How to edit a page
 * Help pages
 * How to write a great article
 * Manual of Style

Thank you for your welcome NAHID. I do try to remember to sign anything I add but at times I screw up. There is a lot to learn here regarding the proper use of Wikipedia editing, so please bear with me as I stumble along here. But I do have one question: If I wish to discuss things with an individual, how do I go about doing this? Do I post something on their talk page, my talk page, or post the questions I have within the discussion page for the entries I am working on? Or do you contact the individual via their email? Any clarification would be appreciated. Davidtfull (talk) 04:27, 26 January 2009 (UTC)

Hello David. To answer your question, you can either try contacting an editor via their talk page or the community via the article talk page or sometimes both. I just want to bring to your attention Wikipedia's guide on article size Article_length. The article is currently 80 KB. Very few articles are above 100 KB. The main reason for this is because the majority of readers will not read articles above a certain size unless they are extremely interested in the subject matter. The size of the article is currently 80 KB. We may need to start refining the article soon. If you are very enthusiastic about editing the fluoroquinolone articles you could start editing if or when you have the time the individual fluoroquinolone articles and when you have created a side effect section you can add a "see also" link like in the main Quinolone article to it to direct people to the fluoroquinolone toxicity syndrome article if the reader is looking more detailed information on fluoroquinolone toxicity and adverse reactions. I think the fluoroquinolone toxicity article is the fastest developed article that I have seen. More work can be done to it I feel to improve it still. I have been trying to improve the ref format of the article as you probably noticed. You have done an incredible amount of work. Thank you for your contributions to Wikipedia. I have added your talk page to my watch list so you can reply here. -- Literature geek |  T@1k?  08:46, 29 January 2009 (UTC)

Replied on your talk page but will reply again here. The reason for the article coming together so quick is the fact that I have been researching and writing about this subject for over a decade now. What you see so far is but the tip of the iceberg. The article contains less than 75% of the known serious reactions. Not too sure how to handle the size limitations. But I think we have to limit this to the major reactions. But the problem being is that most of these are major reactions. :) Classic Catch-22. I will spend some time thinking about this and see what I can come up with. For the moment, let's just leave it as is and I will not add any more stubs until I work out a plan to comply with this limit. I may have to delete several of these stubs to make room for those that have a major impact on the patients quality of life without trying to explain the mechanisms of action as I have done so far with the previous stubs. It may end up being nothing more than a list of reactions should we do that though. Not much better than the package inserts. Davidtfull (talk) 09:07, 29 January 2009 (UTC)

New messages
I have left a message here, Talk:Fluoroquinolone_toxicity_syndrome for you and also on my talk page. No rush replying. -- Literature geek |  T@1k?  15:05, 5 February 2009 (UTC)

Guidance
Dear David,

I am BRAND new to Wiki, so please forgive me is I miss any protocol.

The reason that I am writing is because I have Quinolone Toxicity Syndrome and appreciate the work that you have been doing on it.

However, I was wondering if you could point me in the direction of a professional who understand this issue that could give me some help. The few doctors I've talked to about this in Colorado Springs have been of no help. Even a "lay person" with good knowledge of this would be helpful.

Anything you can do would be appreciated - thanks for your help and time.

All the best - Frank Manno Sermonator1 (talk) 08:35, 6 February 2009 (UTC) Frankmanno@msn.com

Levofloxacin
It would be great if you could revise the article on Levofloxacin too! - JamesLockson (talk) 14:20, 8 February 2009 (UTC)

Delayed Reactions
On the QTS page, I think we need a section on the delayed and worsening reactions of quinolones, as this is what makes it so unique from normal drug reactions. - JamesLockson (talk) 14:20, 8 February 2009 (UTC)

The page has been revised to include delayed reactions as well as skeletal injury. I think this is as far as we can go on that page, even though there is still a ton of stuff that should be added. We are rapidly approaching the 100 KB limit, which with a ton of judicial editing we may be able to be reduced to 80. But using such brevity will greatly reduce the impact of the stubs, rendering them no better than the package inserts. Talk about being caught between a rock and a hard place...typical Catch-22 here. - Davidtfull (talk) 23:42, 8 February 2009 (UTC)

Drug articles are a mess
Thanks for note on my talk page Drug control law, recently created by myself, may give a clearer idea of what I am trying to get at and to. Laurel Bush (talk) 12:23, 11 February 2009 (UTC)

Thank you
David, Feel free to revert or erase any of my edits. Just trying to help. Dbcipro (talk) 00:02, 17 February 2009 (UTC)

Talk page message
I've left a message here: Talk:Fluoroquinolone_toxicity_syndrome. --Steven Fruitsmaak (Reply) 15:13, 15 February 2009 (UTC)

Message from Literaturegeek
I have replied to your message from yesterday. Sorry for the delay I got distracted and then all of the other messages made me forget to reply to it. Here is the link to my reply. User_talk:Literaturegeek-- Literature geek |  T@1k?  00:39, 16 February 2009 (UTC)

Ciprofloxacin
Greetings! I'm re-posting my response to your inquiry here, as well as on my talk page. :-) Thanks for bringing this to my attention. Its not a brand name version of the drug, rather the name Ciprofloxacino is the name of the generic in Mexico. In selecting a photo, I tried to select one that didn't display any brand names or logos. The purpose of the photo was to show an example of the medication itself and its common packaging. Precedence exists, as there are similar photographs of medications and packaging in articles about other antibiotics such as Amoxicillin and even the common analgesic Acetaminophen. I reviewed the photo, and realized it wasn't clear from subtitle that Ciprofloxacino is the Spanish translation of Ciprofloxacin, and therefore have changed it. Does that help to address your concerns? I am open to further suggestions and discussion. --Nsaum75 (talk) 10:56, 16 February 2009 (UTC)

Do you have
Do you have any references, of any expert pharmacologists or doctors for example Dr. Flockhart or Dr Cohen where they say in publications, even a medical editorial or newspaper article on fluoroquinolone toxicity something along the lines of "serious concerns of toxic reactions" or "safety of fluoroquinolones is in doubt" or something like that? What about Ralph Nader's public citizen, have they ever made a statement like that in an official publication on their website? We really need something like that to quote to resolve neutrality issues as all the reviews seem to say mild to moderate safety profile. Ideally if you had such a citation, you could say in the article body after the mild to moderate cited claim, "however, this has been disputed by a leading expert in drug safety or this has been disputed by Public Citizen who advocate on consumer safety issues who stated that,,,,,." That way both claims are represented the review articles claim and claims by people on the other side of the fence are cited and challenging each other, that way the reader will know that there is controversy over their safety. I really would like both view points to be cited to resolve this neutrality rather than just the view point of the review articles who are reviewing largely data from drug company influenced or controlled clinical trials. Surely someone reliable somewhere has made some statements showing concern about the high rates of serious adverse reactions? I have your talk page on my watch list, so post any links you have here and quotes of people. The sooner we resolve this the better. -- Literature geek |  T@1k?  20:39, 18 February 2009 (UTC)

What about the evidence that Public Citizen submitted to the FDA? Did they not mention serious concerns in a publication which is online? Did they not petition and launch legal action? Anything an independent org or expert said? There must be something said somewhere with all the legal proceedings. Is there any evidence of lawsuits online, like a publication that we can cite. Something where their safety has been challenged. -- Literature geek |  T@1k?  20:48, 18 February 2009 (UTC)


 * I have literally four file cabinets full of such citations and challenges. Let me dig through that mess and present to you a list as well as the links to the original articles. To make life a little easier for you may I suggest that you log unto the fqresearch home page and toward the bottom to the left you will see a heading called "References". There you will find a list sorted by subject, of most of the citations found on the site. Each list is then sorted by date once you open it. You will find for example about 300 or so citations involving the tendon issues alone. Starting in 1962 and ending in 2008. Just click on the title and the list will open as word document. Feel free to save it on your own computer for future reference.


 * For the moment I am going to take a break from all the petty bickering and let things sort themselves out. As such just post here on my talk page rather than on the discussion page for the next few days or so. I'm finding Steve's attitude and arrogance bit overwhelming at the moment and would prefer to remain silent and let others think me a fool, rather than speak up and remove all doubt. Davidtfull (talk) 03:08, 19 February 2009 (UTC)

I see Steve has taken a break from Wikipedia. I think on the whole Steve's attitude was quite balanced in dealing with you. I am saddened that a productive editor has felt forced off Wikipedia due to drama and Steve was for the most part balanced in dealing with this dispute. I did try and tell you what happened when an editor tried to do what you did on the temazepam page and that you won't find anyone as balanced on wiki as me and Steve. I am pretty depressed myself about what has happened. There have been accusations that you created the sophia name as well as a sockpuppet in order to revert edits. If you did this I suggest you don't do this again, calm down your editing habits and become a productive editor. People shouldn't feel forced off Wikipedia. This is a free hobby people do for enjoyment. Once upon a time you thought quinolones were benign drugs, just because someone has that view doesn't make them the enemy to be destroyed. I recommend not comparing opposing views to holocaust denial either, it is doing no one any good. -- Literature geek |  T@1k?  22:22, 19 February 2009 (UTC)

I have not edited anything on the article since this whole dispute thing started. I have not used any alias or anything else. I have not talked to any other editors on the side encouraging them to edit anything either, or anything else of that nature. I sent a note to doc and asked him not to start editing away until some resolution was reached. I sent a note to Steve telling him I thought this whole thing was getting out of hand and asked him to review the research I had accumulated and if he felt that I did not have a leg to stand on I would bow out gracefully. I did not try to force anyone off. I volunteered to leave myself instead. If other people are screwing with this article it has nothing to do with me and I have NOT encouraged them to do so. My last comment on the talk page was that I agreed with Steve’s suggestion and thought it was reasonable solution. I had also stated that I would not be editing the article. So if any edits are taking place you will have to look elsewhere as I have nothing to do with them.

My last edit was adding the pharmacology sections to the levaquin article to comply with the style sheet. I have changed nothing on the toxicity article, other than cleaning up the citations that you had marked as missing since Steve's first edit. Just check the page history if you doubt this. If there is still drama going on I am not the cause of it, or a part of it. Davidtfull (talk) 01:27, 20 February 2009 (UTC)

Adverse effects of fluoroquinolones / Fluoroquinolone toxicity
I have split this topic into two co tracts and have asked for admin and WP:MED help. What was and is again current at Fluoroquinolone toxicity is supported by dozens of case studies and animal research. It uses this to make it sound like these side effects are common in human. This is misleading and I shall be continuing to address it at Adverse effects of fluoroquinolones which is the preferred terminology in the field of toxicology as per Goldfrank's. Cheers -- Doc James (talk · contribs · email) 11:14, 19 February 2009 (UTC)

As I told Literaturegeek, I'm withdrawn from this petty bickering about what terms to use for a while to let the dust settle. I had also declared a COI regarding any further editing of the article until some consensus is reached. Goldfrank's is indeed the respected authority on toxicology. But the actual experiences of the patient is trump.

As you can see, the entire issue is, as you stated "this to make it sound like these side effects are common... This is misleading". Granted, to state that for someone to experience this syndrome is common would indeed be both false and misleading, and even though I had never even supported such a view, I had gladly conceded this point months ago. But this is no more misleading than to state this syndrome presenting in a patient is to be considered "rare". That is just as, (and even more so), misleading and FALSE and what I have taken issue with. To flat-out deny the existence of this syndrome is to be considered gross malpractice. And those who subscribe to this draconian antiquated view have not conceded anything. There in lies what is actually at issue, and why it will never be resolved to anyone's complete satisfaction.

These drugs have a proven history of destroying a patient, both killing them and crippling them for life. The medical proofs of this are overwhelming and cannot be denied by any rational person. The medical community has a proven history of being in denial concerning this, lying to the patient telling them that such events are NOT even associated with these drugs and the various manufacturers have a proven track record of hiding the toxicities of their products from everybody concerned. As such nobody is right, when everybody is wrong.

So we will continue to argue about whose bias is to be determined not to be bias until the cows come home. OR we can compromise, accept what the patient has stated to have occurred, what the research supports and meet somewhere in the middle and try to present a fair and balanced article that gives a neutral heads-up to the physician, the patient, and the casual reader alike.

As for me, I intend to sit this one out until a consensus can be reached regarding what will be reported upon within by the article:
 * The health and welfare of the patient (I'm in)
 * The health and welfare of the drug manufacturers (I'm out)
 * The continuing of the status quo (I'm out)

So once you and the other powers-that-be make a decision regarding what view is going to be presented within the article, let me know so that we (the patients) can either help with the article or walk away. Choice is yours, so choose wisely. The quality of life of millions of patients is at stake here.

As such, all such inflated egos, stifling arrogances, and ignorances should be left off the table, and we should deal strictly with the facts. Either they support what is being stated or they do not. If they do not, then it does NOT belong in the article. If they do, they should NOT be excluded no matter how horrible they portray the drugs to be. A fact is a fact and no amount of Gestapo-like strong-arming to have them excluded from the article should be tolerated by anyone concerned.

If they are in dispute, then both sides should be presented with each side of the dispute given equal weight and equal time. But we have yet to reach this obvious conclusion. Until we do, I will remain on the bench as a spectator while you engage the others on the field of battle. As I had told Literaturegeek, my morals and ethics will not allow me to be associated with an article that advance a view that trivializes and minimizes these reactions. And I feel that the article as it stands, even though you considered it to be misleading, is anything but. Since you are the physician, and I am the patient whom your peers have destroyed with such an attitude, we have an insurmountable conflict of interest here. Any ideas as to how to go about resolving it instead of fighting about it? I'm more than willing to listen to reason if you do. Davidtfull (talk) 14:20, 19 February 2009 (UTC)


 * Patient POV do not trump anything. I quote percentages and they were removed. There is a concept in medicine called risk-benefit analysis. People die from infections, but outcomes occur with drugs. I agree completely that we should deal with is facts. And that is what I am doing. I understand if your COI keeps you from editing. Cheers. -- Doc James (talk · contribs · email) 20:22, 19 February 2009 (UTC)

I did not mention anything about POV. I had said "But the actual experiences of the patient is trump." I am well aware of what a risk-benefit analysis is. Certain number of people are going to react horribly to a drug. Certain number of people will have their lives saved. The analysis determines which side receives the most benefit. If more people will benefit than will be hurt the drug stays on the market. If more people will be hurt than benefit the drug comes of the market. It is a balancing act. For THIS reason I stated "the actual experiences of the patient is trump." One cannot conduct a fair risk-benefit assessment if all one considers is the benefits and discounts the harm. So to be fair one must LISTEN to the patient when they have a reaction and then determine if the drug was responsible. Not to bore you, but bear with me a moment (I may not the years correct here as my memory is shot to hell):

A thirty-year-old patient presents with pneumonia. (Late 1980s) NO significant medical history, no risk factors, nothing. A clean bill of health for the past thirty years other than minor head colds, etc. No surgeries, been in the hospital once to have his tonsils taken out. Prescribed a quinolone and has a mild heart attack and blows out his Achilles tendon. Doctor determines quinolone not responsible, but can find NO other cause.

About seven years later (mid-1990s), the patient is given Cipro for a head cold at a walk-in clinic. Ends up in ER on the verge of yet another heart attack, damage to the rotator cuff tendon, severe loss of muscle mass and strength, abnormal EKG, partial vision loss, severe gastro problems, brain fog, and his teeth go to hell just for starters. Told once again, even though he had given his previous medical history regarding the quinolones, that NO WAY do these drugs cause these kinds of problems. Took almost five years to achieve partial recovery.

In 1999 the patient went from 20/20 vision to needing glasses within a few months, developed an MINOR infection of the epididymis. Goes to the urologist who prescribes Cipro and a steroid dose pack. Patient goes to hell in a handbasket. Back into ER, chronic tendinitis, SEVERE gastro problems, manifest double vision, hurts from head to toe, develops a drug rash, and can barely even walk. Told to keep taking the meds, quinolones do NOT cause these symptoms. Develops a kidney stone from the Cipro and eight months later back to the urologist. Urologist prescribes first floxin, then Cipro and finally levaquin to treat the kidney stone. Told to take Motrin for the pain. Ends up in ER with severe seizures. Examined by the ER physician who, wait for this, prescribes yet a HIGHER dose of levaquin. Told that the three quinolone drugs he was on DO NOT CAUSE SEIZURES or TENDON ISSUES. Blew out both knees, both hips, developed tendonitis in his hand so severe that he cannot even bend his fingers. Bed ridden for a number of months. Developed permanent double vision, permanent tinnitus, peripheral neuropathy, swollen liver with cystic formations, cystic formations on his kidneys, pancreatitis, chronic tendonitis, severe yeast infections and canadias overgrowth, loses even more muscle mass, hair starts to fall out, his teeth literally break off while brushing his teeth (later exam showed complete calcification of all the nerves in the teeth) and on and on and on it went.

Sent to every "ologist" there is and NONE of these professional physicians would even ACKNOWLEDGE that the quinolones could possibly be to blame. But NO other etiology was ever found. Does this patient show up in any of your studies? No. Is he part of the risk-benefit analysis? Again no. The patient is now crippled for life and has suffered medically for almost three decades now. I am that patient.

You are indeed correct that my POV concerning this is meaningless. But my experiences are not. You may argue that I am the exception. I am arguing that I may be the rule. You point to your studies as your proofs and I point to the fact that physicians DENIED any association whatsoever in my case and continue to do so to this day. People such as I are NOT in your statistics. As such, your statistics have no value. You can prove anything with statistics depending upon what you leave in and what you leave out.

A lot of reviews are out-and-out fabrications applying the rule of exclusion. As I mentioned to Steve when he cited a review that stated discontinuation of these drugs within the clinical studies was less than 4%. A review of 6 clinical studies found within the NDA for Levaquin alone showed a greater than 9% discontinuation rate. Double of what this study had stated. Same rates are found within the other NDAs. Levaquin had a 40% ADR rate with associated fatalities within these studies. The package insert states this to be about 2%. The 60-day Cipro study showed an ADR rate of about 16.5% for Cipro. But this was AFTER they had excluded over half of those who reported an ADR. Out of over 340 reports of a severe ADR, only 7 patients' reports were included in the study. And on and on it goes, study after study, review after review. So I guess I am just sick and tired of being lied to. Is it asking too much that the physician and patient alike be told the truth for once?

Out of almost three hundred responses to a survey that had asked about the patient's experiences with the fluoroquinolones, 99% of those who responded stated "NO" to the following four questions:

Did your physician exhibit ANY prior knowledge concerning the adverse reactions associated with the fluoroquinolones? No.

Was your physician willing to admit that the drug could possibly be responsible? No.

Where you given any advice as to what side effects you may experience? No.

Did the physician enter into a risk-benefit discussion prior to prescribing the drug? No.

So if the person who determines whether or not the adverse event is to be associated with the study drug has NO knowledge concerning such events, what are the chances that such events will NOT be attributed to the study drug? Care to respond with a percentage?

Thanks for listening. I believe you may be the FIRST physician in a very long time. Cheers as well, and no sarcasm intended. :)

dave

On a side note, I am not arguing that these drugs do not save lives. Indeed they do, as well as a number of safer alternatives that do not cause such horrendous collateral damage. Just pisses me off to no end that such ignorance and arrogance destroyed mine. Needlessly. Which is why I am of the opinion that an article on the adverse events should not attempt to trivialize these risks and give the treating physician even more reason to deny the proven associations, and destroy even more lives needlessly. - Davidtfull (talk) 01:08, 20 February 2009 (UTC)

LOL, why did someone do a spelling fix on a talk page!?! How strange. -- Literature geek |  T@1k?  03:27, 23 February 2009 (UTC)


 * Note the vocabulary ("LOL") and tone (ridicule) of the above "contribution"... Not the only instance. -Whiner01 (talk) 04:26, 23 February 2009 (UTC)

Categorization of pharmacology articles
I have updated the most recent draft at WT:PHARM:CAT, and, if available, would appreciate your feedback. kilbad (talk) 12:49, 19 February 2009 (UTC)

For the moment I waiting to see where the toxicity article is headed before making any comments on other issues. Once that inferno settles down to a dull roar we will take it from there. But thanks for the invite. Davidtfull (talk) 13:19, 19 February 2009 (UTC)
 * Have things settled down enough for you to look at WT:PHARM:CAT? kilbad (talk) 00:59, 27 February 2009 (UTC)

Unfortunately they have not. Every time we get close to resolving all the issues someone mucks it all up and we have to start all over again. I did take a look at what you are proposing and nothing looked out of place. But I only did a guick take of it. When I get the quinolone article straightened out I will spend more time reviewing it and provide some feed back. Right now I would be not able to do it any justice. Far too much on my plate at the moment with this mess.Davidtfull (talk) 01:41, 3 March 2009 (UTC)


 * OK, got that article put to bed. I took a longer look at what you were working on with the Pharm Cat, reviewed the various comments made and must admit I don't have enough experience with that to be of much help.  I'm still struggling with learning how use wikipedia properly so I would be more of a hinderance than of any value at the moment commenting on something that intricate.Davidtfull (talk) 06:14, 21 March 2009 (UTC)

Re: From the desk of David Fuller
Dear David,

thanks for your message. You asked why I think you were ignorant; I never said you were and of course I don't think you are; you're just very very biased. I might be biased as well but I can assure you that I'm a very open-minded person, I have learned from this experience, and now every day when I treat patients with quinolones I think twice before giving them steroids, I check the renal function, I make sure they're not psychotic or not suffering from tendon problems etc. I have a special interest in geriatrics so I can assure you that I agree that it is not the first drug of choice in this population.

However, writing neutrally is actually very simple: That's what I did, but obviously you guys disagree. So we need to find a consensus where we can all agree, and I think the way to do that is to just say that the medical community thinks one thing based on most studies, but that there is evidence of underreporting and that there is a health advocacy movement against quinolones. That's just the way I see things.
 * 1) Forget everything you think you know, and leave all your prejudices (good and bad ones), behind you. Better yet, "write for the enemy" (see WP:NPOV)
 * 2) Find the most relevant sources with the highest quality that you can find.
 * 3) Read what they're saying and summaries it in your own words (literal reproduction is a copyright violation)

I don't really believe you when you talk about "tremendous work still needed to improve the article", because (1) I don't see anything going the right way, and (2) you and the other editor make a lot more edits than I did, and I really tried to write a good and balanced introduction. My version could easily have been tweaked by you guys who make dozens of edits each day, to make it more balanced.

Maybe you should read articles on other controversial topics to see how things are dealt with there. For example, you would expect that the article in NAMBLA explains how it is a bunch of delusional pedophiles who believe they are the victims. However, even they are treated with a neutral tone on Wikipedia. You shouldn't write like you are trying to sell your views to the reader: just keep a neutral tone and let the facts speak for themselves.

I have not attacked the article and I have not attacked you. I apologize if that's your perception. I'm not "going ballistic" either. I just think that most of your references are a classic case of using primary studies to debulk the conclusion of secondary sources which are reviews (see Reliable_sources_(medicine-related_articles)).

You correctly state that "The term "fluoroquinolone toxicity syndrome" has been in use since the late 'nineties by those who have suffered from this.". That is exactly what the article should be saying: that it is a term used by those who believe that, as your website states, these drugs bring catastrophe only. We don't use the term "myalgic encephalomyelitis" either although I assure you, there are millions of sufferers like you who would like us to do so. You should distinguish "facts" from "viewpoints".

Furthermore you say that I should leave the article if I don't agree but you should have noticed that I already have left. Editing that article is something for which I currently have no time and it would certainly not give me the pleasure I get from editing other articles.

And I think the only thing that will make me "lighten up" would be if you guys would be a bit more open-minded and reasonable too. Not like this for example. --Steven Fruitsmaak (Reply) 19:52, 19 February 2009 (UTC)


 * It was not I that suggested you leave, in fact it was my intention that I leave instead to restore peace, but LG persuaded me to stay for a while. Anyhow, the original text stated the orgin of this term which has been in use since 2000.  This explanation was deleted by others.  To further clarify things it is NOT a "term used by those who believe that, as your website states, these drugs bring catastrophe only.", it is a term used to describe the non-abating adverse reactions to the fluoroquinolone class of chemotherapuetic agents.  Nothing more, nothing less.  Additionally my website does NOT state what you had implied either.  My website states that we believe it to be a toxic and dangerous drug that should only be used as a last resort when there is no other viable option.  We have never challenged the efficacy of this class, nor the appropriate use either.  We have however challenged it's safety profile and the outrageous scripting abuse associated with it.  If the proofs we have provided on my website condemn it as a drug that "brings catastrophe only", keep in mind I did not write these proofs, your peers did and published them in the leading journals. I am just the libarian, not the various authors whose research we present.Davidtfull (talk) 01:17, 27 February 2009 (UTC)

What about this one
Hello, Do you have the full text of this one? Or other articles which are similar which report a high incidence of adverse effects? If you can track this one down that would be great.neuropsychiatric effects, fluoroquinolones pubmed -- Literature geek |  T@1k?  09:16, 20 February 2009 (UTC)
 * It is a pay to view article, here is the link:

http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6WP9-4DKKF2F-1&_user=10&_rdoc=1&_fmt=&_orig=search&_sort=d&view=c&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=91e54330c11e290fe00d7d87a983a092 I will see what I have already and forward them to you when I have the chance. I should have the full text in my files. If I do I will send you a copy. Davidtfull (talk) 00:46, 21 February 2009 (UTC)

We need more independent publications like this one. If you have them, send a link to them to my talk page or here please. Thanks. I am going to try and add some neutrality to the article. -- Literature geek |  T@1k?  09:17, 20 February 2009 (UTC)

Congrats on getting your name and website actually into a wiki article LOL. I haven't seen that happen before. You wouldn't get that in a package insert, so you achieved something on your days on Wikipedia. You left your mark, so to speak.

David T. Fuller is an outspoken critic of these drugs and has been collecting research on them for over 10 years. He is the Director of the Fluoroquinolone Toxicity Research Foundation as well as the Webmaster of FQresearch.org.[27] :--) -- Literature geek |  T@1k?  10:26, 20 February 2009 (UTC)


 * He has reference to him. And, by the sound of it, is a well-known critic, so I see no problems with including him. Doc James  (talk · contribs · email) 22:51, 20 February 2009 (UTC)


 * I have no idea what you two are talking about. Mind if someone clues me in on what this is about? Davidtfull (talk) 00:46, 21 February 2009 (UTC)

See this Adverse effects of fluoroquinolones. If there are any inaccuracies in that section let us know on the talk page so that they can be amended. -- Literature geek |  T@1k?  15:56, 21 February 2009 (UTC)

Something that would be useful to do. Do you have access to the brand and trade names of quinolones in English-speaking countries? If you do you could add them to the introduction/lead of all of the quinolones which are sold in English-speaking countries and bold them. That way people will find the quinolone in a Google search. Most wiki articles list common brand/trade names in the lead for this purpose. You could edit them in -- it is not a controversial edit. You can find the names here by searching for the generic in the medicines complete website. I think that you can register a free 15-day trial at that site as well. I think that there are only about 10 quinolones used in the western world, so it shouldn't take very long. Many people Google Cipro or Ciproxin (and whatever other names it is sold under in South Africa, Australia or wherever else) so will not come across wiki pages. -- Literature geek |  T@1k?  00:04, 22 February 2009 (UTC)

brand names
You can use this link to find the brand names for any drug:

http://www.drugbank.ca/drugs/DB01137

Levaquin:


 * 1. Cravit
 * 2. Cravit Ophthalmic
 * 3. Elequine
 * 4. Floxel
 * 5. Iquix
 * 6. Leroxacin
 * 7. Lesacin
 * 8. Levaquin
 * 9. Levokacin
 * 10. Levox
 * 11. Levoxacin
 * 12. Mosardal
 * 13. Nofaxin
 * 14. Quixin
 * 15. Reskuin
 * 16. Tavanic
 * 17. Volequin

Ciprofloxacin


 * 18. Bacquinor
 * 19. Baycip
 * 20. Bernoflox
 * 21. Ciflox
 * 22. Cifloxin
 * 23. Ciloxan
 * 24. Ciprinol
 * 25. Cipro
 * 26. Cipro I.V.
 * 27. Cipro XL
 * 28. Cipro XR
 * 29. Ciprobay
 * 30. Ciprocinol
 * 31. Ciprodar
 * 32. Cipromycin
 * 33. Ciproquinol
 * 34. Ciproxan
 * 35. Ciproxin
 * 36. Flociprin
 * 37. Floxin
 * 38. Ocuflox
 * 39. Proquin XR
 * 40. Septicide
 * 41. Velomonit

Avelox
 * 42. Avelox
 * 43. Avelox I.V.
 * 44. Vigamox

Floxin
 * 45. Akilen
 * 46. Baccidal
 * 47. Bactocin
 * 48. Danoflox
 * 49. Effexin
 * 50. Exocin
 * 51. Exocine
 * 52. Flobacin
 * 53. Flodemex
 * 54. Flotavid
 * 55. Flovid
 * 56. Floxal
 * 57. Floxil
 * 58. Floxin
 * 59. Floxstat
 * 60. Fugacin
 * 61. Inoflox
 * 62. Kinflocin
 * 63. Kinoxacin
 * 64. Liflox
 * 65. Loxinter
 * 66. Marfloxacin
 * 67. Medofloxine
 * 68. Mergexin
 * 69. Novecin
 * 70. Nufafloqo
 * 71. O-Flox
 * 72. Obide
 * 73. Occidal
 * 74. Ofcin
 * 75. Oflin
 * 76. Oflocee
 * 77. Oflocet
 * 78. Oflocin
 * 79. Oflodal
 * 80. Oflodex
 * 81. Oflodura
 * 82. Oflox
 * 83. Ofloxin
 * 84. Ofus
 * 85. Onexacin
 * 86. Operan
 * 87. Orocin
 * 88. Otonil
 * 89. Pharflox
 * 90. Praxin
 * 91. Puiritol
 * 92. Qinolon
 * 93. Qipro
 * 94. Quinolon
 * 95. Quotavil
 * 96. Rilox
 * 97. Sinflo
 * 98. Tabrin
 * 99. Taravid
 * 100. Tariflox
 * 101. Tarivid
 * 102. Telbit
 * 103. Tructum
 * 104. Uro Tarivid
 * 105. Viotisone
 * 106. Zanocin

Tequin
 * 107. Tequin
 * 108. Zymar

Nalidixic Acid
 * 109. Cybis
 * 110. Dixiben
 * 111. Dixinal
 * 112. Eucistin
 * 113. Innoxalon
 * 114. Jicsron
 * 115. Nalidic acid
 * 116. Nalidixan
 * 117. Nalidixate
 * 118. Nalidixic acid USP27
 * 119. Nalidixin
 * 120. Nalidixinic acid
 * 121. Nalitucsan
 * 122. Nalix
 * 123. Nalurin
 * 124. Naxuril
 * 125. NegGram
 * 126. Negram
 * 127. Nevigramon
 * 128. Nogram
 * 129. Sicmylon
 * 130. Unaserus
 * 131. Urisal
 * 132. Uronidix
 * 133. Wintomylon
 * 134. Wintron
 * 135. naladixic acid

Lomefloxacin
 * 136. Bareon
 * 137. Maxaquin

Norfloxacin
 * 138 Chibroxin
 * 139. Noroxin

Factive
 * 140. Factive

Davidtfull (talk) 03:59, 23 February 2009 (UTC)

Thanks David, but problem is we don't know which are brand names in english countries and if you look at the size of the list for some of those quinolones it is very long and would spam the introduction. That is why I usually use english country only brand names. I might try and register at medicinescomplete if I have the time.-- Literature geek |  T@1k?  00:10, 24 February 2009 (UTC)

The English brand names are the first names used. The other names are in the list that follows the English name. Sorry, should have been more clear about that. As such the English names would be Levaquin, Avelox, Ciprofloxacin (Cipro), Factive, Norfloxacin, Lomefloxacin, Tequin, Nalidixic Acid, Floxin and ProQuin.Davidtfull (talk) 02:37, 24 February 2009 (UTC)

Public Citizen / Flockhart / Cohen
Public Citizen:

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA PUBLIC CITIZEN, INC. ) 1600 20th Street, NW ) Washington, DC 20009 ) (202) 588-1000 ) ) Plaintiff, ) ) v. ) C. A. No. ___________________ ) FOOD AND DRUG ADMINISTRATION ) 5600 Fishers Lane ) Rockville, MD 20854 ) (301) 827-2410 ) ) Defendant. ) ______________________________________ ) COMPLAINT FOR DECLARATORY AND INJUNCTIVE RELIEF

The FDCA, 28 U.S.C. § 331, prohibits the introduction into interstate commerce of any drug that is misbranded. A drug is misbranded unless its labeling bears adequate warnings. 28 U.S.C. § 352(f).

Tendinopathy and tendon rupture associated with fluoroquinolone antibiotics has been observed since at least 1988. Since that time, reports of fluoroquinolone-induced tendon injuries have appeared repeatedly in the medical literature.

From November 1997 through December 31, 2005, the FDA adverse event database received reports of 262 cases of tendon ruptures; 258 cases of tendinitis; and 274 cases of other tendon disorders in patients using fluoroquinolone antibiotics. Because only a small fraction of adverse events typically are reported to FDA, the actual number of injuries attributable to fluoroquinolones is considerably higher. Analysis of the entire FDA adverse event database reveals that fluoroquinolones are implicated significantly more often in tendon ruptures than any other class of drugs. There has been no change in the rate of fluoroquinolone-induced tendon ruptures reported to FDA since December 31, 2005. From January 2006 through March 31, 2007, the FDA adverse event database received reports of 74 additional cases of tendon ruptures in patients using fluoroquinolone antibiotics for a total of 336 cases of tendon rupture reported since November 1997.

To date, FDA has not issued a decision on Public Citizen's petition, nor has it taken action to require adequate warnings of the risk of fluoroquinolone- induced tendinopathy and tendon rupture. Specifically, FDA has failed to require a black-box warning and enhanced provider information and, in addition, has failed to mandate an FDA-approved Medication Guide for patients. FDA has failed to act despite the significant and continuing reports to the agency of tendon injury linked to the use of fluoroquinolone antibiotics.

The considerable danger to public health occasioned by FDA's failure to require adequate warnings of the risk of fluoroquinolone-induced tendinopathy and tendon rupture counsels in favor of expeditious action on Public Citizen's petition.

PRESS RELEASE Jan. 3, 2008

Antibiotic Leads to Tendon Ruptures; FDA Ignores Risks

Public Citizen Sues FDA in Federal Court to Force Agency to Act On Petition Seeking Stricter Fluoroquinolone Warnings

"While the FDA sits idly by and ignores the problem, more people will suffer serious tendon ruptures that could have been prevented," Wolfe said. "The current warning is buried in a long list of possible adverse reactions and is far too easy to miss."

The FDA’s response to the Attorney General of the State of Illinois May 2005: “I am writing to inform you that the Food and Drug Administration (FDA) has not yet resolved the issues raised in your Citizen Petition submitted on May 24, 2005. Your petition request that the Agency take the following actions with  respect  to  the  entire  class of fluoroquinolone drug products and the potential adverse event of tendonopathy  and  tendon  rupture  to: 1)  revise  the  labeling  to  increase the warnings, 2)  provide "BLACK   BOX"  warnings,  3)   require  manufacturers  to issue   "DEAR HEALTH CARE PROFESSIONAL"  letter  that informs  these  professionals  of  the  potential  health  hazards  associated with the use of this class of drugs and  details  your  proposed  labeling  changes,  4)   supplement  information  provided to patients with bolded warnings,  and  5)  submit  the  issue  for review  and  analysis  to  FDA's  Drug Safety Oversight Board.  FDA  has  been  unable  to  reach  a  decision on your petition because it raises complex issues requiring extensive review and analysis by Agency officials...”

Public Citizen recieved a similar response one year later.

Letter to the Food and Drug Administration to immediately ban the antibiotic trovafloxacin (Trovan). (HRG Publication #1485)

“With eight other drugs in the fluoroquinolone family already available in the U.S, as well as dozens of other safer and equally or more effective drugs for infections, the removal of TROVAN from the market will not deprive doctors or patients of a drug which could possibly be considered indispensable. This is yet another instance of a lower standard for approving drugs in recent years than in the past, adding to the toll of Americans killed or seriously injured by drugs which should never have been approved in the first place.”

Congressional Testimony by Sidney Wolfe M.D. on Current Issues Related to Medical Liability Reform (HRG Publication #1724)

“n one study prior to approval in which the drug was used to treat prostatitis, almost 10% of the men (14 out of 140) given the drug developed evidence of liver toxicity. With eight other drugs in the fluoroquinolone antibiotic family available in the U.S, as well as dozens of other safer and equally or more effective drugs for infections, the removal of Trovan from the market would not have deprived doctors or patients of a drug that could possibly be considered indispensable. Instead of banning Trovan as was done everywhere else in the world, the FDA chose to “limit” its use in the United States to patients who were either hospitalized or in nursing homes.”

Petition to the FDA to Immediately Ban the Antibiotic Gatifloxacin (Tequin) (HRG Publication #1768)

“atifloxacin is indicated for the treatment of acute exacerbations of chronic bronchitis, acute sinusitis, community-acquired pneumonia, uncomplicated urinary tract infection, complicated urinary tract infection, pyelonephritis, and uncomplicated urethral and cervical gonorrhea. Other drugs to treat these conditions do not have the risks of gatifloxacin. When this drug is banned, it will be the fifth drug out of 13 approved in this to be taken off the market because of serious safety problems. The banned quinolone antibiotics are temafloxacin (because of hypoglycemia, renal failure, and hemolytic anemia)[1],[2] grepafloxacin and sparfloxacin (because of QT-interval prolongation and increased risk of heart arrhythmias),[3],[4],[5] and trovafloxacin (because of liver toxicity)”

“the rate of gatifloxacin-associated dysglycemia AERs per million prescriptions is 11 times that of moxifloxacin (which had the second highest rate among drugs studied), and the rate of gatifloxacin-associated dysglycemia AERs with death as an outcome per million prescriptionsis 16 times higher than that of moxifloxacin (which had the second highest rate among drugs studied)”

“the rate for gatifloxacin-associated dysglycemia AERs per million retail prescriptions is approximately 12 times that of moxifloxacin (the second highest rate among drugs studied).”

“the quinolone class of drugs possesses a risk profile that includes, in addition to hypoglycemia, cardiac toxicity, central nervous system (CNS) toxicity, liver toxicity, hemolytic uremic syndrome (HUS), joint disorder and/or tendon rupture (JD), and anaphylaxis.”

“the rates of gatifloxacin-associated dysglycemia AERs with the outcome of death per million  prescriptions are 16-18 times greater than comparator drugs with the second highest rates (moxifloxacin and levofloxacin in the analyses by Public Citizen and Frothingham et al, respectively)”

“even though the manufacturer reported that gatifloxacin had fewer adverse events involving joint disorder and/or tendon rupture, there is no evidence in the medical literature to support this conclusion; therefore, this should not be used as a reason to allow this drug to remain on the market...”

http://www.worstpills.org/results.cfm?drug_id=1243&x=30&y=10

Search results below include drug profiles where your selected drug is a secondary subject of discussion gatifloxacin (TEQUIN); moxifloxacin (AVELOX); sparfloxacin (ZAGAM) We list theses drugs as Do Not Use drugs because they are no more effective than similar drugs and cause irregular heartbeat. gemifloxacin (FACTIVE) We list this drug as a Do Not Use drug because it causes severe rashes and may cause irregular heartbeat and liver damage.

“antibiotics (drugs used to treat bacterial infections) are overwhelmingly misprescribed in the United States. Despite congressional hearings and numerous academic studies on this issue, it has become the general consensus that 40 to 60% of all antibiotics in this country are misprescribed. New studies continue to confirm the fact that a large proportion of antibiotic prescribing for both children and adults continues to be inappropriate. “

“One of the biggest-selling and most overprescribed classes of drugs in the United States is the family called fluoroquinolones. One clue that a drug your doctor wants to give you is in this class is the fact that the generic names of all such drugs approved in the United States include the sequence floxacin. These drugs have been alternatives for individuals allergic to, or with infections resistant to, other antibiotics. Some fluoroquinolones are commonly misprescribed for colds, sore throats, bladder infections, or community-acquired (as opposed to hospital-acquired) pneumonia. “

“You quote Tommy G. Thompson, the secretary of Health and Human Services, as saying doxycycline and penicillin are just as effective as Cipro (news article, Oct. 20). The major study in the field, published by United States Army researchers in 1993, does not support this statement. “

Dr. Flockhart:

Bitter Pills: Inside the Hazardous World of Legal Drugs,  written by Stephen Fried   1998

"The psychiatric effects of the fluoroquinolones are underappreciated by the medical profession as well as by the public," says Dr. Flockhart, who has treated more than 100 patients with severe psychiatric side effects.

…"There are people who are sitting ducks, waiting to have the side effects of these drugs..." Dr. David Flockhart, chief of the Division of Clinical Pharmacology at Indiana University School of Medicine.

"Quinolones are really the tip of the iceberg," he said. "It's the general fact that we're not good at recognizing and treating adverse drug reactions in primary care."

Dr. Cohen:

http://medicationsense.com/articles/may_aug_05/warning_antibiotics_052205.html

“Currently available quinolones available in the U.S. include Avelox (moxifloxacin), Cipro (ciprofloxacin), Factive (gemifloxacin), Floxin (ofloxacin), Levaquin (levofloxacin), Noroxin (norfloxacin), and Tequin (gatifloxacin). Over the years, other quinolones have been withdrawn from the market. In autumn 2004, the FDA mandated new warnings in the labeling of quinolones about nerve injuries associated with quinolones. The new warning reads:”


 * "Peripheral Neuropathy: Rare cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving quinolones, including [name of specific quinolone]. [The drug] should be discontinued if the patient experiences symptoms of neuropathy including pain, burning, tingling, numbness, and/or weakness or other alterations of sensation including light touch, pain, temperature, position sense, and vibratory sensation in order to prevent the development of an irreversible condition."

“This is an important, overdue warning. Moreover, it specifically tells doctors to discontinue treatment if any of these symptoms occur. You can find this warning regarding Cipro on page 823 of the 2005 Physicians' Desk Reference (PDR). However, you will not find this warning in the write-ups of Levaquin, Floxin, or Tequin in the 2005 PDR (I did not check the other quinolones). You can find the warnings elsewhere. For example, some are listed at the FDA website: www.fda.gov/medwatch/SAFETY/2004/sep04_quickview.htm. You can also find this warning in the package inserts for each of these drugs. “

“Nevertheless, quinolones are overused for minor conditions when other, safer antibiotics would suffice. My stance is that quinolones should be reserved for serious infections for which other antibiotics have been ineffective or for organisms that are only sensitive to quinolones. Even then, quinolones should be used carefully with close monitoring for side effects.”

“At the very least, people being placed on quinolones should be warned about possible side effects: joint, muscle, or tendon pain or rupture, nerve pain (burning, electrical sensations, tingling), muscle weakness, thinking or memory problems, heart palpitations, rapid heart rate, gastric problems, skin rash, or psychological symptoms. People have a right to informed consent, which means that they should be advised of the possible benefits and risks of any treatment. Because quinolone reactions sometimes occur quickly, patients need to be informed so that they can alert their doctors. Unless there is a medically urgent reason to the contrary, quinolone treatment should be stopped immediately.”

“Fluoroquinolone-linked reactions are nasty. These reactions vary from minor to extremely serious. Some are disabling. Recovery varies from individual to individual, with some reactions resolving quickly and others lasting years. As far as I know, none of the companies that manufacture quinolones has attempted to study how to help people sustaining severe quinolone reactions. The manufacturers seem content to list tendon ruptures or neuropathies when the FDA finally demands it, while ignoring the thousands of people who are suffering. To me, this is unconscionable.” Davidtfull (talk) 06:03, 23 February 2009 (UTC)

Some good info there. Thanks for posting. I agree fully with you that patients should be fully informed and that quinolones should not be used for minor infections. I think that patients and doctors need to be more aware of these adverse effects so if they occur they can discontinue treatment.-- Literature geek |  T@1k?  15:22, 25 February 2009 (UTC)

I added some new refs based on the information in this post.-- Literature geek |  T@1k?  03:00, 27 February 2009 (UTC)

beginning to understand the process here
I believe I have figured out why I am having such a tough time grasping some of the concepts being used here. We do not share the same definition regarding the word evidence. Being of a legal mindset, rather than a medical mindset, I subscribe to the legal meaning of the word which includes ALL the means by which facts are proved or disproved. Proof is not the same as evidence; it is the RESULT of the evidence. The way I have been stumbling around in the dark here looking for the batteries to my flashlight, it suddenly dawned on me that we do not share the same definition. It appears that rather than relying upon the perponderance of the evidence, (which requires taking all means into consideration) you and Doc are relying upon the requirement that it be proven beyond a reasonable doubt and published as such first, before even being considered. Yes oh yes? I will see if I can educate myself on such a foriegn and illogical concept ASAP so that I may quit aggravating you folks by presenting legal evidence rather than medical evidence. Failed to grasp that they are not to be considered one and the same here. The things you learn while trying to learn. But you got to give me credit for continuing to try.

On a side note I intend to draft a letter to the FDA and see if they will verify the position found within the document we are searching for. If that position had not changed since 1999, their response will be a reliable subsitute for the missing doc if it cannot be located. I also requested the members to try and contact the person to whom the letter was addressed to see if she still has the original. It had been a number of years since I had talked to her and I have no idea where her email address is. But we are a rather tight community here so someone may still be in contact with her.Davidtfull (talk) 02:08, 26 February 2009 (UTC)

Also will be reviewing my FDA correspondence files to see if I have anything that relates to this issue as well within something they had already sent me. Gotta drag the boxes out of the attic first and then sort through it all.Davidtfull (talk) 02:12, 26 February 2009 (UTC)

I have been able to locate the recipient of that doc and she believes she has the original in her files. She will check in the morning and if so arrange for me to have a copy asap.Davidtfull (talk) 04:50, 26 February 2009 (UTC)


 * Hey David, It looks like your heart is in the right place. Evidence from a medical perspective is the evidence which is supported by studies.  It comes in a number of different grades.  see Evidence_based_medicine  I always try to use the highest grade but that is not always available and thus one must use lesser sources.  I am cutting back on my wiki time to concentrate on other projects.  It has been fun working with you.  Cheers.-- Doc James  (talk · contribs · email) 18:12, 26 February 2009 (UTC)

Thanks for understanding Doc. I found that doc we were looking for, where the FDA says they don't do long term studies of these drugs, here are the links as it is three pages long. If you have a chance can you send me the full text of Ball's 1995 review? It is the one he cites back to in his '99 review.


 * http://www.fqresearch.org/jpegs/PHD_1.jpg


 * http://www.fqresearch.org/jpegs/PHD_2.jpg


 * http://www.fqresearch.org/jpegs/PHD_3.jpg

My defective heart is in the right place, or so says my latest MRI, it is the brain cells that I have lost and I can no longer find that seems to be misplaced. I understand the best evidence theory, (As it follows the same rules by which the decision of a Supreme Court trumps all previous caselaw) but what baffles me is how the medical community can consider something written by someone who works for, or is paid by, the drug companies to be any kind of evidence at all. Seems to me it would contain all the elements that had condemned by original article. That being bias, opinionated, contains original and unverifiable research, (as well as a shamelessly plagerizing each other's work) and presents only the manufacturer's POV.

I've been studying the manufacturer's papers for almost a decade now and they are truly a fascinating study in the use of smoke and mirrors to hide the true safety profile of any drug. And my study of the regulator agencies provides yet another fascinating study, that being in malfeseance and misfeseance. Anyhow, I've enjoyed this parlay with you as well. Always willing to learn something new, but being a natural born cynic...I guestion the validity of whatever it may be, and you have to prove it to me beyond a reasonable doubt before I'll bite.Davidtfull (talk) 00:45, 27 February 2009 (UTC)

You certainly deserve credit for trying David! I wouldn't use the word proof because as we know medical papers aren't proof in themselves but are evidence, it is just wiki needs reliable sources. I do appreciate you looking for those FDA documents. I think that it is a fair point to challenge reviews done by doctors employed by the manufacturer as it is to challenge individual case reports are evidence. I have gotten into debates on other articles about articles published by doctors working for drug companies.-- Literature geek |  T@1k?  03:07, 27 February 2009 (UTC)

Thanks for the scans of the FDA official letter. That will make a good ref.-- Literature geek |  T@1k?  03:14, 27 February 2009 (UTC)

couple of more references that may have value
“However, all fluoroquinolones, at dosages greater than those approved by the FDA, are associated with rare but serious adverse reactions, including disruption of glucose homeostasis, QT interval prolongation, and systemic rash.” Bertino J Jr, Fish D. The safety profile of the fluoroquinolones. Clin Ther. 2000;22:798-817.

“Clinicians should be aware of possible alterations in blood glucose, QTc interval prolongation, seizures, phototoxicity, tendinopathy, or CDAD with the use of any fluoroquinolone, especially in patients with other risk factors for these conditions. Clinicians should closely monitor for these adverse effects and appropriately adjust doses to minimize these risks. To provide safe treatment for patients needing antibiotic therapy, an assessment of the risk-benefit ratio may be warranted in the decision to use a fluoroquinolone” http://www.theannals.com/cgi/content/abstract/41/11/1859

“Safety concerns with fluoroquinolone therapy involve the use of these agents in specific populations. Patients with a history of long QT syndrome, hypokalemia or who are receiving Class Ia or class III antiarrhythmic agents (quinidine, disopyramide, procainamide, sotalol, amiodarone, dofetilide, ibutilide) are predisposed to development of Torsades de Pointes or other cardiac arrhythmias. These arrhythmias have been reported with levofloxacin and moxifloxacin. Disturbances of blood glucose, including symptomatic hypoglycemia and hyperglycemia, have been reported with all fluoroquinolones. The risk of dysglycemia is greatest in diabetic patients. However, hypoglycemia and particularly hyperglycemia have occurred in patients without a history of diabetes.” http://www.pbm.va.gov/criteria/Fluoroquinolone.pdf

“The FDA has conducted a new analysis of the available literature and post-marketing adverse event reports. This new analysis reconfirms that use of fluoroquinolones is associated with an increased risk of tendon rupture. It also demonstrates that despite the current warning of tendon rupture in the labeling for the fluoroquinolones, large numbers of tendon-related adverse events continue to be reported. The FDA considers this new analysis to be "new safety information" as defined in FDAAA.” (emphasis added) http://www.fda.gov/bbs/topics/NEWS/2008/NEW01858.htmlDavidtfull (talk) 08:45, 27 February 2009 (UTC)

Plagiarism
Instead of deleting large sections of possibly useful, yet plagiarised text, from Ciprofloxacin, why not re-write them and cite their sources? That way the article is improved not degraded. --Nsaum75 (talk) 07:04, 5 March 2009 (UTC)

That is my intent. The text I removed needs to be rewritten, better citations and needs to be put into a proper context. I am researching that and intend to submit these revisions when done. The article is quite bloated at the moment and there are a number of inadvertent plagiarisms left over from the original text addded years ago that needs to be addressed and corrected. In the above case the text used was a direct cut and paste from the article and taken out of context. No effort had been made to rewrite it or modify it in any way. These are copyright infringements that endangered the entire article and there are editors who wish to have all the quinolone content removed completely. So such text was removed temporarily until it could be properly presented.Davidtfull (talk) 14:13, 5 March 2009 (UTC)

A quinolone case where I live
I heard of a lady who is 70 years old who was given IV ciprofloxacin for a bone infection who developed seizures. Several doctors could not figure out what the problem was and never suspected the ciprofloxacin and continued to give her the ciprofloxacin. All they did was load her up with phenytoin in a vain attempt to stop the seizures. They happened to ask this doctor who I know what he thought and when he mentioned ciprofloxacin he said that is why she is having seizures and that the ciprofloxacin must be stopped for the seizures to abate. She is currently as I write this in a coma as a result of her severe repeated grand mal seizures. It is unknown whether she will have brain damage or not. She only was given it for a few days so hopefully she will recover. I will keep you updated. The doctor will be visiting her tomorrow. I have already said that he must write in her medical files that she must not be prescribed quinolones again.-- Literature geek |  T@1k?  21:05, 24 March 2009 (UTC)
 * Sorry to hear this, but these are the types of emails I have gotten every day for almost a decade now. Please keep me up to date on her status.  From what I have heard from others over the years her chances don't look good, so we will be praying for her.  But this statement is insane "Several doctors could not figure out what the problem was and never suspected the ciprofloxacin and continued to give her the ciprofloxacin."  This has been reported since these drug were introduced and listed in EVERY package insert.  Twenty seven years ago.  More than likely before any of these doctors even became doctors.  Didn't anybody bother to check the package inserts of the drugs this poor woman was one to see if this was one the side effects? Or perhaps even google this?  What is wrong with this picture?Davidtfull (talk) 00:01, 25 March 2009 (UTC)

Here is some background information regarding this:


 * Drug alerts
 * Seizures associated with Fluoroquinolones

Fluoroquinolones are widely used and are administered by several routes. Although the introduction of fluoroquinolones has increased the treatment options, their wide spread use has also revealed a wide spectrum of adverse reactions. Several new members of this group were marketed with great enthusiasm, but after the occurrence of serious adverse events during the early post marketing phase, some had to be withdrawn.

Eg: Temafloxacin (1992) Temafloxacin syndrome.

Trovafloxacin(1999) Lethal hepatic effects.

Grepafloxacin(1999) Torsade de pointes (1).

In Nepal, currently ciprofloxacin, ofloxacin and norfloxacin are approved for use. The fluroquinolones have a broad spectrum of side effects ranging from the milder ones that rarely require attention to the life threatening ones. The most common adverse reactions involve the gastrointestinal tract and are seen in 3% to 17% of patients The central nervous system effects are seen in 0.9% to 11% of the patients. These effects include mild headache, dizziness, hallucinations, delirium, seizures etc. The ability of fluoroquinolones to cause seizures has gained attention these days. Isolated reports of seizures have been reported with ciprofloxacin and ofloxacin. The risk of seizures during treatment with individual quinolones is currently unknown. Electrophysiological field potentials in animals are affected to varying degrees by different quinolones; the smallest effect was observed with ofloxacin, followed by ciprofloxacin and nalidixic acid, whereas there was an increasing excitatory effects with clinafloxacin, enoxacin, fleroxacin, lomefloxacin, moxifloxacin, and trovafloxacin. The pathophysiologic basis for the triggering of seizures probably lies in the binding of fluoroquinolones to GABAA receptors in the brain, blocking the natural ligand GABA; this results in CNS stimulation. Binding to this receptor is strongly influenced by the side chain in the 7 th position: quinolones with bulky moieties such as temafloxacin and sparfloxacin binds less efficiently to GABA receptors. (1)

It was noted that convulsions could occur both in patients with epilepsy and in those with no previous history of convulsions (2). However seizures have occurred predominantly in patients who were also receiving theophylline or a nonsteroidal anti-inflammatory drug (NSAID). NSAIDs may augment displacement of GABA from its receptors by the quinolones (3). The risk factors for fluoroquinolone-induced seizure may include seizure history, electrolyte imbalances, lack of dosage adjustment for renal insufficiency, and concomitant treatment wit h agents that lower the seizure threshold (4). Hence these agents should be used with caution in patients with known or suspected CNS disorders (seizure disorders, severe arteriosclerosis) that predispose to seizures or lower the seizure threshold and should be used with caution in the presence of other factors (eg, certain drug therapies, renal dysfunction, alcohol consumption etc) that predispose to seizures or lower the seizure threshold. If seizures occur during quinolone therapy, the drug should be discontinued and appropriate measures should be instituted. (5)

Sources:

1.Meylers side effects of drugs 14 th edition

2. Martindale- The complete drug reference: 33rd edition

3.Goodman and Gillman’s – The pharmacological basis of

therapeutics: 10th edition

4. Annals of pharmacotherapy. 2001 Oct; 35(10): 1194-98

5. AHFS Drug Information 2003

P. Subish

Lecturer

Department of Pharmacology.


 * Seizures Associated with Fluoroquinolones
 * The Annals of Pharmacotherapy: Vol. 36, No. 7, pp. 1162–1167.
 * Janine M Kushner, Howard J Peckman, and Clyde R Snyder

OBJECTIVE: To report two cases of seizures following administration of levofloxacin and ciprofloxacin. CASE SUMMARY: A 75-year-old white woman admitted to the hospital was prescribed levofloxacin for ischemic toes. After receiving three doses of oral levofloxacin, the patient experienced a seizure. One month later, the patient was rechallenged with ciprofloxacin and again experienced a seizure. The patient was hypomagnesemic and had elevated serum creatinine at the time of both seizures, and was hyponatremic during the second seizure. A 74-year-old white woman admitted to the hospital was prescribed levofloxacin for bacterial pneumonia. After five doses, the patient experienced a seizure. The woman had no electrolyte imbalances at the time of the seizure and no history of a seizure disorder. DISCUSSION: Quinolone antibiotics vary in their ability to induce seizures, with trovafloxacin having the greatest potential and levofloxacin possibly having the least potential. Neither patient had a history of a previous seizure disorder. Electrolyte imbalances are common with previous reports of fluoroquinolone-induced seizures. CONCLUSIONS: Although levofloxacin monotherapy has not been implicated in inducing seizures, it appears to be the causative agent in the second case. In the first case, the quinolones may have been a necessary, but not sufficient, cause in a patient with electrolyte abnormalities. Risk factors for fluoroquinolone-induced seizures may include seizure history, electrolyte imbalances, dose unadjusted for renal insufficiency, and concomitant treatment with agents that lower the seizure threshold.


 * Azar S, Ramjiani A, Van Gerpen JA.
 * Ciprofloxacin-induced chorea.
 * Mov Disord. 2005 Feb 28; [Epub ahead of print]
 * PMID: 15739219 [PubMed - as supplied by publisher]

Letter to the Editors Ciprofloxacin-induced chorea Susan Azar, MD, Amisha Ramjiani, MD, Jay A. Van Gerpen, MD Ochsner Clinic Foundation, New Orleans, Louisiana, USA email: Jay A. Van Gerpen (javangerpen@ochsner.org)

Ciprofloxacin-Induced Chorea

My colleagues and I read with interest the recent article in Movement Disorders by Post and colleagues[1] reporting propriospinal myoclonus secondary to ciprofloxacin use. We wish to expand the list of potential hyperkinesias that may be precipitated by ciprofloxacin by describing a singular patient we encountered. A previously healthy, 43-year-old woman presented with a subacute confusional state and involuntary movements. These conditions began during her treatment at another institution with ciprofloxacin, cephalexin, and amoxicillin clavulanate for an insect bite. She was awake, inattentive, continually smacked her lips, and made random, flowing, nonrepetitive movements diffusely. Dystonic posturing of her feet and motor impersistence on voluntary tongue protrusion were also noted. The antibiotics were discontinued. Serum, urine, and spinal fluid analyses were unrevealing. During her hospitalization, two witnessed generalized tonic-clonic seizures occurred. Five days following admission, she was discharged home in her usual state of health. She has not had recurrence of the aforementioned neurologic abnormalities. Ciprofloxacin has been linked to a variety of neurologic side effects, listed below in Table 1.[2][3] Of these side effects, perhaps status epilepticus is the best recognized.[4] Before our patient had two generalized tonic-clonic seizures, she manifested hyperkinetic movements most consistent with dystonia, chorea, and possibly a stereotypy. Heretofore, chorea has not been associated with ciprofloxacin toxicity, although the latter has caused oculogyric crisis and oral-facial dyskinesia,[5] which were both most likely acute dystonic reactions. After crossing the blood-brain barrier, ciprofloxacin can function as a GABA antagonist, producing neuroexcitation, which may potentiate neurotoxicity.[6] Ciprofloxacin primarily undergoes renal metabolism; thus, patients with impaired renal function may be more susceptible to ciprofloxacin-induced neurotoxicity. Additionally, concomitant use of certain medications with ciprofloxacin, including nonsteroidal anti-inflammatory drugs (NSAIDS), chloroquine, and cimetidine may enhance its neurotoxicity, presumably by pharmacokinetic mechanisms.[6] Our patient had normal renal function and was not taking any of the aforementioned medications along with ciprofloxacin, so undoubtedly additional factors play a role in ciprofloxacin's neurotoxicity.

Table 1. Neuropsychiatric side effects of ciprofloxacin in decreasing order of incidence Incidence Side effect > 0.1-3.0% Abnormal dreams Tremor Vertigo < 0.1% Alcohol intolerance Ataxia Migraine Psychosis Status epilepticus Peripheral neuropathy Oculogyric crisis

Whatever the mechanism(s), ciprofloxacin may induce serious neurologic sequelae. Our case expands this list to include chorea and underscores the risks of widespread prophylactic use of ciprofloxacin. References

1 Post B, Koelman JHTM, Tijssen MAJ. Propriospinal myoclonus after treatment with ciprofloxacin. Mov Disord 2004; 19: 595-597. Links

2 Drug facts and comparisons. St. Louis: A Wolters Kluwer Company. 2002.

3 Mulhall J, Bergmann L. Ciprofloxacin-induced acute psychosis. Urology 1995; 46: 102-103. Links

4 Isaacson S, Carr J, Rowan J. Ciprofloxacin-induced complex partial status epilepticus manifesting as an acute confusional state. Neurology 1993; 43: 1619-1621. Links

5 Pastor P, Moitinho E, Elizalde I, Cirera I, Tolosa E. Reversible oral-facial dyskinesia in a patient receiving ciprofloxacin hydrochloride. J Neurol 1996; 243: 616-617. Links

6 Rollof J, Vinge E. Neurologic adverse effects during concomitant treatment with ciprofloxacin, NSAIDS, and Chloroquine: possible drug interaction. Ann Pharmacother 1993; 27: 1058-1059. Links Susan Azar, MD, Amisha Ramjiani, MD, Jay A. Van Gerpen, MD Ochsner Clinic Foundation, New Orleans, Louisiana, USA Letter to the Editors Reply: Ciprofloxacin-induced chorea Bart Post, MD, Johannes H.T.M. Koelman, MD, PhD, Marina A.J. Tijssen, MD, PhD Department of Neurology and Clinical Neurophysiology, Academic Medical Centre, Amsterdam, The Netherlands email: Marina A.J. Tijssen (m.a.tijssen@amc.uva.nl) Abstract

The original letter to which this reply refers was published in Movement Disorders Article. Post B, Koelman JH, Tijssen MA. Reply: Ciprofloxacin-induced chorea. Mov Disord. 2005 Feb 28; [Epub ahead of print] PMID: 15739216 [PubMed - as supplied by publisher]

Reply: Ciprofloxacin-Induced Chorea

We thank Azar, Ramjiani, and van Gerpen[1] for their reaction to our article. Different hyperkinetic movement disorders have been described due to ciprofloxacin: propriospinal myoclonus,[2] Tourette-like syndrome,[3] and orofacial dyskinesia.[4] In 0.9% to 2.1% of the patients, other neurologic side effects have been described with the use of ciprofloxacin, including dizziness, headache, restlessness, delirium, hallucination, and generalized seizures.[5] Hyperkinesias are rare but should be considered as side-effect with the use of ciprofloxacin.

References 1 Azar S, Ramjiani A, van Gerpen JA. Ciprofloxacin-Induced Chorea. Mov Disord 2005; DOI: 10.1002/mds.20425 Links

2 Post B, Koelman JH, Tijssen MA. Propriospinal myoclonus after treatment with ciprofloxacin. Mov Disord 2004; 19: 595-597. Links

3 Thomas RJ, Reagan DR. Association of a Tourette-like syndrome with ofloxacin. Ann Pharmacother 1996; 30: 138-1341. Links

4 Pastor P, Moitinho E, Elizalde I, Cirera I, Tolosa E. Reversible oral-facial dyskinesia in a patient receiving ciprofloxacin hydrochloride. J Neurol 1996; 243: 616-617. Links

5 Christ W. Central nervous system toxicity of quinolones: human and animal findings. J Antimicrob Chemother 1990; 26(Suppl. B): 219-225. Links Bart Post, MD, Johannes H.T.M. Koelman, MD, PhD, Marina A.J. Tijssen, MD, PhD Department of Neurology and Clinical Neurophysiology, Academic Medical Centre, Amsterdam, The Netherlands


 * As stated within the 62nd meeting (1995) of the Anti-Infective Drugs Advisory Committee:

"…Three patients had their seizure after the first dose of flouroquinolone, one on ciprofloxacin and the other two on ofloxacin, one of which had received ofloxacin several months earlier…"(sic)


 * Generalized seizure and toxic epidermal necrolysis following levofloxacin exposure.
 * Christie MJ, Wong K, Ting RH, Tam PY, Sikaneta TG.
 * University of Toronto, Nephrology Associates, Scarborough, Ontario, Canada, and Scarborough General :Hospital, Scarborough.

OBJECTIVE: To report the case of a ciprofloxacin-allergic patient who developed a generalized tonic-clonic seizure and toxic epidermal necrolysis (TEN) following a single dose of levofloxacin.

CASE SUMMARY: An 87-year-old white woman was admitted to the hospital following a transient episode of unresponsiveness that had been accompanied by flailing of her limbs. Approximately 4 hours earlier, she had developed a pruritic rash on her trunk and limbs, and 3 hours before this had taken a first dose of levofloxacin. The fluoroquinolone had been prescribed for treatment of an upper respiratory tract infection. She had developed a skin rash approximately 3 years earlier following ciprofloxacin prescribed for a urinary tract infection. On admission, the patient had a normal neurologic examination. She was mildly hypomagnesemic (serum magnesium 1.7 mg/dL), with no other electrolyte imbalances present. Skin biopsy confirmed TEN. The lesions progressed to involve 30% of the body surface area and were managed with polymyxin B and gramicidin cream. Levofloxacin was discontinued on admission, and no anticonvulsants were prescribed. The woman remained seizure-free at discharge one week later. DISCUSSION: Generalized tonic-clonic seizures are a rare complication of levofloxacin therapy. TEN following levofloxacin use has, to our knowledge, as of March 28, 2005, been previously reported only once. The seizure and TEN were probably induced by levofloxacin as corroborated by the Naranjo probability scale. We believe that the previous adverse dermatologic reaction to ciprofloxacin sensitized our patient to levofloxacin. CONCLUSIONS: These rare adverse reactions to levofloxacin, involving disparate organ systems, can occur simultaneously. A previous dematologic adverse reaction to a fluoroquinolone can sensitize a patient to more severe adverse reactions (with onset after only a single dose of the subsequent fluoroquinolone). Further fluoroquinolone use should be avoided in such patients. Infect Control Hosp Epidemiol. 2005 Mar;26(3):273-80.


 * Here is a link to the seizure articles I have on the research site as well:


 * http://www.fqresearch.org/seizures.htm

Davidtfull (talk) 03:26, 25 March 2009 (UTC)

Thank you for the refs. I saw one of the refs mentioned magnesium. The lady by the way had low magnesium which I guess might be related to the quinolone chelating it. She was given magnesium to correct the imbalance which may have counteracted the effects of the quinolones somewhat by chelating it. She is doing a lot better, is out of her coma now and a brain scan came back normal so hopefully she will escape long term effects. I hope she doesn't get any of those delayed effects that you have spoken about. God only knows what would have happened if they had continued her on the ciprofloxacin.-- Literature geek |  T@1k?  19:00, 25 March 2009 (UTC)


 * They would have killed her and blamed it on old age. That is what would of happened, and I am not being sarcastic in the least.  And this would not of been reported as being associated with the ciprofloxacin, you can bet on that.  Thanks for letting me know she's doing ok so far.  You would be amazed at how many reports I get of old people never coming out of something like this.  So I was very concerned when I heard this from you.Davidtfull (talk) 03:04, 26 March 2009 (UTC)

Quinolone
Hello, Davidtfull. I worked on the quinolone article and came across a word you added to the article that I cannot find a definition for, at least not a definition that would make its use appropriate. The word is "pharmcore" and is found in the first sentence of the pharmacology section. My guess is that it is a typo, but I am not positive what word was intended, like "pharmacology" or "pharmacokinetics", so I did not change it. Thanks, Kjkolb (talk) 04:43, 28 March 2009 (UTC)


 * That appears to be typo while putting that definition into my own words. The quinolones are based on two types of ring structures, the quinolone nucleus and the naphthyridone nucleus. For example we see the use of term 'basic pharmacore' used here to make reference to the quinoline ring:


 * "The fluoroquinolones can cause varying degrees of QTc prolongation, with a decreasing rank order of sparfloxacin, grepafloxacin, moxifloxacin, levofloxacin, gatifloxacin, and ciprofloxacin. The presence of an amino group at the C-5 position on the basic pharmacore of the fluoroquinolones (e.g., sparfloxacin) prolongs QTc to a greater extent than a methyl group at this position (e.g., grepafloxacin); the least amount of QTc prolongation is associated with a hydrogen atom at this position, present in all other fluoroquinolones."


 * As well as within this article that describes this basic pharmacore:


 * Anti-Infective Agents in Medicinal Chemistry, 2007, 6, 49-56 49
 * Activities of Quinolones Against Obligately Anaerobic Bacteria
 * R. Schaumann* and A.C. Rodloff
 * Institute for Medical Microbiology and Epidemiology of Infectious :Diseases, University of Leipzig, Leipzig, Germany
 * http://www.bentham.org/cmcaia/sample/cmcaia%206-1/0004Y.pdf


 * I have made that change to the article, as well as within any of the other quinolone articles where that term was used. Thank you for your efforts on the quinolone articles and pointing out this error to me.  I have added the above reference as well, to help others who stumble across this who are not too sure what I am referring to.Davidtfull (talk) 11:30, 28 March 2009 (UTC)

Ofloxacin
A couple of users have been highlighted the lack of balance on the Talk:Ofloxacin ofloxacin article. I think that the article needs balanced out with pharmacokinetics, pharmacodynamics/mechanism of action, indications and other relevant sections. Currently only adverse reactions data is in the article. It is also a very commonly prescribed quinolone hence why I am bringing this to your attention.-- Literature geek |  T@1k?  02:42, 10 April 2009 (UTC)

I have skimmed over the moxifloxacin article. Looking in much better shape than it was in 6 months ago. I am going to skim over the other quinolone articles in the next week or 2 but mainly will be looking to do minor tweaks or fixing major issues as still have other articles that I am involved in editing.-- Literature geek |  T@1k?  02:44, 10 April 2009 (UTC)


 * The ofloxacin article is next on my list. Just trying to finish up the cipro, levaquin and avelox articles first before starting on that one.  I am sorting through my research regarding ofloxacin so it should not be too much longer before I start editing it.Davidtfull (talk) 03:52, 16 April 2009 (UTC)

Good job David. In your own time. The ofloxacin article sure needs work done to it especially with it being a commonly prescribed antibiotic.-- Literature geek |  T@1k?  09:12, 16 April 2009 (UTC)


 * I believe I have the articles completed for Ciprofloxacin, Levofloxacin, and Moxifloxacin. I cannot find enough information concerning Pefloxacin to include the various sections I had used for the others at the moment.  So adding those sections to the pefloxacin article will have to wait until my associates in Europe can research this and provide some documentation I can work with.  As such I will put that on the back burner and get started on the actual writing of the Floxin article.  I am still researching the dermatology section for the adr article so that is not ready to be added as of yet.  There is a ton of references regarding the dermatology problems so I am sorting through all those to find the best ones to use.


 * So when you get the chance I would appreciate a peer review of these four articles to correct any errors I may have made. In the meanwhile I will work on putting the floxin article together.  If you run across anything concerning pefloxacin's regulatory history I would appreciate you forwarding it on to me.  Thanks.  Davidtfull (talk) 05:18, 18 April 2009 (UTC)
 * David, please, please remember to keep it neutral and limit information to the drug that the article is actually about. See this partial revert of your latest edit. The first paragraph of the section was relevfant and NPOV; the second paragraph was neither. Fvasconcellos (t·c) 22:33, 17 May 2009 (UTC)

I saw this pop up on my watch list. I wouldn't worry too much about the pefloxacin article as it is not prescribed in many if any english speaking countries. I was just happy to see the horrible lay out (almost completely bullet pointed) and very limited data sorted out. I don;t think that it is a high priority quinolone article for the wikipedia project, maybe of medium importance. Good to see the ofloxacin article taking shape. FV is correct in that you should try to use citations which discuss ofloxacin. Also wording should not be opinionated or personal on an encyclopedic but should be worded in factual tone.-- Literature geek |  T@1k?  22:57, 17 May 2009 (UTC)

I thought the second paragraph was relevant, as well as factual, (as that is what the citations were given for) as it showed that such citations are quite common with this class and that J and J was not doing something out of the ordinary. Recently the FDA cited General Mills for its statements regarding cholesterol and Cheerios, that have been on the cereal box for years, so such letters are not uncommon in the least. But if you thought otherwise I have no objections to you removing it. In fact I had debated with myself whether to include the second paragarph or not and was actually going to delete it once I finished adding internal links to another section, as the more I thought about it I came to the conclusion that others may not see it that way. Just as you had. It is difficult to present a nuetral point of view when the information being presented is negative all in it self without any additional comments regarding it. It is even harder to present drug specific information when such information is grouped together as a class effect within the citations that do not specifically address one drug specifically by name, even though that information pertains to that specific drug by reference to the class. With ofloxacin being such an older drug relevant drug specific citations are hard to find as comments regarding it are grouped together with the current ones. Anyhow appreciate both of you working with me to avoid such mistakes or correcting them when I make them. I'll get the hang of this yet, or die trying.Davidtfull (talk) 23:10, 17 May 2009 (UTC)

BTW: I take no offense to either of you reviewing the articles and making needed corrections. It does help though if you were to let me know the reasoning behind such changes so that I may learn from such mistakes. Rather than just assume that I know all the ins and outs of this and deliberately trying to break the rules. I'm really not as smart as you seem to be giving me credit for. :) I'm used to writing scathing editorials and persasive briefs rather than politically correct encyclopedia entries.  This requires a 180 in my natural thought process and utterly foriegn to my particular style of prose.  We are trying to teach an old dog new tricks here.  But this old dog is willing to try and learn. Davidtfull (talk) 23:22, 17 May 2009 (UTC)

If the data is negative then you quote it as negative but avoid words that you would see in newspapers or in personal writings. Encyclopedias report the facts whether grusome, negative or positive or wonderful. The word blatant isn't very encyclopedic as to the reader the encyclopedia is then giving an opinion on the facts and also if the reference doesn't state blatant then it is mixing original research or personal opinion with facts. Encyclopedias aren't meant to be politically correct either, in the sense that they are not meant to water down the truth or overstate the truth but simply report verifiable facts in a non-emotional and non-opinionate wording. I have forgotten a lot of what I learnt in my english lessons about verbs. I had to relearn about redundancy on wikipedia as well.-- Literature geek |  T@1k?  23:42, 17 May 2009 (UTC)
 * Yep. This is the classic example on Wikipedia—after you say Adolf Hitler was responsible for the state-sponsored extermination of millions of people, do you need to say he was evil? Fvasconcellos (t·c) 12:22, 18 May 2009 (UTC)

Perhaps the problem is not with what I am saying, but how I am saying it. Even though the results remain the same:

"Keep it neutral and limit information to the drug that the article is actually about."

Would this then be considered a Neutral presentation of the known facts regarding the paragraph we are discussing? Or would this still be considered to be in violation of this policy? This section is about the deliberate, (blatant) and repeated, violations of the law by J and J when promoting false and misleading information found within the promotional items used by J and J to promote Floxin for an unapproved use. It is not as if they only recieved on such letter, the recieved numerous ones.

Not that we need to add this information to the article, I am just trying to understand how to apply the Neutral policy in such cases.

Would it be better to leave out any context? Not all readers are aware of the ramifications and seriousness of such actions without it though. Which would fail to communicate the fact that J and J deliberately and knowingly broke the law here and was busted by the FDA for doing so numerous times. As this is what the section was trying to communicate.

(Fact) The FDA stated that the promotional material used by Johnson and Johnson was misleading as it promoted the use of ofloxacin as being safe and effective for use in children, (a use that is not supported by substantial evidence and contraindicated with this class).

(Neutral Context) Within the package inserts it is stated that: “safety and efficacy of Floxin in children, adolescents...have not been established.”

(Fact) The FDA additionally considered the promotional material to be misleading as it failed to provide any balancing information regarding adverse events, risks, warnings or other such information.

(Neutral Context) The patient and the physician rely upon such information when engaging in a meaningful risk/benefit discussion.

(Fact) Johnson and Johnson’s dissemination of this promotional material for five months prior to submitting it to the FDA for approval was found to be in violation of 21 CFR 314.81(b) (3) (i). The FDA objected to this promotional material when it was submitted for approval five months after its use and requested that Johnson and Johnson immediately discontinue its use.

(Neutral Context) Such violations are common with other drugs found within this class when such material includes the use of misleading advertisements, the use of misleading promotional labels, the issuing of false and misleading press releases, distribution of false and misleading statements on web sites, make false and misleading claims regarding superior effectiveness or safety, promoting their drug for unlicensed and unapproved uses, as well as failing to provide relevant safety information. It is the policy of the FDA to notify offenders in writing to immediately discontinue the use of such material, just as they had done in the above cases concerning Floxin.

OR Just the Facts:

The FDA stated that the promotional material used by Johnson and Johnson was misleading as it promoted the use of ofloxacin as being safe and effective for use in children, (a use that is not supported by substantial evidence and contraindicated with this class). The FDA additionally considered the promotional material to be misleading as it failed to provide any balancing information regarding adverse events, risks, warnings or other such information. Johnson and Johnson’s dissemination of this promotional material for five months prior to submitting it to the FDA for approval was found to be in violation of 21 CFR 314.81(b) (3) (i). The FDA objected to this promotional material when it was submitted for approval five months after its use and requested that Johnson and Johnson immediately discontinue its use.

Davidtfull (talk) 14:58, 18 May 2009 (UTC)
 * Just the facts. You've hit the nail on the head now—that could be added to the article right now, as is. Fvasconcellos (t·c) 15:26, 18 May 2009 (UTC)

I would imagine then that this style of writing (as it applies to drug articles) consist solely of finding the facts, rewriting them in your own words while still preserving the original content, present them in some kind of logical order, (devoid of context or comment) and let the reader discern the meaning or relevance of the facts presented without any kind of guidance from the author. So rather than attempting to write a cohesive narrative, thereby providing context, you simply present a litany of related facts, (both pro and con) sub divided by relevant categories, with the bare minimum of prose that ties them all together. Correct? Or am I still getting this wrong somehow?Davidtfull (talk) 16:07, 18 May 2009 (UTC)

Sounds like you got it to me.-- Literature geek |  T@1k?  19:05, 18 May 2009 (UTC)


 * OK, then with this being the case allow me some time to review my contributions to these drug articles from that perspective, rather than a narrative perspective, and make the neccassary edits using the above template as a guide. With a much clearer definition of how they should be written I should now be able to spot my errors on my own and rewrite them accordingly.  Save you guys the hassle and the grief.  I am determined to get the hang of this, one way or the other.  But it appears that I am a slow learner here, though not from lack of effort on my part. :)  Davidtfull (talk) 00:13, 19 May 2009 (UTC)

Hi, David. It's been awhile, hasn't it? :) Well, here I am again with a few questions regarding your latest edit to Ofloxacin. Best wishes as always, Fvasconcellos (t·c) 03:06, 29 June 2009 (UTC)
 * 1) "In a 1986 issue of the Journal of Antimicrobial Chemotherapy, a leading article on quinolones in chest infections concludes that there is little reason for optimism about the role of fluoroquinolones in chest infections mainly because of problems with resistance, recurrence, and reinfection with Pseudomonas aeruginosa and S pneumoniae." Surely there are more recent sources to either support or refute this consideration? I'm sure I don't need to remind you that a 1986 article is now a quarter of a century old.
 * 2) Current consensus is that antibiotics do little for acute sinusitis, unless there is a reasonable suspicion of acute bacterial sinusitis, in which case (if memory serves) quinolones are not recommended as first- or second-line treatment. Do we really need to mention this in the Ofloxacin article? It's more appropriate for the Sinusitis article.
 * 3) Snow et al. in no way proved the futility of antibiotics againt bronchitis; they found that azithromycin provides no real improvement. If other authors have proved the futility of antibiotics in managing bronchitis, that's another story.
 * 4) Again, an article on a single antibiotic in a specific class really, really does not need to mention the inappropriateness of antibiotics for treating the common cold; neither does it need to mention that empiric antibiotic treatment of sore throat is unnecessary/not effective/etc. This is good information for the acute pharyngitis article, or even for an antibiotic misuse article, but not for the Ofloxacin article.


 * Thanks for your input. As always its appreciated.  Will work on your suggestions and update the references as needed.  Unfortunately we do need to remind physicians that the quinolones are useless when treating acute sinusitis that is NOT bacterial in nature as this is where the most scripting abuse takes place.  And this was placed under the risk/benefit assesment section so I would think it to be appropriate.  The same with bronchitis and sore throats as well.  If physicians were not handing these drugs out like halloween candy for sore throats and common colds then yes I would agree with you.  But this is what is taking place and so under the risk/benefit section I felt that these issues should be raised for two reasons.  ONE to remind the physician of the futility of such treatment and TWO to alert the patient who recieved such a prescription to question it.  It may dumb down the article a bit but there are so many ignorant physicians and patients out there that it is a neccassary evil. I will find the newest references that support these positions and update the references accordingly and you can take another look at it and see what additional work is needed. The last edits were rough drafts to get the ball rolling again.


 * I've been out of it for a while so I have not been doing any real editing. Had some problems regarding someone who is a sociopath who is falsely claiming to have been injured by these drugs (and also managed to shut down the longest running quinolone forum as well with his craziess) and I was so pissed off about the situation I could not even begin to edit anything in good faith. Also blew out my knee and achilles again a while back so have been in a lot of pain.  Can't do much editing while on heavy duty pain meds and pissed off to the max, but these where the last of the edits for the floxin article so I thought I would throw then out there and await your response.  Gives me something to do once you give your input while my leg heals up so I can walk again. :)


 * But nothing has changed since that 1986 article even though it is twenty years old. The quinolones are still useless for such infections for the most part.  But I agree we need a newer reference to support that.  Just got lazy on this end I would imagine.  Been reading these sources for over a decade now so don't even think to check the dates anymore. But I do have better references we can use.  So we can work together to reach a concensus regarding these issues just as we have done in the past.  Just let me dig through my files and update accordingly within the next couple of days and you can take another shot at it if needed.  If I cannot support it then we will have to remove it.  Tis the law of wiki.  :)

Davidtfull (talk) 01:08, 30 June 2009 (UTC)

Did a little digging and came up with the following. In regards to concern #1:

Suggested change in opening statement:

In a 1986 issue of the Journal of Antimicrobial Chemotherapy, a leading article on quinolones in chest infections concludes that there is little reason for optimism about the role of fluoroquinolones in chest infections mainly because of problems with resistance, recurrence, and reinfection with Pseudomonas aeruginosa and S pneumoniae. In 2001 this controversy continues. Williams et al comments on bacteria that are becoming increasingly resistant to the fluoroquinolones, just as Davies et al had predicted back in 1986, and strongly recommends limiting their use. Stating that “Widespread use of fluoroquinolones among hospitalized patients has induced more frequent resistance among nosocomial pathogens.”

How then would you suggest I incorporate the following, which supports the position taken by Davies et al twenty years ago?

An important issue associated with the use of fluoroquinolones in the therapy of respiratory tract infections is the fact that fluoroquinolones also are used to treat other infections. The use of these agents for other infections means that the population already had been exposed to fluoroquinolones before their widespread use in respiratory tract infections. Exposure of normal flora in these patients to subbactericidal concentrations of fluoroquinolones may allow resistant strains to emerge. Cross-resistance is a well-recognized problem with fluoroquinolones, , and the enormous prior exposure of the population to these agents may have created resistant strains in the normal flora of the mucosal surfaces, skin, gastrointestinal tract, and reproductive tract. In addition, prior exposure may result in increasing MICs due to subtle mutations of topoisomerases, which then may leave the microorganism only one step from a mutation that will produce overt resistance. An example of such subtle topoisomerase topoisomerase an enzyme involved in DNA replication that introduces a single-strand nick in the DNA enabling it to swivel and thereby relieve the accumulated winding strain generated during unwinding of the double helix. mutation is seen with fluoroquinolones such as levofloxacin, which have been recommended and widely used for the therapy of pneumococcal pneumonia when penicillin resistance to S. pneumoniae is a problem Unfortunately, the population has had considerable prior exposure to earlier fluoroquinolones, which has allowed rapid emergence of fluoroquinolone resistance in S. Pneumoniae  Failure of treatment of pneumococcal pneumonia due to resistance to levofloxacin recently has been described. This example confirms the problem of cross-resistance and further mutations resulting in increased resistance and suggests that newer fluoroquinolones may be less effective or even ineffective against S. pneumoniae.

You have to keep in mind that ofloxacin is a VERY old fluoroquinolone, (over twenty years now) as such studies dealing with it are VERY OLD as well. You will not find anything current regarding it so we have to use studies that are rather dated. Controversy about the efficacy of ofloxacin therapy for ABECB has been ongoing since day one resulting from conflicting clinical trial results. For example within one randomised study the clinical cure rate was less than 35% with a 10% failure rate. In another study the cure rate was found to be equal to amoxycillin/clavulanic acid.

You can go into the edit mode and should be able to bring up the references cited above. But the bottom line that I am trying to state here is that the risk/benefit of ofloxacin in treating respritatory infections does not support its use due to ever increasing bacterial resistance as well as the results of previous randomised studies that failed to show acceptable efficacy for chronic bronchitis. Not that it really matters as ofloxacin has been discontinued and replaced by levaquin anyhow.
 * David, sorry for the delay in getting back to you. I really can't write now, hence the terse replies—I'll add more later. Fvasconcellos (t·c) 22:03, 3 July 2009 (UTC)

Ofloxacin continuing discussion
(added this heading to make it easier to continue this discussion)

In regards to concern #2 the fluoroquinolones are considered third line agents, but are marketed as first line agents. Hence the need to mention this. Not all physicians question the lies that spew forth from their drug reps.
 * Well, I'll give you that, but shouldn't it be in the Scripting abuse section? Fvasconcellos (t·c) 22:03, 3 July 2009 (UTC)

The scripting abuse section is fairly broad. There is no question that this class is abused to the max. I was addressing the specific common uses that are promoted by the manufacturer, but lack support within the liteature that would justify their common use as first line agents. That being:

Respiratory infections

Chronic bacterial prostatitis

Infectious diarrhea

and

Uncomplicated cervical and urethra gonorrhea

The question being does the end justify the means in the above four cases? In these four cases I believe that the liteature (that is not written by some spin doctor employed by the manufacturers) supports a resounding "NO" for a variety of reasons.

In regards to concern #3 that has been removed. Inappropriate use in this article. Failed to read it completely, my apologies.
 * No need to apologize, thank you for taking care of it. Fvasconcellos (t·c) 22:03, 3 July 2009 (UTC)

In regards to #4 we will have to agree to disagree here. This section deals with risk/benefit regarding ofloxacin. Which is OFTEN times prescribed to treat the common cold, sore throat, viral infections, or whatever sinus condition the patient presents with. Rarely, if ever, does the treating physician take a sample to see what bacteria is present. Show up with a head cold or sore throat and leave with a script for floxin. This is the LEADING cause of scripting abuse for this drug in particular. The overwhelming majority of those who are on the forums who had a reaction to floxin have stated it was prescribed to treat a common head cold or some other non bacterial sinus condition. So it appears that the average physician is unaware of the futility of this or doesn't give a damn. One or the other. Either way I feel that it would be appropriate to remind both the physician and the patient of this under the risk/benefit section. Davidtfull (talk) 04:28, 30 June 2009 (UTC)
 * If you do believe it is worth mentioning, then I'd like to see more references along the line of Lautenbach et al.—high-quality studies focusing specifically on inappropriate fluoroquinolone use. Fvasconcellos (t·c) 22:03, 3 July 2009 (UTC)


 * Here is another study along the lines of Lautenbach et al that I will add to the floxin article as you have requested:


 * Within a 1994 study it was found that 75% of the prescription issued within a long term care setting were judged to be inappropriate by the authors. In more than fifty percent of the cases reviewed, ciprofloxacin was not considered to be a first line agent.


 * J Am Geriatr Soc. 1994 Jan;42(1):28-32.
 * The appropriateness of oral fluoroquinolone-prescribing in the long-term care setting. Pickering TD, Gurwitz JH, Zaleznik D, Noonan JP, Avorn J. Harvard Medical School, Boston, MA.  http://www.ncbi.nlm.nih.gov/pubmed/8277111


 * http://www.journals.uchicago.edu/doi/pdf/10.1086/501798?cookieSet=1
 * Davidtfull (talk) 04:23, 3 September 2009 (UTC)

Here are a few additional references that I have on file that perhaps would be usefull. Lautenbach et al is indeed a quality reference, but also a rare find. There is SO much promotional material masquerading as studies that most of the later stuff is about useless. You will find, as LG had mentioned in our discussions with Doc, just about everything written about this class that supports it use to treat respritatory infections was written by a half a dozen or so "consultants" employed by the manufacturers. Since Ofloxacin was replaced by cipro and levaquin in the mid nineties it will be hard to find drug specific articles that refute its use in the above four cases. When ofloxacin was in its hayday a century ago it was mainly used to treat urinary tract infections.

But on the other hand we are seeing a resurgance as it has gone generic and used in third world countries as the other drugs in this class are cost prohibited. And it is being used in these four indications, so a discussion regard risk/benefit should point out the fact that such use is inappropriate. Seperate from scripting abuse. In my opinion anyhow. But I could be wrong. Anyhow when you get a moment take a look at these. This article ain't going anywhere and I will not be adding anything to it for the moment without a concensus reached regarding your concerns. I think it covers the drug completely and is well referenced, so as far as I am concerned I am done with it other than these details here. So no rush for a response from you. When you get a chance we will discuss this further and come to some kind of compromise or understanding.

BTW: Before you raise the issue of the dates remember this drug is a century old as well, so relevant studies would be too. :)

ReAntibiotic Resistance Among Gram-Negative Bacilli in US Intensive Care Units Implications for Fluoroquinolone Use Melinda M. Neuhauser, PharmD; Robert A. Weinstein, MD; Robert Rydman, PhD; Larry H. Danziger, PharmD; George Karam, MD; John P. Quinn, MD JAMA. 2003;289:885-888. “The most alarming trend detected in the current study was the decreasing activity of ciprofloxacin.”

“From 1995 to 2002, inappropriate antibiotic prescribing for acute respiratory infections, which are usually caused by viruses and thus are not responsive to antibiotics, declined from 61 to 49 percent. However, the use of broad-spectrum antibiotics such as the fluoroquinolones, jumped from 41 to 77 percent from 1995 to 2001. Overuse of these antibiotics will eventually render them useless for treating antibiotic-resistant infections, for which broad-spectrum antibiotics are supposed to be reserved.” http://www.ahrq.gov/research/nov07/1107RA29.htm

“The use of fluoroquinolones is fairly restricted in Europe, and these agents are not commonly used in the outpatient setting.” http://www.chestjournal.org/content/125/5/1888.full

“The overall susceptibility to ciprofloxacin decreased steadily from 86% in 1994 to 76% in 2000 and was significantly associated with increased national use of fluoroquinolones.” http://jama.ama-assn.org/cgi/content/abstract/289/7/885

“Evidence is mounting that suggests a link between inappropriate fluoroquinolone use, development of antimicrobial resistance against the entire fluoroquinolone class, and clinical failure. To maintain the activity of the fluoroquinolone class, clinicians need to implement an evidence-based approach to antimicrobial selection, particularly a strategy in which the most pharmacodynamically potent fluoroquinolone is matched, on an empiric basis when required, to anticipated bacterial pathogens.” http://goliath.ecnext.com/coms2/gi_0199-971293/Maintaining-fluoroquinolone-class-efficacy-review.html

BMJ 1994;308:1437 (28 May) Letters Ciprofloxacin in general practice EDITOR, - The Lesson of the week by Roland J Korner and colleagues highlighted the dangers of fluoroquinolones.(1) We have also noted that patients with chest infections have been treated with ciprofloxacin in general practice; the slower resolution of their Streptococcus pneumoniae infection required a change of antimicrobial agent, and one patient died. We understand, however, that ciprofloxacin is not promoted as first line treatment in general practice for community acquired chest infections, but some general practitioners in our area have provided promotional material that does. This material contains data showing that 14.4% of bacterial pathogens in acute exacerbations of chronic bronchitis are S pneumoniae. Bantz and colleagues (some of whom worked for Bayer) are cited in Bayer's promotional leaflet for Ciproxin; they mentioned a >95% resolution rate but compared only doxycycline with ciprofloxacin and made no reference to bacterial pathogens.(2) In the same supplement to the American Journal of Medicine, however, other papers gave less favourable views-for example, "the activity of ciprofloxacin against Streptococci and Enterococci is marginal, at best."(3) The only other reference concerning efficacy that is cited in Bayer's promotional leaflet is a study of just 34 patients.(4) Those with Haemophilus influenzae rapidly recovered, and these organisms were not culturable beyond three days. Of those with S pneumoniae infection, five still had positive results after three days, five after 11 days, and one after 25 days. Five patients had a relapse and were then treated with either amoxycillin or cotrimoxazole and clinically recovered. Six patients acquired S pneumoniae infection during or after treatment, and three required treatment. Two patients had rising minimum inhibitory concentrations to ciprofloxacin in S pneumoniae, with organisms being isolated further into ciprofloxacin treatment. In the same issue of the Journal of Antimicrobial Chemotherapy a leading article on quinolones in chest infections, concludes that there is little reason for optimism about the role of quinolones in chest infections mainly because of problems with resistance, recurrence, and reinfection with Pseudomonas aeruginosa and S pneumoniae.(5) Clearly, ciprofloxacin is not a suitable agent for use in general practice for the blind initial treatment of chest infections and should not be so promoted. We believe that there are major discrepancies between the promoted image and the clinically interpreted usefulness of ciprofloxacin. We hope that this sort of problem is not widespread in the pharmaceutical industry but wonder how extensive it is considering the gamut of drugs being actively promoted, often to those without the time or resources to easily and critically interpret the data presented to them. P M W Donaldson, A P Palleti, M P Carroll Southampton University Hospitals Trust, Southampton SO9 4XY. References and Citations: 1. Korner RJ, Reeves DS, MacGowan AP. Dangers of oral fluoroquinolone treatment in community acquired upper respiratory tract infections. BMJ 1994;308:191-2. (15 January.) [Free Full Text]

2. Bantz PM, Grote J, Peters-Haertel W, Stahmann J, Timm J, Kasten R, et al. Low-dose ciprofloxacin in respiratory tract infections. Am J Med 1987;82 (suppl 4A):208-10.

3. Barry AL, Jones RN. In vitro activity of ciprofloxacin against Gram positive cocci. Am J Med 1987;82 (suppl 4A):27-32.

4. Hoogkamp-Korstanje JAA, Klien SJ. Ciprofloxacin in acute exacerbations of chronic bronchitis. J Antimicrob Chemother 1986;18:407-13. [Abstract]

5. Davies BI, Maesen FPV. Quinolones in chest infections. J Antimicrob Chemother 1986;18:296-99. [Medline]

Davidtfull (talk) 22:27, 4 July 2009 (UTC)

See talk page in article
HI Dave, I noticed that you added a see talk page in the main article, dunno if it is still in article but references to the talk page should not be made in the main article text. I think that you wanted to remove the trade names list, not sure why perhaps it was too long. If list was too long usually it is better to shorten it to common trade names or else just delete it if names are already in the introduction or lead as it is called.-- Literature geek |  T@1k?  03:32, 21 May 2009 (UTC)


 * That was just temporary for a day or two as I was changing over to using redirects instead and wanted to discourage people were adding trade names. I removed that reference to the talk page.  The trade name edit was in response to issues raised by Fvasconcellos.  Do you think it better to remove that heading completely?  Or to leave it as is (minus the reference to the talk page) letting other editors know to use redirects, as well as letting the reader know that redirects are being used, rather than listing trade names?  My intent is to just use the most common trade names somewhere within the intro and leave it at that.  Especially since there are so damn many different names used for the same drug and when you include generics the list becomes unmanageable.Davidtfull (talk) 23:40, 23 May 2009 (UTC)

Ciprofloxacin: Thanks for your references
Thank you for your quick answer to my fact tag! Just out of curiosity: Does the FDA really say that ciprofloxacin is only to be used if everthing else fails? The references seem to run more along the lines of can be used if nothing else helps. The EMEA is a bit less strict in that respect. I'd also consider CPX as a second- to third-line antibiotic, but I've never heard that the use were restricted to life-threatening conditions. --ἀνυπόδητος (talk) 15:05, 1 July 2009 (UTC)


 * The opinion that the use of ciprofloxacin should be restricted to life threatening infections also applies to all of the drugs found within this class. For example the European body (EMEA) stated (in 2008) that due to safety concerns, mainly related to an increased risk of adverse hepatic reactions, it recommended restricting their use.(norfloxacin and moxifloxacin) The European body (EMEA) said it had concluded that these drugs should ONLY be prescribed for acute bacterial sinusitis, acute exacerbation of chronic bronchitis and community-acquired pneumonia when other antibiotics cannot be used or have failed. (Emphasis added)  Within an European Dear Doctor Letter Bayer states that: When prescribing moxifloxacin, consideration should be given to official guidance on the appropriate use of antibacterial agents which is ESPECIALLY RELEVANT with regard to treatment of less severe infections. (Emphasis added)


 * Jim Hoover, regional manager for state government affairs for the Bayer Corporation stated that:
 * "Normally the quinolone class of drugs is used in patients who have failed at least one prior therapy. The patients tend to be fairly ill and require relatively acute care…These drugs are often the last step before admission into the hospital..."


 * On February 16, 2006, the manufacturer of gatifloxacin announced that the drug’s label would change. According to a Food and Drug Administration (FDA) press release, “Since the approval of gatifloxacin in 1999, there have been cases of life-threatening events reported globally in patients treated with the drug." David Jurrlink, M.D., one of the original authors of "Outpatient Gatifloxacin Therapy and Dysglycemia in Older Adults" stated "Speaking as a clinician, I would NEVER prescribe this drug."   Sidney Wolfe of Public Citizen stated "This represents a unique danger in the absence of a unique benefit...This is more than enough reason to think about petitioning the Food and Drug Administration to BAN this drug, and we probably will."


 * The FDA of course is about as useless an organization as we have here in the States as it is both bought and paid for by the drug companies. Patient safety is the least of their priorities.  So no, it is not the official stance of the FDA that this class be restricted in it use, with Trovan being the lone exception at the moment.  This is the stance of prudent physicians (as found within the latest literature) based upon the horrendous safety profile of this class, as well as ever increasing bacterial resistance due to prescribing abuse.


 * More than half of the drugs found within this class have been removed from clinical use due to severe and fatal toxicity issues. Most recently Tequin, and as of note Ofloxacin, which has recently been removed by the manufacturer as well.  The manufacturers of levaquin are facing tens of thousands of product liability lawsuits due to its safety profile, with moxifloxacin soon to follow.  As such the consensus reached by physicians who are aware of these issues is that such use be restricted to life threatening infections.  Where as those physicians who remain ignorant of this, see nothing wrong with using them as first line agents for the frivolous of reasons.


 * There are any number of references I could have used to support that statement but no sense in postings dozens of references that state the same thing. So I tried to use the ones that had the broadest range over the greatest time span.  I appreciate you taking the time to question this statement and I hope I have provided sufficient documentatin regarding it.  It is to be expected that anything that reflects poorly on this class will be challenged due to the appalling ignorance found within the medical community regarding its true safety profile, so I take no offense to you doing so.Davidtfull (talk) 02:27, 2 July 2009 (UTC)

You do not have to convince me that the quinolones are the antibacterials with the worst safety profile (except perhaps the sulfas). Being a pharmacist, I know about liver toxicity, tendon ruptures etc.

My concern is the tone of the ciprofloxacin article. The lead section alone states three times that this drug is only for the treatment of life threatening infections (counting "a drug of last resort when all other antibiotics have failed") and then continues "Any other use is to be considered off label since it has not been approved by the FDA", which is true for every single drug there is. There is hardly a section without a statement or warning about the dangers of ciprofloxacin. All this is true, but the impression the article makes to, say, an intelligent layman, is that some editor wants to make a point. In other words, the artilce SEEMS to say more about you than about ciprofloxacin. Having read some of your previous conversaion on your talk page, I cannot put it better than Fvasconcellos who noted that the article about Adolf Hitler does not need to state that he was evil.

Please do not get me wrong: I know you mean well, and I know it is true what the article says. (Well, most of it – I haven't double checked every single fact.) All I ask for is a more encyclopedic tone, or understatement if you like, to make it clear beyond doubt that this isn't the work of someone who simply wants to ruin Bayer, but a well researched and scientifically correct article. Best regards --ἀνυπόδητος (talk) 11:12, 3 July 2009 (UTC)


 * I fully understand where you are coming from. We are working on toning it down if you will.  LG had gone through the whole article and made constructive changes a while back and I did not object to a single one.  It still needs work to get to an encyclopedic tone, no argument there from me at all.  I am rather new at editing in this fashion and this is obviously my weakest point.  Though my facts are spot on, the manner in which they are presented indeed needs a lot of work to reach a more neutral tone.  I guess this comes from arguing with physicians for decades who have told me I was full of it, these drugs cannot possibly have such reactions associated with thier use,  whenever I raised these issues while seeking my own medical care.  So no offense taken in the least to your comments.


 * No, a person does not need to state that Hitler was evil. That's a given that anybody with a functioning brain cell can easily grasp. But here we are faced with a situation where the average physician believes these drugs to be the greatest and safest thing since sliced bread.  And the average patient believes there is nothing inherently dangerous about an antibiotic.  It's an antibiotic, what could possibly be the harm there?  Any suggestions as to how to counteract these perceptions and still remain nuetral within the article?  I will take seriously your concerns and delete the repative warnings that you had noted, as sometimes one is too close to something to see what others see at a distance.


 * But amongst the thousands of those within the medical community I have dealt with over the past twenty years you indeed are an exception rather than the rule when you stated that:


 * "You do not have to convince me that the quinolones are the antibacterials with the worst safety profile (except perhaps the sulfas). Being a pharmacist, I know about liver toxicity, tendon ruptures etc."


 * An appalling number of your peers remain clueless. Perhaps those are whom I am addressing a bit too repatively within the article, rather than an intelligent layman.  The layman gets it, it is the medical community that fails to.  But fair is fair and I recognize that I am being a bit heavy handed here and will make the changes required, as you had noted, to eliminate as much of that as possible within the article.Davidtfull (talk) 14:56, 3 July 2009 (UTC)

Thank you for your constructive attitude – I will do a bit of copyediting as time and concentration permits. If you object to / revert any of my edits, please tell me so we can discuss the issue.


 * Appreciate you being understanding as well. This is far from being an easy task for me to adapt to.  But if you will note I have already made several of the changes you mentioned.  I have no problem working with editors who respect my point of view and help guide me as you have done.  No question that I am going to screw up here and I am far more responsive to a guiding hand that a kick in the butt.  But keep in mind I am but one person who has worked on this article.  Not all of the errors made are mine. :)Davidtfull (talk) 15:28, 3 July 2009 (UTC)

I had recently responded to your concerns raised on the wiki pharma talk back in June. It appears that you had taken issue with the regulatory time line being included within the articles. I had also checked out a number of drug articles you had written and noticed that you make no mention of adverse events within a significant number these articles, as well as excluded a number of sections that wiki requires to be included within drug articles. Curious that, considering that you stated that you are a pharmacist. Perhaps you could explain this discrepancy?Davidtfull (talk) 05:16, 17 July 2009 (UTC)


 * First of all: I just read my post at WT:PHARM again, and realised that it could be taken as a personal offence. At the time I wrote it, I didn't know that large portions of the article are the work of one author; I just thought it turned like that for lack of copyediting from experiences writers. I apologise if you took my post as an offence against you, it certainly wasn't meant like that.
 * That being said, to address your concerns about my drug articles: They are mainly articles about drugs in Phase II or III, so there is little information available about clinical questions like adverse effects. If Phase II results are bad, a drug doesn't enter Phase III anyway, and if it's good, the interesting information is still to come when Phase III results are published. Furthermore, many of these drugs will probably never be marketed, so it is way to much work to read all the literature about each drug and write everything down in the article. So, my strategy is to write incomplete articles (see WP:Stub). I certainly think that they should be expanded as soon as Phase III results are out, or at least when a drug goes to market. If not, then it is probably enough to add a sentence on the lines of "Development of this drug was terminated because of...".
 * If you read my drug stubs again, you will notice that I carefully avoided any positive information as well. It's just neutral facts like chemistry, planned indication, mechanism, manufacturer. On the contrary, I tend to remove sentences like "This drug is likely to revolutionize the treatment of...". So I don't think the articles are unduly positive about their respective subjects. --ἀνυπόδητος (talk) 12:42, 17 July 2009 (UTC)

Fair enough. I just thought it strange is all considering your concerns about the quinolone articles and finding no safety data on any of those articles. It is very hard to express ones thoughts without being misunderstood when you are not talking face to face. But we all have the same common goal here and that is to present factual and well researched articles that have value. As I noted in my response on WT:PHARM the quinolone articles are rather unique. And a lot of misinformed or uninformed editors immedately assume something underhanded is taking place, when in fact no such thing is going on.

I'm rather new at writing at an encyclopedia level is all and have a lot to learn. A lot of editors who have been around a while have helped me tremendously in that regard. Just as you have recently done. I've made a number of edits to reflect this and thereby toned down the articles considerably. But the hostility I have encountered thus far is rather daunting. As such it is rather difficult not to be on the defensive.

What I find so fascinating here is the fact that I had no interest in even being an editor here to begin with. My whole involvement began when I asked that the Black Box warnings be added to the quinolone articles. I did not start out with any intentions of rewriting the quinolone articles. Other editors had encouraged me to do so due to my expertise and the horrible shape that the articles were in. But the moment I began working on them suddenly everybody has an opinion, though they had laid dormant for years. So yeah, I do feel a bit put upon at times and respond accordingly but I honestly do try to remain civil with others. But I'm one click away from saying screw it and just walking away from all of this chaos. My intentions are honorable, my knowledge of the subject matter reachs an expert level, and yet the articles (as well as I) are now under constant attack. Guess thats just the way wikipedia works. But it definately gets to be quite discouraging at times.

For example one editor deleted an entire section on the avelox article dealing with legal issues. Rather than rewriting the section. Claiming that noting that the legal community had shown an interest in soliciting clients who had been injured by avelox was a blatant advertisement for a law firm. Even though no law firm was even mentioned. The fact that avelox is being considered for multi district litigation as a defective product by a significant number of law firms is notable. Particularly when you take into consideration the litigation surrounding the other drugs found within this class. As such this information would be relevant under the legal status heading. Instead of rewriting it this editor decided to simply throw it away. How do you address that without starting an editing war? In other quinolone articles I have found that damning references have been deleted completely and subsituted with nonsensible ones. How do you fight that? As such I am seriously wondering if it is even worth the effort here as everybody seems to be hell bent on reducing the articles to the useless rubble they were before I even began.Davidtfull (talk) 13:42, 17 July 2009 (UTC)


 * This is complicated – I will try and post a suitable answer tomorrow. Also to your time line proposal. --ἀνυπόδητος (talk) 21:31, 18 July 2009 (UTC)


 * Obviously, you are learning the hard way... Editing articles about which one has strong feelings isn't easy at the best of times, and starting this way is practically impossible without unintentionally offending people. The reason why some think there is something underhanded taking place (and I am taking your word for it) is that underhanded things often run like this: A new and obviously unpractised editor specialises on a topic and adds kilobytes of biased looking material, mostly on religious, national or medical topics ("The Telescope Would Not Have Been Possible Without The Aid Of The Islam", "The Mbutututa Are A Separate Nationality And Not Part Of The Mbatutata", "Vaccines Kill Your Children, So Buy Our Homoeopathic Vaccines", and I am exaggerating only slightly). Do not get me wrong: I am quite sure that you are not doing this sort of thing, but it is hard to tell for editors, and so they draw conclusions.
 * So, Wikipedia works this way, but only under certain circumstances. This is good and necessary because it protects the encyclopaedia. Only, sometimes it hits the wrong people. I don't know whether this helps you in any way, I just wanted to show you the other side.
 * As for edit wars: If you undo removal of content, that's not edit warring. If the one removing the content reverts again, and talking to them doesn't help, there is Third opinion, for a start; and other places as well if that doesn't help. --ἀνυπόδητος (talk) 20:09, 19 July 2009 (UTC)
 * P.S. My apologies for not responding to the time lines issue. I'd have to read the whole talk on this topic before being able to give an opinion, and I haven't got the time at the moment. Please feel free to ask me again if you have any questions. --ἀνυπόδητος (talk) 20:14, 19 July 2009 (UTC)

No doubt I am learning a lot of things the hard way from lack of experience. Lessons learned in this fashion are not soon forgotten. Guess this is what is required to become a decent editor. So I will pay my dues and learn my lessons well here. But I am allowed to bitch about it now and then am I not when I am discouraged by the process?:)

No apology needed regarding getting to the time line issues. Do so in your own time. I was just trying to keep you in the loop as you have shown an interest in the articles and I value your input as well. I think there is a lot I may learn from you regarding proper editing here. Davidtfull (talk) 04:28, 20 July 2009 (UTC)

I have started doing some work to the quinolone articles now. I think these issues can be resolved with a bit of effort. :) We did it before on the adverse effects of quinolones article, so I see no reason why we can't do it again.-- Literature geek |  T@1k?  18:55, 20 July 2009 (UTC)

Levaquin
I've responded on my talk page. Let's keep the discussion in one place. Doctorfluffy (wanna get fluffed?) 06:51, 10 July 2009 (UTC)

Thanks, and update
Thanks for your help with the broken links at User:MastCell/FDA links. I don't know whether WP:MED is on your watchlist, but I've posted a progress report there that may interest you. WhatamIdoing (talk) 17:51, 28 July 2009 (UTC)

Norfloxacin
Hi David, I noticed recently that the norfloxacin article is particularly short on info and sections. For such a commonly prescribed fluoroquinolone it could do with some work on it, there are no interactions section, pharmacology, mechanism of action etc etc. All it has is an adverse reactions section. If you are busy then not to worry, just giving you a "heads up".-- Literature geek |  T@1k?  08:57, 29 August 2009 (UTC)


 * Just taking a break while you finished with the peer review and edits of the quinolone articles we had already started. Once we have those sorted out I intended to work on the rest.  I just thought it best to wait until you finished with your edits of the current articles before turning my attention to the other ones.  On a side note this again is yet another antique quinolone (noroxin aka norfloxacin) first approved by the FDA in 1986, and like ciprofloxacin there is no data on the FDA site for this drug between 1986 and 1994.  And the NDA is not available.  So there is going to be very little to work with when it comes to updating the article.  I would be shocked if this was still in use, let alone considered to be a commonly prescribed quinolone, here in the States.Davidtfull (talk) 17:38, 30 August 2009 (UTC)


 * Ok, that is fine but it may take me some time before I am finished with the quinolone articles, like 2 or 3 months. You can write up a basic article, like interactions, pharmacology, improve adverse reactions section if necessary and when appropriate use an article which is on fluoroquinolones in general. You can get info from pubmed and similar. Information from other countries if you have it can be used instead of USA data without a problem. It may not be commonly prescribed in USA but it is still prescribed in other countries such as Canada. It is available in the following english speaking countries under the following brand names.


 * Norfloxacin,
 * Australia: Insensye, Norflohexal, Noroxin, Nufloxib, Roxin.
 * Canada: Apo-Norflox, Noroxin.
 * New Zealand: Noroxin.
 * South Africa: Floxin, Noroxin, Utin.
 * United Kingdom: Utinor.
 * United States: Noroxin.


 * Regards.-- Literature geek |  T@1k?  22:11, 30 August 2009 (UTC)

I don't think we have had one patient over the past ten years that had reported taking norfloxacin which is why I was so suprised that you considered this to be a common quinolone. But then again there was another editor who thought floxin was a common quinolone as well, even though it had been discontinued. Anyhow this is the total content of the existing quinolone articles we have not worked on yet. As you can see most of the articles consist of one or two sentences at most or perhaps a paragraph or two. So it is rather difficult to determine which ones should be worked on next as they are all in desperate need of attention, not to mention that more than half of these drugs on this list have been discontinued or removed from clinical use:

1st Generation:

Cinoxacin is a quinolone antibiotic used primarily to treat urinary tract infections.

Flumequine is a quinolone, a first generation broad spectrum antibiotic often used in veterinarian medicine for the treatment of enteric infections. It is occasionally used in human medicine to treat urinary tract infections.

Nalidixic acid (tradenames Neggram, Wintomylon and WIN-18320) is the first of the synthetic quinolone antibiotics. Synthetic quinolone antibiotics were discovered as a byproduct of quinine manufacture in the 1960s. Nalidixic acid is effective against both gram-positive and gram-negative bacteria. In lower concentrations, it acts in a bacteriostatic manner; that is, it inhibits growth and reproduction. In higher concentrations, it is bactericidal, meaning that it kills bacteria instead of merely inhibiting their growth. It is especially used in treating urinary tract infections, caused, for example, by Escherichia coli, Proteus, Shigella, Enterobacter, and Klebsiella.. It is also a tool in studies as a regulation of bacterial division. It selectively and reversibly blocks DNA replication in susceptible bacteria. Nalidixic acid and related antibiotics inhibit a subunit of DNA gyrase and induce formation of relaxation complex analogue. It also inhibits the nicking dosing activity on the subunit of DNA gyrase that release the positive binding stress on on the supercoiled DNA. Adverse effects: Convulsions and hyperglycaemia. (this article needs considerable work)

Oxolinic acid is a quinolone antibiotic. Dosages 12-20mg/kg orally administered for five to ten days. The antibiotic works by inhibiting the enzyme DNA-gyrase. It also acts as a dopamine reuptake inhibitor and has stimulant effects in mice.

Piromidic acid is a quinolone.

Rosoxacin (also known as acrosoxacin, tradename Eradacil) is a quinolone antibiotic indicated for the treatment of urinary tract infections and certain sexually transmitted diseases. Rosoxacin is not available in the United States. It was developed by Sanofi-Synthelabo (now part of sanofi-aventis). It is classified as first generation.

2nd Generation:

Ciprofloxacin (well documented)

Enoxacin (sold under the following trade names Almitil, Bactidan, Bactidron, Comprecin, Enoksetin, Enoxen, Enroxil, Enoxin, Enoxor, Flumark, Penetrex, Gyramid, Vinone) is an oral broad-spectrum fluoroquinolone antibacterial agent used in the treatment of urinary tract infections and gonorrhea. It is no longer available in the United States.

Fleroxacin is a quinolone. It is sold under the brand names Quinodis and Megalocin.

Lomefloxacin hydrochloride (sold under the following brand names in English speaking countries Maxaquin, Okacyn, Uniquin), is a fluoroquinolone antibiotic, used to treat bacterial infections including bronchitis and urinary tract infections. It is also used to prevent urinary tract infections prior to surgery. It is taken orally, usually daily for 10-14 days. October 2008 the FDA added the following Black Box Warning to the product insert for Maxaquin: WARNING: Fluoroquinolones, including Maxaquin, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants (See WARNINGS). To reduce the development of drug-resistant bacteria and maintain the effectiveness of Maxaquin and other antibacterial drugs, Maxaquin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria'. Lomefloxacin is unique in that it forms a magnesium chelate with itself. The chelate is formed between the 2-carbonyl group of two separate lomefloxacin molecules. (this article needs considerable work)

Nadifloxacin (INN, brand names Acuatim, Nadiflox, Nadoxin, Nadixa) is a topical fluoroquinolone antibiotic for the treatment of acne vulgaris. It is also used to treat bacterial skin infections. In patients with skin lesions, topical application of nadifloxacin can result in plasma concentrations of 1 to 3 ng/ml. Consequently, it has been argued that it should not be used to treat relatively harmless diseases like acne vulgaris, risking the development of quinolone resistances. Antibacterial spectrum In vitro studies of nadifloxacin showed potent and broad-spectrum antibacterial activity against aerobic Gram-positive, Gram-negative and anaerobic bacteria, including Propionibacterium acnes and Staphylococcus epidermidis. Nadifloxacin showed potent antibacterial activity against methicillin-resistant Staphylococcus aureus (MRSA), which was similar to potency against methicillin-sensitive Staphylococcus aureus (MSSA). The drug was also active against new quinolone-resistant MRSA. Nadifloxacin does not show cross-resistance with other new quinolones. Mechanism of action Nadifloxacin inhibits the enzyme DNA gyrase that is involved in bacterial DNA synthesis and replication, thus inhibiting the bacterial multiplication. Pharmacokinetics Following a single topical application of 10gm nadifloxacin 1% cream to normal human back skin, the highest plasma concentration was determined to be 107ng./ml with an elimination half-life of 19.4 hours. Approximately 0.09% of the administered dose was excreted in the urine over 48 hours post- dosing. The plasma concentration reached a steady state on Day 5 of repeated administration study when nadifloxacin 1% cream was applied at 5 gm twice daily to normal healthy individuals for a period of 7 days. The plasma concentration reached a peak of 4.1 ng/ml at 8 hours post-final dosing with an elimination half-Life of 23.2 hours. The urinary excretion rate reached 0.16% on Day 7. (this article needs considerable work)

Norfloxacin, sold in English speaking countries under the following brand names, Apo-Norflox, Chibroxin, Floxin, Insensye, Norflohexal, Noroxin, Norfocin, Nufloxib, Roxin, Utin and Utinor is an oral broad-spectrum fluoroquinolone antibacterial agent used in the treatment of urinary tract infections. It is also sometimes used to treat stomach infections. Adverse effects See also: Adverse effects of fluoroquinolones Fluoroquinolones are generally well tolerated with most side effects being mild and serious adverse effects being rare. Some of the serious adverse effects which occur more commonly with fluoroquinolones than with other antibiotic drug classes include CNS and tendon toxicity. The currently marketed quinolones have safety profiles similar to that of other antimicrobial classes. The serious events may occur with therapeutic or with acute overdose. At therapeutic doses they include: central nervous system toxicity, cardiovascular toxicity, tendon / articular toxicity, and rarely hepatic toxicity. Events that may occur in acute overdose are rare and include: renal failure and seizure. Children and the elderly are at greater risk. Adverse reactions may manifest during, as well as after fluoroquinolone therapy. Acute pancreatitis has been reported as a rare but serious adverse reaction of norfloxacin. Some groups refer to these adverse events as "fluoroquinolone toxicity". These groups of people claim to have suffered serious long term harm to their health from using fluoroquinolones. This has led to a class action lawsuit by people harmed by the use of fluoroquinolones as well as action by the consumer advocate group Public Citizen.[9][10] Partly as a result of the efforts of Public Citizen the FDA ordered a black box warnings on all fluoroquinolones advising consumers of the possible toxic effects of fluoroquinolones on tendons. Mechanism of action The mechanism of action of norfloxacin involves inhibition of the A subunit of bacterial DNA gyrase, an enzyme which is essential for DNA replication. (this article needs considerable work)

Ofloxacin (well documented)

Pefloxacin (well documented)

Rufloxacin is a quinolone. It is sold under the brand names, Ruflox, Monos, Qari, Tebraxin, Uroflox, Uroclar.

3rd Generation:

Balofloxacin (INN) is a quinolone antibiotic. It is sold under the brand name Q-Roxin in Korea.

Gatifloxacin sold under the brand names Gatiflo, Tequin and Zymar, is an antibiotic of the fourth-generation fluoroquinolone family, that like other members of that family, inhibits the bacterial enzymes DNA gyrase and topoisomerase IV. Bristol-Myers Squibb introduced Gatifloxacin in 1999 under the proprietary name Tequin for the treatment of respiratory tract infections, having licensed the medication from Kyorin Pharmaceutical Company of Japan. Allergan produces an eye-drop formulation called Zymar. In many countries, gatifloxacin is also available as tablets and in various aqueous solutions for intravenous therapy. Side-effects and removal from the market A Canadian study published in the New England Journal of Medicine in March 2006 claims Tequin can have "life threatening" side effects including serious diabetes. An editorial by Dr. Jerry Gurwitz in the same issue called for the Food and Drug Administration (FDA) to consider giving Tequin a black box warning. This editorial followed distribution of a letter dated February 15 by Bristol-Myers Squibb to health care providers indicating action taken with the FDA to strengthen warnings for the medication. Subsequently it was reported on May 1, 2006 that Bristol-Myers Squibb would stop manufacture of Tequin, end sales of the drug after existing stockpiles were exhausted, and return all rights to Kyorin. Other serious side effects reported with gatifloxacin include hallucinations or liver damage. Contraindications Diabetes Availability Gatifloxacin is currently available only in the US and Canada as an ophthalmic solution. In India it is sold in tablet as well as in eye drop formulations. (this article needs considerable work)

Grepafloxacin hydrochloride (trade name Raxar, Glaxo Wellcome) is an oral broad-spectrum quinoline antibacterial agent used to treat bacterial infections. Grepafloxacin was withdrawn in the United States owing to its side effect of lengthening the QT interval on the electrocardiogram, leading to cardiac events and sudden death. (this article needs considerable work)

Levofloxacin (well documented)

Moxifloxacin (well documented)

Pazufloxacin (INN) is a quinolone. It is sold in Japan under the brand names Pasil and Pazucross.

Sparfloxacin (spar FLOX a sin), trade names Zagam and Zagam Respipac, is a fluoroquinolone antibiotic used in the treatment of bacterial infections. Zagam is no longer available in the United States. (this article needs considerable work)

Temafloxacin (marketed by Abbott Laboratories as Omniflox), is a fluoroquinolone antibiotic drug which was withdrawn from sale in the U.S. shortly after its approval in 1992 because of serious adverse reactions resulting in three deaths. Omniflox was approved to treat lower respiratory tract infections, genital and urinary infections like prostatitis, and skin infections in the U.S. by the Food and Drug Administration in January 1992. Severe adverse reactions, including allergic reactions and hemolytic anemia, developed in about fifty patients during the first four months of its use, leading to three patient deaths. Abbott withdrew the drug from sale in June 1992. (this article needs considerable work)

Tosufloxacin is a fluoroquinolone antibiotic. It is sold in Japan under the brand name Ozex.

4th Generation:

Clinafloxacin (INN) is a quinolone antibiotic.

Gemifloxacin mesylate (trade name Factive, Oscient Pharmaceuticals) is an oral broad-spectrum quinolone antibacterial agent used in the treatment of acute bacterial exacerbation of chronic bronchitis and mild-to-moderate pneumonia. Oscient Pharmaceuticals has licensed the active ingredient from LG Life Sciences of Korea. (this article needs considerable work)

Sitafloxacin (INN; also called DU-6859a) is a fluoroquinolone antibiotic that shows promise in the treatment of Buruli ulcer. The molecule was identified by Daiichi Sankyo Co., which brought ofloxacin and levofloxacin to the market. Sitafloxacin is currently marketed in Japan by Daiichi Sankyo under the tradename Gracevit. (this article needs considerable work)

Trovafloxacin (sold as Trovan by Pfizer and Turvel by Laboratorios Almirall) is a broad spectrum antibiotic that inhibits the uncoiling of supercoiled DNA in various bacteria by blocking the activity of DNA gyrase and topoisomerase IV.[1] It was withdrawn from the market due to the risk of hepatotoxicity. It had better gram-positive bacterial coverage and less gram-negative coverage than the previous fluoroquinolones. (this article needs considerable work)

Prulifloxacin (INN, codenamed NM441 and AF 3012; trade names Chinoplus, Keraflox, Quisnon, Unidrox and Sword) is a broad-spectrum fluoroquinolone antibiotic. It is a prodrug, and is metabolized in the body to the active compound ulifloxacin (also known as AF 3013). Prulifloxacin has a long half-life and may therefore be taken only once a day. In clinical trials, prulifloxacin appeared as effective as ciprofloxacin, co-amoxiclav or pefloxacin in the treatment of bronchitis exacerbations or lower urinary tract infections. It was tolerated as well as ciprofloxacin. Prulifloxacin has been approved for use in Japan. In the United States, it is undergoing phase III clinical trials for the treatment of traveler's diarrhea. (this article needs considerable work)

In development:

Garenoxacin (INN) is a quinolone antibiotic for the treatment of gram-positive and gram-negative bacterial infections. It was discovered by Toyama Chemical Co., Ltd. of Tokyo, Japan, and is currently being marketed in Japan under the tradename Geninax. Schering-Plough holds worldwide rights for garenoxacin, except for Japan, South Korea, and China. On February 13, 2006, Schering-Plough announced that the United States Food and Drug Administration has accepted the New Drug Application (NDA) for garenoxacin, and has been granted a 10-month review. Schering-Plough later withdrew its application to the United States Food and Drug Administration, FDA, (August 20, 2006) for approval of the antibiotic Garenoxacin. The European Medicines Agency (EMEA) had also been formally notified by Schering-Plough Europe (July 28 2007) of its decision to withdraw the application for a centralized marketing authorization for Garenoxacin as well. Based on the CHMP review of the data regarding safety and efficacy, (risk/benefit) the CHMP considered the application for Garenoxacin to be unapprovable.

Delafloxacin (originally RX-3341) is a fluoroquinolone antibiotic being developed by Rib-x Pharmaceutical inc. It is more active (lower MIC90) than other quinolones against Gram-positive bacteria such as MRSA. Phase II clinical trials have reported good results for example compared with tigecycline

So as you can see just about every quinolone article, that we have not addressed, needs extensive work to bring them up to speed. There is tons of work to be done here if we were to fix all of these articles. Perhaps the other editors who have been monitoring our efforts could begin work on some of these as well. And there are still a number of fluoroquinolone drugs that have not even found there way onto wikipedia as of yet, so they don't even have any articles written at all.Davidtfull (talk) 07:20, 31 August 2009 (UTC)

I just assumed that norfloxacin would be fairly commonly prescribed, not as much as ciprofloxacin and levofloxacin but I guess I am probably wrong. A lot of those other quinolones that you listed are only used in veterinary medicine I think and also some have been discontinued or are rarely used except in a handful of non-english speaking countries and are not as important. BTW I stumbled across article which may interest you.-- Literature geek |  T@1k?  14:30, 31 August 2009 (UTC)


 * Perhaps norfloxacin is used more frequently overseas which would justify your assumption, and rarely here in the States which would justify mine. The big three here seems to be Levaquin, Cipro and Avelox; which leaves the rest of the quinolones in the dust.  Just goes to show the stranglehold that big pharma has here when it comes to prescription drugs.


 * The link to the pubmed article you thought I would have an interest in did not work. Were you by chance refering to this article?


 * http://www.ncbi.nlm.nih.gov/pubmed/18647180


 * On a side note your link had a "this" on the end which may have been an inadvertent typo. If so, then just to give you a heads up benign intracranial hypertension has been well documented as being yet another overlooked adverse reaction to these drugs.  Davidtfull (talk) 00:06, 1 September 2009 (UTC)

Nitrofurantoin
Out of interest a doctor mentioned that nitrofurantoin is similar to quinolones? I do not know whether he meant target organisms such as gram negative or whether the doctor meant toxicity and chemical/molecular make up of the drug. Is it a derivative of quinolones? Any issues with it? I know a girl who had a bad reaction to it is why I am asking.-- Literature geek |  T@1k?  22:30, 30 August 2009 (UTC)


 * That is a very OLD drug, you are going all the way back to 1953 here and the original oral form had been discontinued a long time ago (1998). It has no relationship whatsoever to the fluoroquinolone class.  However the generic IV solution is still available, as well as generic tablet forms of Macrobid (Nitrofurantoin; Nitrofurantoin, Macrocrystalline) .  Acute, subacute, or chronic pulmonary reactions are quite possible with this drug as well as serious and life threatening hepatic reactions, both of which may result in the death of the patient.  Peripheral neuropathy, hemolytic anemia as well as Stevens-Johnson syndrome is also associated with its use not to mention C difficulty.  Perhaps this serious safety profile is what the doctor was referring to as being similar to the quinolones.  But chemically speaking they have nothing in common.Davidtfull (talk) 05:57, 31 August 2009 (UTC)


 * Thanks for the info, very useful. Have you heard of anyone experiencing bad adverse effects from it before? Ever heard of CNS effects from taking it? Would you consider it as hazardous as quinolones?-- Literature geek |  T@1k?  14:33, 31 August 2009 (UTC)

The first I had heard of this drug is when you brought it to my attention, so I really can't address the concerns you had raised. Within the package insert however it is stated that "Benign intracranial hypertension (pseudotumor cerebri), confusion, depression, optic neuritis, and psychotic reactions have been reported..." I would not put it on par with the quinolones, as the quinolones have a far greater range of severe adverse reactions associated with their use. I would say this would be similar to the safety profile you find with most other toxic antibiotics, in my opinion. It appears to trash the gut, the nerves and the liver. Not to mention possible cardiac complications. So I would agree this is a dangerous antibiotic which would require close observation of the patient. But no, I would not consider it to be as hazardous as the quinolones; based upon what little information I could uncover regarding it. But opinions can change as more facts become available. :) Davidtfull (talk) 00:18, 1 September 2009 (UTC)

Diplopia
Hi David, did the study find reports of permanent diplopia? I only have access to the abstract. Fvasconcellos (t·c) 20:14, 5 September 2009 (UTC)


 * Which study are you referring to here? There are three different ones to be found on pub med regarding diplopia and the quinolones.  The latest being the one written by the Fraunfelder's (father and son) to wit:


 * Ophthalmology. 2009 Sep;116(9):1814-7. Epub 2009 Jul 30.
 * Diplopia and fluoroquinolones.Fraunfelder FW, Fraunfelder FT.
 * Department of Ophthalmology (Casey Eye Institute), Oregon Health & Science University, 3375 SW Terwilliger Blvd., Portland, OR 97239, USA. eyedrug@ohsu.edu PMID: 19643481 [PubMed - in process]


 * I would imagine that the latest would state permanent diplopia as I am one of the many reports to be found within the FDA database, and I have suffered from this for over a decade now. As such I would consider it to be permanent.  (And have filed a report every year since 2000 as well) Going from 20/20 with no need of glasses to trifocals with prisms.  And when the latest prisms fail I will require a patch over one eye.  I have also had discussions with the Fraunfelder's back in 2004 regarding this reaction and had furnished them with a database of well over three hundred members who had suffered vision damage, including permanent and transient diplopia, as a result of fluoroquinolone therapy.Davidtfull (talk) 23:55, 5 September 2009 (UTC)
 * I did mean the Fraunfelder study. Very sorry to hear that—I didn't know you'd been personally affected by this. Fvasconcellos (t·c) 01:55, 7 September 2009 (UTC)

The full text is available using this link, but only to registered users:

http://www.ophsource.org/periodicals/ophtha/article/S0161-6420(09)00655-1/abstract

It was also published in the September issue of Opthalmology,the journal of the American Academy of Ophthalmology (Academy), so I think you should be able to obtain a copy of that journal as well. Here is the contact information for the publisher:

Elsevier 360 Park Avenue South New York, NY 10010 Tel: 212-633-3887 • Fax: 212-633-3913 Davidtfull (talk) 04:04, 7 September 2009 (UTC)

editing disputes
Hello and welcome to wiki. I know I'm a bit late saying that but i saw your comments on pharmaclogy talk. I have no idea what difficulties you have had and am not going to spend a year looking up the posts, but I just wanted to observe that this is unfortunately common. Anyone deciding to edit any article even slightly controversial is likely to meet editors who disagree. References on wikipedia are used as a means of waging war. I think people choose to do this because the alternative is simply to wage war without references, and having the outside opinion expressed in refs helps others choose sides. Most editors are not experts on any particular subject and it can be very hard to judge whether some plausible text is in fact correct. The existence of refs frequently gives only a superficial guarantee of accuracy, because who has the time to check and assess them? From the opposite side, when you are an expert but others disagree, it can be very frustrating when they dispute statements which seem perfectly obvious. There is a famous case where someone proved political parties were editing 'george Bush'. Surprise, surprise, but don't be amazed if some people are hard to convince. As to the rules people have written to try to partrol wiki editing, someone must be going to start a degree course in them soon.

I have observed that wiki has become increasingly unfriendly to newcomers over the years. I console myself that at least in part this is because it now has bigger better articles and the balance has shifted somewhat from hoping someone knowledgeable will come along and write something to defending an existing reasonable collection of article from vandalism. Peoples mindset becomes resistant to change. Sometimes though, you come across some sentence of total rubbish which has miraculously survived in an article ever since it was started.

Don't know if that is encouraging or discouraging, but you seem to have chosen a tough place to start. perfection is not a thing which comes easily on wiki. Truth is not an official goal. Sandpiper (talk) 09:23, 8 September 2009 (UTC)


 * Appreciate the words of encouragement. Yeah I most definitely stepped in it here, but as you say that's the nature of the beast.  I'll survive somehow.  I've learned a long time ago not to take such things personally by any means.  Baffling is that there is absolutely no reason, or justification, for some folks to be so harsh.  This is what I fail to understand.  OK, someone disagrees with something in an article, which is to be expected.  No big deal.  So why start a war over it?  Why not state the reasons you disagree with the content, have a rational and reasonable discussion regarding it, and then make the necessary changes?  It is not the suggested changes I have had a problem with over the past six months, it is the asinine arrogance and the "holier than thou" crap that seems to go along with them.  Makes a person want to be difficult and ornery just because they resent being bullied.  And if there is one thing I absolutely despise, it is a bully.  I will go toe to toe with a bully any day without a second thought and no regrets.  Whereas I am more than willing to compromise with a reasonable person and let them prevail.  Somehow I think we now have more bully’s here than reasonable people.  Comforting to know that I am not the only one that noticed this.  Thanks for taking the time to comment.  :)Davidtfull (talk) 23:07, 8 September 2009 (UTC)
 * I have noticed some editors who have a history entirely devoted to article maintenance, thousands of edits very fast who then become admins on the basis of their devotion to running things. I don't beleve it used to work quite like that. There is an argument for letting people who like to run things do the running of things, but there seems a danger that either someone somewhere is making a power grab, or just a split between those supposed to be helping editors and the editors themselves. I have quite often seen one set writing rules about how to do things totally at variance with how most of the editors concerned naturally go about it. Some people have become quite arrogant.  I think you answered your own question though, about why start a war: you will fight bullies, someone else will fight something else...and on we go. Sandpiper (talk)

We all know it to be a proven fact that anything designed by committee is doomed to complete and utter failure. So I try not to take the politics of wikipedia too seriously here. The way I see it is if it was good enough for the Ingenious Hidalgo Don Quixote of La Mancha to tilt at windmills and remain the butt of others jokes, no reason why I can't do the same while toiling away on wikipedia (while trying desperately not to tweak the noses of the anal retentive deletionist crowd). I'm not endentured here and when I have had my fill I can always just ride away into the sunset having left my mark. Nothing ventured, nothing gained. After all everybody's opinion here is nothing more than magnetic ink to begin with. Easily erased on a whim. Enjoyed the discourse and wish you well. :) Davidtfull (talk) 21:26, 9 September 2009 (UTC)

Quinolones and MRSA
David are you aware that colonisation with MRSA is most highly associated with quinolones compared to other antibiotic classes? Doc James found a Systematic review and meta-analysis and I found guidelines which state the widespread use of quinolones needs curtailed to reduce MRSA infections. I am surprised you haven't edited it into articles as it is very significant at least over here in the UK where MRSA infections are a major political as well health issue and I imagine it is similar in other countries. Check the main quinolone article, I added it to the lede/intro. What are your thoughts of adding it to other quinolone articles? We need to start adding more of these good quality secondary sources and cutting down on old primary studies. Let me know your thoughts.-- Literature geek |  T@1k?  20:55, 16 November 2009 (UTC)


 * We've had any number of members report experiencing MRSA infections over the years on the forums. After the hassles we got regarding C difficulty infections I saw no need to rock the boat further by adding this in. My thoughts were to just add it in down the road when the spot light had shifted elsewhere.  But if you wish to add it in now I have no objections.  There has been so many secondary sources coming on line recently that I am years behind in adding them to the research site.  In fact on Pub Med alone the number of quinolone articles have doubled from 11,497 in 2004 (1982-2004) to 29957 medical journal entries to be found today.  As such this has more than doubled over the past five years and I just simply haven't gotten that far yet.  :)  Davidtfull (talk) 01:36, 18 November 2009 (UTC)


 * Thanks for getting back to me. If I remember correctly the C Difficile was cited to a case series. If sourced to a recent secondary sources there shouldn't be any problems. That was how I resolved that dispute, your edits on C diff were accurate just not sourced to best available sources. If weak sources are used then they are more likely and can be challenged, per WP:MEDRS. I am going to concentrate on the main quinolone article over the next few days and then go back to the other quinolone articles and add it then. From putting in fluoroquinolones into pubmed and then clicking on the review section there appears to be about 700 articles from the year 2004 to now. Idealy secondary sources should be 5 years or less old, but if they are within 10 years old they are usually ok with other editors in my experience unless you are working on a featured article. Although certain aspects of articles need to be more strictly with sources, eg in case of antibiotics with changing bacterial sensitivity WP:MEDRS would need to be followed more strictly when discussing therapeutic indications. On another point, the contraindications section in the main quinolone article is severely lacking and needs expanding.-- Literature geek |  T@1k?  06:59, 18 November 2009 (UTC)

Hi David. I have finished the quinolone article. Refs are inline citations now, merged risk-benefit section into indications section, removed uncited text and reworded unencyclopedic wording as well as other household tidying. I think that the article is looking much better now. What do you think? There is only one area which needs attention and that is the contraindications section, that as you know is a very important section. I think that the quinolone articles are in much better shape now.-- Literature geek |  T@1k?  12:15, 22 November 2009 (UTC)


 * Will take a look at the articles in a week or two. My mother is in the hospital at the moment and will more than likely end up in a nursing home when they discharge her.  So dealing with her is going to take up a lot of my time as she lives 1500 miles away from me and I have to handle all of this over the phone.Davidtfull (talk) 03:16, 26 November 2009 (UTC)


 * Ok David, no rush. I expanded the contraindications section anyway. I am sorry that your mother is not doing well and I hope and pray things improve for her. Best wishes. :)-- Literature geek |  T@1k?  20:21, 27 November 2009 (UTC)