Talk:Isotretinoin/Archive 1

Dosage
does anyone have any more info on the efficacy of a lower dosage and Roche's recommended higher dosage mentioned in the article (clincal trials, possibly)? this seems a little bit strange, and i have not heard of this from my derma or anyone else.

More info:

--- START ABSTRACT ---

Background

The efficacy of isotretinoin at 0.5 to 1.0 mg/kg per day in the treatment of acne is well established and considered safe, although it is sometimes not easily tolerated because of its cutaneous side effects.

Objective

The purpose of this study was to determine the efficacy of low-dose isotretinoin in the treatment of acne.

Methods

In this prospective, noncomparative, open-label study, 638 patients, both male and female, with moderate acne were enrolled and treated with isotretinoin at 20 mg/d (approximately 0.3-0.4 mg/kg per day) for 6 months. The patients were divided into two age groups: 12 to 20 and 21 to 35 years old. Patients were evaluated at 2-month intervals by means of clinical and laboratory examinations. A 4-year follow-up was also carried out.

Results

At the end of the treatment phase, good results were observed in 94.8% of the patients aged 12 to 20 years, and in 92.6% of the patients aged 21 to 35 years. Failure of the treatment occurred in 5.2% and 7.4% of the two groups, respectively. Twenty-one patients dropped out of the study because of lack of compliance, and another patient discontinued participation because of a laboratory side effect. During the 4-year follow-up period, relapses of the acne occurred in 3.9% of the patients aged 12 to 20 years and in 5.9% of the patients aged 21 to 35 years. Elevated serum lipid levels (up to 20% higher than the upper limit of normal value) were found in 4.2% of the patients and abnormal (<twice the upper limit of normal values) liver tests were observed in 4.8%.

Limitations

This was a noncomparative, open-label study.

Conclusion

Six months of treatment with low-dose isotretinoin (20 mg/d) was found to be effective in the treatment of moderate acne, with a low incidence of severe side effects and at a lower cost than higher doses.

--- END ABSTRACT ---

More experiments/studies involving low dosage treatment:

http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=pubmed&dopt=AbstractPlus&list_uids=9764156

http://www.uspharmacist.com/oldformat.asp?url=newlook/files/Feat/apr00iso.cfm&pub_id=8&article_id=508

http://archderm.ama-assn.org/cgi/content/abstract/130/3/319

http://www.blackwell-synergy.com/doi/abs/10.1111/j.1365-4362.1994.tb01500.x

http://www.blackwell-synergy.com/doi/abs/10.1111/j.1365-4362.1994.tb01500.x

http://www.blackwell-synergy.com/doi/abs/10.1111/j.1468-3083.1998.tb00763.x

http://content.karger.com/ProdukteDB/produkte.asp?Aktion=ShowFulltext&ProduktNr=223854&Ausgabe=227284&ArtikelNr=45270

Marijuana use
The page claims that it can heighten depression, yet doesn't source it. Depression is an extremely serious mental condition. It doesn't make sense to suggest that something really bad is more likely to happen, but then not cite it. The whole comment should be removed. It causes needless fear. 24.86.144.101 06:48, 15 June 2007 (UTC)jvp
 * http://depression.about.com/gi/dynamic/offsite.htm?site=http://www.pslgroup.com/dg/5d8e2.htm
 * cite it if you want. It's not some little tidbit of knowledge, it's on every manufacturers website and on the prescription box. I also think it's 'may' and not 'can'. Companies don't like side-effects.

Statistics on effectiveness
Are there any statistics on how often it helps its patients etc? I once heard 80% of people who use accutane are cured of most acne or whatever.

Listing in google
I have a feeling the drug box is negatively affecting this pages rank in google. I think google is denying it a description because of it. I'm going to move it below the opening paragraph in order to try and remedy this.--Jaguar2k 10:43, 4 Mar 2005 (UTC)

Fact Check
I think the history needs some more referencing and fact checking as some of it doesn't seem to add up and is very general.

A well sourced article: http://leda.law.harvard.edu/leda/data/472/Green.html

It may be worth appropriating some of the information there to this article or looking up those sources.

Also, some of the content seems to repeat itself too (I think the same info about birth defects is mentioned twice).

"Death" as a possible side effect..? that is totally ridiculous. Absolutely false.

REPLY: I completely agree. Just stating "death" as a side effect simply won't do. You need to at least say what causes the "death". If this is in regards to the possible links to depression and suicide, then it's completely unnecessary. In fact, this should only remain in the article if the person who entered it can cite evidence of a case where somebody has died from taking Isotretinoin and it has been PROVEN that the drug is the cause. As it is, I think it's only going to serve as a needless scare for those who may be about to begin a dose of the drug.

Personal Experience
I am currently on the Drug and of all the symptoms listed I have experiance dry lips (constantly). Also my skin is becoming more brown, I have not noticed any of the other side effects.

My specialist has told me that birth defects are only apparent for preganant women. In Australia women are not prescribed the drug without being on the pill.

I was also curious about the psycological effects. I have been informed that there has been no proven link with depression and suicide allthough there have been some studies to suggest that it is so.

Dry lips is a very common side-effect (almost universal, from what I know). Most of the side-effects, however, are potential ones, afaik.

I've been on it for like a week, and I've been getting hit with these very short bursts of depression, where I'll just feel totally dejected and lackadaisacal for 10 minutes or so, so I just distract myself by reading, then it goes away. Really very bizarre, can't see it driving me to suicide though, fortunately ;)


 * "My specialist has told me that birth defects are only apparent for preganant women." Huh? Alex Dodge 06:23, 29 September 2006 (UTC)

I have 2 days left of a 6 month treatment and for all but the last week all I expirienced was dry lips and the joy of being able to face myself in the mirror. I wish I would have committed to the drug sooner. As of the last week I've noticed a lack of energy and more general dry skin, but that could be due to the colder weather. The only thing I worry about after taking the drug is my acne will return, but asfar as I can see the drug was a blessing

^I was on acutane myself a few years ago. It works great I really wish I would have gone on it sooner. I myself never experienced depression, but like you said, dry lips are a constant. My friend recently started taking it a few weeks ago and he always bitches about his dry lips, but he says it's totally worth it because it's already doing wonders for his skin.

Accutane brought me OUT of my depression. Before I started the drug, my skin looked horrible. Within days, I was cleared up. The dry lips were a small, small price to pay. Bless the discoverer of this fantastic drug.

I was on accutane for very close to a full cycle. although my acne is gone, a year since i finished, the depression i had was very noticable. i would feel bad about nothing, sitting there thinking about how nothing is going right, although i knew of no specific examples. also, my lips were quite dry and skin dry towards the end —Preceding unsigned comment added by 134.117.157.29 (talk) 03:25, 4 October 2007 (UTC)

Isotretinoin and Me
A few years ago i was diagnosed with clinical depression, although not the most severe depression, it was severe. I had resorted to self harm and suicidal thoughts and even planning. I also suffered severely with acne, and after many different courses of topical solutions and tetracyclines (which eventually the body develops a natural immunity to), i still had acne and had noticed no improvement. My sister had been on Roaccutane years before and her acne had cleared perfectly, therefore i asked the doctor if i too could go on roaccutane. ALthough he was reluctant (due to my mental state) he allowed me to go on it as i felt that through the clearing of my acne i may feel a little better.

I had to have 3 courses of roaccutane as my acne was so severe. During my time on the drug the side effects i experienced were dry skin and lips, slight redness of skin and blushing easily. Over the 2 years i was on the drug my skin improved drastically, at the end of which i was totally free of my acne. DID I MENTION?... Despite having depression, during my use of the drug i was improving mentally, i had stopped self harm and was feeling better due to the clearing of my acne.

In conclusion i am entirely grateful for Isotretinoin/ Roaccutane. Neither my sister or i commited massacres or suicide during our time on the drug, and our skin is now greatly improved. It is also important for you readers to know that we also have a family history of Schizophrenia and Depression. The drug did not cause either to occur in either of us, despite our predisposition to the mental illnesses. Overall i believe Isotretinoin should be here to stay, anyone who believes otherwise should ask those who suffer with acne, for us Roaccutane is a miracle. Ladybird1126 (talk) 14:52, 30 December 2007 (UTC)

Another case
It was revealed that Martin Bryant (Port Arthur Massacre) was also on Roaccutane at the time of his massacre/suicide, leading to depression/suicide, and in his case, stockpiling of weapons. Another interesting link is the reported but apparently not confirmed tendency for people using Roaccutane to hoard sugary sweets, due to the body trying to regulate the natural substance...


 * Are there reliable sources for this information and do you have concrete evidence that Bryant's killing spree had something to do with the psychological effects of isotretinoin? I think the evidence for the suicide/depression thesis sofar is very flimsy. Karl Stas 21:11, 11 February 2006 (UTC)

After trying all other available solutions to cure my wife's stubborn acne, she resorted to Accutane. It was extremely effective with no lingering side effects. She experienced some dry skin while on the treatment and had some slight hair thinning and hair texture change. But those problems disappeared shortly after the treatment concluded. After more than twenty (yes, 20) years, no problems have surfaced. We are the parents of two healthy, beautiful girls. Our older girl was conceived I think around seven years after the treatment, and we had no trouble conceiving. My wife is now 46 and people often remark that she looks much younger than her age. In her case, the drug produced no premature aging, which one might think could happen. The reason I am resarching Accutane now is that it appears that our older daughter is going to need it, and I am trying to research case studies just for safety's sake. I'm amazed, though, that the lawyers appear to have seized hold of the information flow about this useful drug. Yes, it is a powerful drug and, yes, birth defects are a known side effect, but the psychological "problems" I think may be blown way out of proportion. Consider this: When someone is considering Accutane, they usually have severe, disfiguring (i.e., scarring) acne. When they go through a course of treatment the acne is cured, but the scars remain. When that fact sinks in, I think it is then that the patient can possibly become suicidal. Those with over-active glands--who are acne treatment candidates--would seem likely to be predisposed to psychological issues as well, I would think. And also consider this: We are having to jump through hoops at the moment and are faced with extremely large costs (I suspect largely due to excessive litigation) to be able to get Accutante treatment for my daughter. Meanwhile, she runs the risk of scarring if we can't get treatment started in time. When my wife took it, it was a) reasonably priced and b) there was no waiting period. One last comment...it would be great if there was a place that shared really useful information on patients' experiences rather than focusing on these so-called psychological problems.


 * I didn't have any sort of mental problems prior to taking Accutane 6 years ago. During the course of the treatment I had pretty much every single symptom that Roche likes to claim doesn't happen very often. I spent 6 months on the couch sleeping, getting up only to take my pills and eat a small ammount of food before going back to bed. I'm glad that your wife didn't have any problem with it, but some people do, and not just people who are 'predisposed' to mental problems. I didn't have 'disfiguring' acne, I had pretty managable normal acne for a 18 year old, but for some reason the doctor that I went to decided that Accutane would be the best course of action, without trying anything else. The way he made it sound, it was the best stuff ever. I should have taken the hint when my lips started to crack uncontrollably without a thick layer of carmex daily. I should have taken in the hint when I started to not be able to drink liquid on an empty stomach without feeling like I was being stabbed. And I should have also taken the hint when I felt like everything I was doing was completely meaningless, because the drug made me feel that way.


 * Just because you know someone who didn't have a problem with it, doesn't give you the right to downplay all the expirences of people who HAVE had problems with it. I wish I had never taken it, since I still have some residual physical problems from it -greg.schoen@gmail{nospam}.com - 21:54 - 2 September 2006

I can only speak authoritatively on what I have seen firsthand. As I mentioned, my wife had excellent success with no lingering side effects. And now my daughter has finally been authorized to receive the drug. She has been on it 20 days as of this writing (9/6/06). The oiliness of her skin has reduced noticeably. The inflamation has gone way down. Those who haven't seen her in the last month can notice the improvement right away. As a result, she actually likes looking at the mirror now, rather than shunning it. The only side effect she has noticed is her lips are dry. She carries a $1 stick of lip balm around with her. I asked her, and she has stated firmly, that she can sense no change in her mood, other than the mood lift she is getting from her much improved complexion.

Re your own situation, it is well known that Accutane is a treatment of last resort. It's a powerful drug that should not be used for a "pretty managable (sic) normal acne". To do so is foolishly naive. And certainly there may very well be a relatively small percentage of cases that have had severe, adverse reactions. But what I am seeing is that the lawyers are attempting to crucify the drug. FYI, the bill for my gaughter's first month's supply of pills was $372. Add to that the costs of the monthly pregnancy checks, the blood work, the doctors visits, and it's now unnecessarily expensive--largely due I think to frivolous lawsuits. We should hit our deductible soon, but until we do, this is money out of my pocket. When my wife went through the treatment, the costs were very minor. I only hope that when and if my younger daughter needs to get on it, the drug hasn't been discontinued because of this litigation insanity that's going on. Imagine having to go through life with a severely scarred face, which could be prevented. It's very easy to claim that the drug makes you "feel" bad, but nothing that a little cash can't cure, right? -A Tampa Dad.

the previous post regarding your daughters case is totally legitmate. your massive sample of 2 hardly counts as an unbiased opinion. this medication has raised many concerns, therefore clearly having a basis somewhere. your short sightedness may not be harming you, but a board allowing open discussion regarding the potential dangers is a great asset. these pychological problems are real, and your patch of calling people experiencing these side effects is atrocious. your insensitivity and ignorance of people's opinions shocks me. —Preceding unsigned comment added by 134.117.157.29 (talk) 03:31, 4 October 2007 (UTC)

Depression
My best friend was perscribed Roaccutane 7 years ago. He was perfectly normal until he started taking this stuff, I'm not talking about just being sad because his Acne was giving him self-esteem issues, he had all out paranoia. We would be walking the the park, and he would be like "That guy is starting at me!" "That little girl is staring at me!" and when driving around he put the headrests back on the passenger seat because "Everyone is staring at me". He was only on it for a couple of months, but still to this day he is mildly paranoid (He is on medication) and gets the munchies/very moody if he stays up late.

The cases claiming depression arn't frivolous, this is very real. I wish there was some articles that I could source, because as rare as depression from Roaccutane is, it is still a very serious side-effect that should be considered before taking it. Don't complain that it costs $372 because suffering depression is nothing to do with money. --220.239.221.186 05:32, 15 October 2006 (UTC)

OH! CUT THE CRAP! Accutane has been a life saver for me. Every person that has felt first hand (as in directly not "a friend, relative etc") knows that THIS DRUG IS A MIRACLE. Just think about it: Wouldn't a person with digusting, hideous wounds on his/her face be more freaking likely to enter depression than a normal one? It is logical that all Isotretinoin users should have severe acne; so please take your crap somewhere else. If anything, this drug has stopped thousands of people from commiting suicide and from ending their sad, pathetic lives. PS:And let's say for a minute that it does cause severe depressions... Why would you want to live with a disfigured face anyway? and with a disgusting skin disease that has no other cure and will harm you till you are 40?22:21, 25 January 2007 (UTC)

So true. Accutane is a miracle. I only wish I had taken it sooner. I never had depression from it, I was always cheerful as I watched the effects on my face and body.

---My ex-boyfirend had very serve acne for about 4-5 years. It bothered him, and he did suffer bouts of depression regarding the acne. He began taking Accutane and his acne cleared up quite a bit. He was on the drug for about 1.5 years.However, he experienced a complete personality change. He became VERY irritable and depressed. After he stopped taking the Accutane the depression cleared, but the irritability remains to this day, 6 years later. With much counseling he is able to control the irritability most of the time, but still has issues. Though his acne is gone, he has said that he would take the acne back if it would give him back "his mind" as he puts it. So yes, while it does work and work well for most, the side effects can be devestating. Sjc80 03:07, 28 May 2007 (UTC)

(Y) I took Roaccutane for 5 months, when i started the fourth i did get clinical depression, had many suicidal thoughts that just came out of nowhere & eventually had to Cipralex (anti-depressent) for 6 months as a result. You all know how Roaccutane drys you up, it is no wonder that it also dry's to death your Serotonin Receptors which causes the depression. Nowadays i am fine, and am actually on roaccutane again for 3 weeks as my acne returned (in a much smaller scale ofcourse), this time for only 3 months. It has depression as a side effect right there on the note inside the box, so dont say its "crap" just because you didnt experience it. each of us is inchrage of his own destiny and each one has the right to decide what he want to do, but Dont deny any possible side-effects unless you have a Real base for it!

I took accutane for six months while in high school to treat very bad cystic acne. It did work, (six years later I have only a few outbreaks a year, as opposed to constant daily redness and soreness) and I would probably do it again if necessary. However, while I was on it I experienced severe depression / suicidal thoughts. I've never felt that bad ever before (usually I'm a pretty cheerful, agreeable guy). I really think that the parents / friends / loved ones of anyone taking accutane should keep a close eye on the user. That said, a couple of months after going off of accutane and I returned to my normal self. --Stvfetterly 12:42, 29 September 2007 (UTC)

I wouldn't call Roaccutane a miracle. I am currently on it, and have been so for 6 months now. Although it is starting to really clear up rapdily now, what I had to go through was almost NOT worth it. I suffered from deppresive thoughts. Most days, I didnt want to talk to anyone or even see anyone. I would just sit in my room all day. And also, the reason for most depression (and mine) is that Roaccutane actually makes the acne get worse before it gets any better. This is a common fact. It says it in the pamphlets and has been the case for everyone I know who took the drug (including myself). The fact that it gets so bad, feels kind of crappy, and in some cases gives you a really low self-esteem causes you to be depressed. The drug has also caused constant nosebleeds for me, and has given me a very bad rash all over my body. The side effects are really bad. I will be off the drug in just 1 1/2 months, which is a good thing. I never want to talk about this experience again. I just wasnt myself while I was on it. I am also known for being cheerful and full of happiness, but while Im on the drug, I dont even talk much.

Pointless secondary effects list
No matter how long or short the secondary effects list on the right or the article is, there is two large problems with it: 1.- Nowhere in the article are they mentioned, save Teratogenia and Possible Depression, and they are pointed out in the box as the serious secondary effects. Else than that... 2.- ...Nowhere in the article or the box is mentioned the frequency of these secondary effects (not even a hint like "rare" or "common").

The number of different secondary effects put into the box can be strongly misleading, it can make the reader think that those secondary effects may be common (I thought that, before reading the article, and several others elsewhere, and drawing my own conclusions). I recommend to at least put a tag in the box pointing out those secondary effects are rare, and to number the common ones in a particular section of the box.


 * At the bottom, it says that the congressman's kid was on accutane and shot himself to death. Is it really necessary to say "with his father's loaded and unlocked handgun?"


 * hope his dad doesn't read that.

So, in response to the person that posted before the last one: Yes, the drug works, but to call something a miracle and then ignore side affects is a big step. Having acne or any acne related issues is a far cry from having any of the side-affects that doctors warn their patients about when beginning Isotretinoin. It is awfully ignorant to just say that people with acne are hideous, and would probably just commit suicide anyway. Next time, if you're going to discuss something here, at least make it constructive, and take your angry, ignorant focus somewhere else.

Update
I have made the site current with information about the iPLEDGE website. Philiphughesmd 04:01, 12 April 2006 (UTC)

Infobox
I have updated this article to use the new infobox. I have similar questions about the secondary effects list -- are they truly needed? None are wikilinked, and I haven't seen any other drug articles with a similar list. I am going to post on WikiProject Drugs and see if anyone there has an opinion. -- Irixman (t) (m) 14:51, 9 June 2006 (UTC)

Cleanup
This article needs a cleanup. Things that need to be focused on:


 * General conciseness and readability.
 * Available forms (instead of a unnecessary list of brand names maybe?)
 * Using the reference system instead of external links would ne nice
 * Layout - is there any need for picture of a bag of pure isotretinoin and the accutane logo?
 * Prescribing information - In the UK (and other countries?) the course must be started by a dermatologist.
 * Side effects - maybe a list of the most common ones would be more helpful

Maybe a reworking of the sections would help. Your input would be appreciated! (feel free to edit my list). Who wants to do what?

Dakoman 18:08, 9 June 2006 (UTC)
 * I've done a cleanup and I think I've addressed most (if not all) of your points. The page could probably be improved further, but I think it's enough to remove the cleanup tag -Techelf 11:40, 10 June 2006 (UTC)


 * You've done a great job, thanks - Dakoman 21:11, 10 June 2006 (UTC)

Statistics ?
Are any statistics available on the use of Accutane ? We know 431 cases of depression have been signaled since 1982, but on how many treatments ? It can be interesting to know how widespread the use of accutane is, I can't find this information on the net.

Idiopathic Intracranial Hypertension
Does anyone else see how questionable it is to state that taking Roaccutane increases the risk of an idiopathic disease?I elliot 08:29, 21 September 2006 (UTC)

anti-cancer
I have read somewhere that Isotretinoin being researched as an anti-cancer drug. if possible, someone do a research and add it to article.

30 DAY THEORY IS INCORRECT!!!
Remove it, it's false. I was a patient on Roaccutane for 1 year and my medication was prescribed to me in doses of 90 and more. Get your damn facts right if you are going to put them on here.

Keep it, it's true!!! I don't really know why I wasn't able to get more than 30 days and you got 90, but as of start of the iPledge system I couldn't get more than 30 days worth of accutane... I missed a few days because I was on vacation when my 30 days allotment ended and getting more was a big pain.


 * What... What's going on here? Alex Dodge 09:22, 15 November 2006 (UTC)


 * The first person is an idiot. iPledge allows only 30 days worth of medication per perscription, be that 30, 60 or some other amount of pills. You must wait 30 days between prescriptions. Jutm543 21:30, 29 November 2006 (UTC)

Chemical Structure: all trans retinoic acid vs. 13-cis retinoic acid
The picture in the "box" is all trans retinoic acid. The 13,14 double bond in isotretinoin (the one closest to the acid on the far right) should be "cis" ("Z"). — Preceding unsigned comment added by 129.64.72.23 (talk)
 * Fixed. Fvasconcellos 16:38, 28 November 2006 (UTC)

ANOTHER PERSONAL EXPERIENCE
Whilst using isotretinoin i did have the usual side effects, blood nose, flaking skin, peeling lips. The drug first made my acne worse for the first few weeks then cleared up amazingly. After using isotretinoin, about 3 months later, my acne started to come back gradually. I was under the impression that this drug was only used for a course or two, then not needed again. If so, does anyone know of a reason that the acne came back.

Reply: Your dermatologist may have you on a second course of the treatment. You should make an appointment with your derma soon.. She/He can answer all your questions


 * I have been given a prescription to accutane, and my doctor says that over the first few weeks, it will get worse, and then will clear up. He said it takes an average of six months for the drug to work, and after this the acne should not return. Thomasiscool 14:26, 25 April 2007 (UTC)

Sorry, that's not quite right; There is a period of 10-12 days during which the acne gets somewhat worse. After that period, it begins to clear up and you can start to see improvement. It apparently takes up to 2 months for a major improvement to occur, and it is only after an average time of 6 months that you can stop using isotrentinoin and be reasonably certain that the acne will not return (it is successful in 90% of patients). Fuck, I should have been on this stuff years ago. Thomasiscool 00:10, 22 May 2007 (UTC)

Yet another personal experience
I was prescribed Accutane, 20 mg per day, back in August 1996 for acne. After four months, I noticed improvements (having some of the common side effects like nosebleeds and cracked lips), but for no discernable reason, I became increasingly depressed and ultimately attempted suicide (alcohol and large quantity of assorted pills) in January 1997. At the time, depression and possible suicidal tendencies, I believe, were poorly or not at all known side effects of Accutane use, so my inexplicable depression was not linked to that. I was prescribed Paxil and took the two concurrently for four weeks, at which point, I attempted suicide again (codeine overdose and alcohol) and probably would have succeeded if not for some friends catching me and forcing me to vomit shortly after my consumption of the medication. I immediately discontinued both medications the next day, and within two weeks, my depression was entirely gone like it had never existed.

I was also diagnosed with Crohn's Disease about three years after stopping Accutane, but I believe that this is simply coincidental. I am utterly convinced that my depression and suicidal tendencies are entirely attributable to this medication, however. Draw your own conclusions.

This medication may be a godsend for many, but for others, it is a horror story; to neglect this possibility is simply irresponsible. I don't think that the medication should be banned by any means, but patients prescribed Accutane should be closely monitored. Vorpal22 19:38, 14 July 2007 (UTC)

AVAILABILITY
Thomas, why do you keep taking out the Availability section? This is not useful information?


 * The reason I keep removing it is because the information that was there is not true. "Accutane is available in the following countries without a prescription: Canada (Except for Canadians)." What's that even supposed to mean? For one thing, you can't legally get it here without a prescription. Does this statement refer to Americans who can't get it easily in the States buying it illegally in Canada? Please explain. Thomasiscool 15:35, 18 June 2007 (UTC)

Yes, I have purchased Isotretinoin from Canada, without a prescription, via the internet from inhousepharmacy.com. Could you put back this section, and perhaps improve upon it? This would help others in obtaining the drug, for use at low dosages. In Mexico you can get it without a prescription, but you would have to go there since they observe the US laws on imports. Some independent person put Romania, but I don't know about that.


 * Yeah, I don't see why we can't put it back in if its improved. We may need a source for some of the information though. Thomasiscool 16:10, 24 June 2007 (UTC)

Unsourced edits
An anonymous user is attempting to modify this article to spread the opinion that low dose treatment is as effective as treatment at clinically-tested levels. This belief doesn't seem to be supported by research, and the anonymous user is not citing any sources for these claims. Please discuss your rationale for making these unsourced edits. Rhobite 06:14, 9 August 2007 (UTC)

2 sources are currently included which deal with low-dose treatment. Amichai B, Shemer A, Grunwald M (2006) does conclude that treatment was effective but as explained in the limitations text, it was noncomparative and open-label. It was also performed on patients with moderate, not severe, acne. The 2nd reference, Seukeran DC, Cunliffe WJ is a case report, not a study, and it is not useful for drawing conclusions. Neither reference is sufficient to support the anonymous user's claims such as "For reasons unknown, high dosages of the drug became mainstream in treatment". Obviously high doses are the standard because they were proven to work through many clinical studies. There is no reference for statements such as "Isotretinoin used to be prescribed after other acne treatments failed to produce results", or the claim that high dose treatment "multiplies the cost of the medicine by 4 to 8 times", or the claim that "pharmacists recommend 5mg to 10mg per day". Rhobite 13:13, 9 August 2007 (UTC)

Some person named Rhobite is making statements without producing any references supporting her statements. Anonymous User 13:58, 13 September 2007 (UTC) Let's look deeper into one of the experiments that she says is not valid:

--- START ABSTRACT ---

Background

The efficacy of isotretinoin at 0.5 to 1.0 mg/kg per day in the treatment of acne is well established and considered safe, although it is sometimes not easily tolerated because of its cutaneous side effects.

Objective

The purpose of this study was to determine the efficacy of low-dose isotretinoin in the treatment of acne.

Methods

In this prospective, noncomparative, open-label study, 638 patients, both male and female, with moderate acne were enrolled and treated with isotretinoin at 20 mg/d (approximately 0.3-0.4 mg/kg per day) for 6 months. The patients were divided into two age groups: 12 to 20 and 21 to 35 years old. Patients were evaluated at 2-month intervals by means of clinical and laboratory examinations. A 4-year follow-up was also carried out.

Results

At the end of the treatment phase, good results were observed in 94.8% of the patients aged 12 to 20 years, and in 92.6% of the patients aged 21 to 35 years. Failure of the treatment occurred in 5.2% and 7.4% of the two groups, respectively. Twenty-one patients dropped out of the study because of lack of compliance, and another patient discontinued participation because of a laboratory side effect. During the 4-year follow-up period, relapses of the acne occurred in 3.9% of the patients aged 12 to 20 years and in 5.9% of the patients aged 21 to 35 years. Elevated serum lipid levels (up to 20% higher than the upper limit of normal value) were found in 4.2% of the patients and abnormal (<twice the upper limit of normal values) liver tests were observed in 4.8%.

Limitations

This was a noncomparative, open-label study.

Conclusion

Six months of treatment with low-dose isotretinoin (20 mg/d) was found to be effective in the treatment of moderate acne, with a low incidence of severe side effects and at a lower cost than higher doses.

--- END ABSTRACT ---

The experiment was for 638 patients, and included a 4 year follow up. I'd say that's pretty thorough Anonymous User 13:58, 13 September 2007 (UTC). Perhaps she needs more proof:

http://www.uspharmacist.com/oldformat.asp?url=newlook/files/Feat/apr00iso.cfm&pub_id=8&article_id=508

http://archderm.ama-assn.org/cgi/content/abstract/130/3/319

http://www.blackwell-synergy.com/doi/abs/10.1111/j.1365-4362.1994.tb01500.x

http://www.blackwell-synergy.com/doi/abs/10.1111/j.1365-4362.1994.tb01500.x

http://www.blackwell-synergy.com/doi/abs/10.1111/j.1468-3083.1998.tb00763.x

http://content.karger.com/ProdukteDB/produkte.asp?Aktion=ShowFulltext&ProduktNr=223854&Ausgabe=227284&ArtikelNr=45270

To have any credibility whatsoever, this Rhobite person needs to produce experiments showing that low dosage isotretinoin treatments are NOT effective. Anonymous User 13:58, 13 September 2007 (UTC)


 * Please stop removing citation needed tags from the article without adding sources. You have never added a citation saying that "Isotretinoin used to be prescribed after other acne treatments failed to produce results", for instance. All you've done is linked to a handful of articles, some of them simple clinical reports (not double blind studies) suggesting that low dose treatment is also effective. You have never linked to anything saying that doctors no longer prescribe high dose treatments. You have never cited your statement that high dose treatment is the standard "for reasons unknown". You never cited your claim that high dose treatment is 4 to 8 times as expensive. Rhobite 14:28, 22 September 2007 (UTC)

Make a change that is a compromise, and I'll consider it. Find out how much more it costs to be on a higher dosage, and post a link. If you know the reason they used higher dosages, when lower dosages are effective, then provide the reason. If you find any study or experiment or report showing that low dosage treatments shouldn't be used before a high dosage, provide it. But please, not anything from Roche. From any party that does not have a financial interest. Like I've said before: try contributing. Facts are useful. 208.54.94.80 06:27, 23 September 2007 (UTC)Anonymous User


 * It isn't up to me to dig up sources to refute your statements. It's your duty to provide reliable sources, something you have not done for almost everything you wrote. See WP:CITE. "Any material that is challenged and for which no source is provided may be removed by any editor." I don't have enough time to fight with you over this. Congrats, your participation has resulted in a Wikipedia article with false medical information which could dissuade people from getting beneficial medication. Rhobite 12:15, 30 September 2007 (UTC)


 * Rhobite, I would feel more comfortable with your statements if you would provide some study that showed the use of isotretinoin at lower dosages was ineffective. I have not been able to find any.  Surely at some point in history they tried different dosages to determine best efficacy. Campoftheamericas  —Preceding signed but undated comment was added at 03:30, 2 October 2007 (UTC)


 * I'm not saying it's ineffective. The articles (some of them are not studies) you posted suggest that low-dose treatment is effective, but requires retreatment much more than if the patient received the recommended dose treatment. This is confirmed by actual studies such as . "Three different dosing levels (0.1, 0.5, 1.0 mg/kg/day) were used in equal-sized groups. ... There was no significant difference in the clinical response between dosages. However, 42% of the patients who received 0.1 mg/kg/day of isotretinoin required retreatment with the drug." In any case, you are mischaracterizing the consensus of research. And you have never provided any reference to back up your claim that high-dose treatment is no longer recommended by the FDA, or your claim that it costs 4-8 times as much as low-dose treatment. Rhobite 14:38, 6 October 2007 (UTC)


 * The study you cite had funding from Roche.
 * Here is an example showing the relationship between funding and results: "Industry funding of nutrition-related scientific articles may bias conclusions in favor of sponsors' products, with potentially significant implications for public health." Quote from: http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371%2Fjournal.pmed.0040005
 * "Dr. Strauss was a consultant and investigator for Roche Laboratories receiving honoraria and grants" Quote from: "http://www.guideline.gov/Compare/comparison.aspx?file=ACNE2.inc"
 * "On Nov. 18, David J. Graham, MD, MPH, from the FDA Office of Drug Safety, Center for Drug Evaluation and Research, testified at a Senate hearing and criticized the agency's performance in monitoring drug safety. His testimony highlighted five drugs: ...acne drug isotretinoin (Accutane; Roche)..." Quote from: "http://www.lomasin.com/19691231/Reform-of-Postmarketing-Drug-Surveillance-System-Needed-Experts-Say,696/"

The stance, adopted by "Rhobite" does not seem to be supported by the Paediatric Working Group of the Committee on the Safety of Medicines [a UK non-departmental committee of doctors, which advises the Medicines and Healthcare Regulatory Authority and the British Goverment]. Their report "Review of Paediatric Data- Isotretinoin", which is available on the MHRA web site, contains data, which are more in line with the views of Rhobite's opponents. As, acording to many articles in "Private Eye", a majority of the CSM's members, in recent years, have been in the pay of drug companies, one would naturally expect these grandees to put financial interests (principally their own) before those of the patient (and the same is true of many, if not most, British doctors). However, there comes a time when even the advisers of King Canute cannot ignore the rising tide.

EVC —Preceding unsigned comment added by Evieconrad (talk • contribs) 14:01, 17 October 2007 (UTC)

another personal experience.
Well I'm currently on a course of Isotretinoin. I've been on my course for just over the 2 out of 3 months i've been prescribed. Up until about a week ago, it's been really great, apart from the temporary side-effects, which I can live with for the time being. However, whilst still on the drug my acne has aggressively flared up in the past week, which is not good news. It should also be noted on the page that alcohol is generally not permitted whilst on a course of Isotretinoin. —Preceding unsigned comment added by Firmager (talk • contribs) 22:42, 5 October 2007 (UTC)

is safe.!!
Bold text —Preceding unsigned comment added by 196.205.233.238 (talk) 01:25, 16 May 2008 (UTC)

Sever Acne with liver disease
He's the history .. Male patient of 18 Years old and suffers from sever acne,, this patient had Drugs induced Jaundice.. thu Isotretinoin wansnt part of these drugs,, but is it safe to use Isotretinoin with a patient having liver disease.. or HAD liver disease?.. if it's ok to use it .. then how to apply !! thnx Dr.sherif

Conflicting Dates
At one point, it says treatment is typically 8-10 months. Later, it says a typical treatment takes 12-16 weeks (this is definitely inaccurate, though I have no sources). In general, from what I understand, a typical course would be more like 5-10 months depending on dose, etc. 69.11.87.71 (talk) 18:43, 2 December 2015 (UTC)

Telomere Activity
Just deleted a section from the pharmacodynamics section of the page talking about retinoid activity related to telomerase down-regulation. The article used as a source for claims that telomerase activity is isotretinoin's method of action came from an article found here: . Telomerase down-regulation must be one of tretinoin's effects (tretinoin being a metabolite of isotretinoin). However, I can't find a single publication suggesting that this is isotretinoin's method of action on sebaceous glands, making me think that the author of the section must have posted it as a personal theory. More commonly-accepted hypotheses about isotretinoin's method of action can be found here:  —Preceding unsigned comment added by 98.216.97.88 (talk) 03:39, 27 March 2010 (UTC)

Brand names
Duplicate in the head of the article and in the text, and the information does not match! —Preceding unsigned comment added by 83.76.57.251 (talk) 15:10, 7 September 2008 (UTC)

Unsourced edits
An anonymous user is attempting to modify this article to spread the opinion that low dose treatment is as effective as treatment at clinically-tested levels. This belief doesn't seem to be supported by research, and the anonymous user is not citing any sources for these claims. Please discuss your rationale for making these unsourced edits. Rhobite 06:14, 9 August 2007 (UTC)

2 sources are currently included which deal with low-dose treatment. Amichai B, Shemer A, Grunwald M (2006) does conclude that treatment was effective but as explained in the limitations text, it was noncomparative and open-label. It was also performed on patients with moderate, not severe, acne. The 2nd reference, Seukeran DC, Cunliffe WJ is a case report, not a study, and it is not useful for drawing conclusions. Neither reference is sufficient to support the anonymous user's claims such as "For reasons unknown, high dosages of the drug became mainstream in treatment". Obviously high doses are the standard because they were proven to work through many clinical studies. There is no reference for statements such as "Isotretinoin used to be prescribed after other acne treatments failed to produce results", or the claim that high dose treatment "multiplies the cost of the medicine by 4 to 8 times", or the claim that "pharmacists recommend 5mg to 10mg per day". Rhobite 13:13, 9 August 2007 (UTC)

Some person named Rhobite is making statements without producing any references supporting her statements. Anonymous User 13:58, 13 September 2007 (UTC) Let's look deeper into one of the experiments that she says is not valid:

--- START ABSTRACT ---

Background

The efficacy of isotretinoin at 0.5 to 1.0 mg/kg per day in the treatment of acne is well established and considered safe, although it is sometimes not easily tolerated because of its cutaneous side effects.

Objective

The purpose of this study was to determine the efficacy of low-dose isotretinoin in the treatment of acne.

Methods

In this prospective, noncomparative, open-label study, 638 patients, both male and female, with moderate acne were enrolled and treated with isotretinoin at 20 mg/d (approximately 0.3-0.4 mg/kg per day) for 6 months. The patients were divided into two age groups: 12 to 20 and 21 to 35 years old. Patients were evaluated at 2-month intervals by means of clinical and laboratory examinations. A 4-year follow-up was also carried out.

Results

At the end of the treatment phase, good results were observed in 94.8% of the patients aged 12 to 20 years, and in 92.6% of the patients aged 21 to 35 years. Failure of the treatment occurred in 5.2% and 7.4% of the two groups, respectively. Twenty-one patients dropped out of the study because of lack of compliance, and another patient discontinued participation because of a laboratory side effect. During the 4-year follow-up period, relapses of the acne occurred in 3.9% of the patients aged 12 to 20 years and in 5.9% of the patients aged 21 to 35 years. Elevated serum lipid levels (up to 20% higher than the upper limit of normal value) were found in 4.2% of the patients and abnormal (<twice the upper limit of normal values) liver tests were observed in 4.8%.

Limitations

This was a noncomparative, open-label study.

Conclusion

Six months of treatment with low-dose isotretinoin (20 mg/d) was found to be effective in the treatment of moderate acne, with a low incidence of severe side effects and at a lower cost than higher doses.

--- END ABSTRACT ---

The experiment was for 638 patients, and included a 4 year follow up. I'd say that's pretty thorough Anonymous User 13:58, 13 September 2007 (UTC). Perhaps she needs more proof:


 * http://www.uspharmacist.com/oldformat.asp?url=newlook/files/Feat/apr00iso.cfm&pub_id=8&article_id=508


 * http://archderm.ama-assn.org/cgi/content/abstract/130/3/319


 * http://www.blackwell-synergy.com/doi/abs/10.1111/j.1365-4362.1994.tb01500.x


 * http://www.blackwell-synergy.com/doi/abs/10.1111/j.1365-4362.1994.tb01500.x


 * http://www.blackwell-synergy.com/doi/abs/10.1111/j.1468-3083.1998.tb00763.x


 * http://content.karger.com/ProdukteDB/produkte.asp?Aktion=ShowFulltext&ProduktNr=223854&Ausgabe=227284&ArtikelNr=45270

To have any credibility whatsoever, this Rhobite person needs to produce experiments showing that low dosage isotretinoin treatments are NOT effective. Anonymous User 13:58, 13 September 2007 (UTC)


 * Please stop removing citation needed tags from the article without adding sources. You have never added a citation saying that "Isotretinoin used to be prescribed after other acne treatments failed to produce results", for instance. All you've done is linked to a handful of articles, some of them simple clinical reports (not double blind studies) suggesting that low dose treatment is also effective. You have never linked to anything saying that doctors no longer prescribe high dose treatments. You have never cited your statement that high dose treatment is the standard "for reasons unknown". You never cited your claim that high dose treatment is 4 to 8 times as expensive. Rhobite 14:28, 22 September 2007 (UTC)

Make a change that is a compromise, and I'll consider it. Find out how much more it costs to be on a higher dosage, and post a link. If you know the reason they used higher dosages, when lower dosages are effective, then provide the reason. If you find any study or experiment or report showing that low dosage treatments shouldn't be used before a high dosage, provide it. But please, not anything from Roche. From any party that does not have a financial interest. Like I've said before: try contributing. Facts are useful. 208.54.94.80 06:27, 23 September 2007 (UTC)Anonymous User


 * It isn't up to me to dig up sources to refute your statements. It's your duty to provide reliable sources, something you have not done for almost everything you wrote. See WP:CITE. "Any material that is challenged and for which no source is provided may be removed by any editor." I don't have enough time to fight with you over this. Congrats, your participation has resulted in a Wikipedia article with false medical information which could dissuade people from getting beneficial medication. Rhobite 12:15, 30 September 2007 (UTC)


 * Rhobite, I would feel more comfortable with your statements if you would provide some study that showed the use of isotretinoin at lower dosages was ineffective. I have not been able to find any.  Surely at some point in history they tried different dosages to determine best efficacy. Campoftheamericas  —Preceding signed but undated comment was added at 03:30, 2 October 2007 (UTC)


 * I'm not saying it's ineffective. The articles (some of them are not studies) you posted suggest that low-dose treatment is effective, but requires retreatment much more than if the patient received the recommended dose treatment. This is confirmed by actual studies such as . "Three different dosing levels (0.1, 0.5, 1.0 mg/kg/day) were used in equal-sized groups. ... There was no significant difference in the clinical response between dosages. However, 42% of the patients who received 0.1 mg/kg/day of isotretinoin required retreatment with the drug." In any case, you are mischaracterizing the consensus of research. And you have never provided any reference to back up your claim that high-dose treatment is no longer recommended by the FDA, or your claim that it costs 4-8 times as much as low-dose treatment. Rhobite 14:38, 6 October 2007 (UTC)


 * Rhobite, just admit you work for Roche or other pharm company marketing high dose isotretinoin treatments. haha ;) 74.92.162.238 (talk) 21:53, 29 December 2011 (UTC)


 * The study you cite had funding from Roche.
 * Here is an example showing the relationship between funding and results: "Industry funding of nutrition-related scientific articles may bias conclusions in favor of sponsors' products, with potentially significant implications for public health." Quote from: http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371%2Fjournal.pmed.0040005
 * "Dr. Strauss was a consultant and investigator for Roche Laboratories receiving honoraria and grants" Quote from: "http://www.guideline.gov/Compare/comparison.aspx?file=ACNE2.inc"
 * "On Nov. 18, David J. Graham, MD, MPH, from the FDA Office of Drug Safety, Center for Drug Evaluation and Research, testified at a Senate hearing and criticized the agency's performance in monitoring drug safety. His testimony highlighted five drugs: ...acne drug isotretinoin (Accutane; Roche)..." Quote from: "http://www.lomasin.com/19691231/Reform-of-Postmarketing-Drug-Surveillance-System-Needed-Experts-Say,696/"

The stance, adopted by "Rhobite" does not seem to be supported by the Paediatric Working Group of the Committee on the Safety of Medicines [a UK non-departmental committee of doctors, which advises the Medicines and Healthcare Regulatory Authority and the British Goverment]. Their report "Review of Paediatric Data- Isotretinoin", which is available on the MHRA web site, contains data, which are more in line with the views of Rhobite's opponents. As, acording to many articles in "Private Eye", a majority of the CSM's members, in recent years, have been in the pay of drug companies, one would naturally expect these grandees to put financial interests (principally their own) before those of the patient (and the same is true of many, if not most, British doctors). However, there comes a time when even the advisers of King Canute cannot ignore the rising tide.

EVC —Preceding unsigned comment added by Evieconrad (talk • contribs) 14:01, 17 October 2007 (UTC)

Side effects or Accutane
I was redirected here from Accutane, which I took some years ago for acne, and my doctor said that one of the side effects were defomrmations in babies conceived while under Accutane. In short, I couldn't get anyone pregnant, nor could any woman on Accutane get pregnant without risking their child being deformed. He said it fell under a category of medications whose name I can't remember, but it was Latin for "maker of monsters". Since I don't have any verifiable source for this, I won't add it, but I'd like for someone to find the appropriate sources and add it to the article.--190.18.47.103 (talk) 03:03, 6 February 2009 (UTC)
 * There's plenty of information on the teratogenicity (greek for maker of monsters, not latin) of isotretinoin in the article allready under the subheading: Teratogenicity (birth defects) Dakoman (talk) 23:47, 6 February 2009 (UTC)

Drug Recall
Something in this article needs to mention the fact that this drug has been recently recalled. Ink Falls   03:01, 18 May 2010 (UTC)
 * It hasn't. This article is about isotretinoin, which a multitude of companies continue to produce and sell.  Accutane was withdrawn from the (American) market, but that's just one brand. 93.97.131.76 (talk) 08:01, 3 November 2010 (UTC)

Irritable Bowel Disorder?
In the "Removal" section, it says "they were having to spend to defend themselves from claims that Accutane caused patients to develop Irritable Bowel Disorder." There is no such thing as Irritable Bowel Disorder. There is Inflammatory Bowel Diseases (which is what Crohn's and UC falls under) and Irritable Bowel Disease, which is something else. 98.220.211.83 (talk) 01:54, 24 January 2011 (UTC)

Outdated links
For medication guide i suggest 
 * First two external links
 * reference 9

Jeez- there was a lot of rubbish on this page. — Preceding unsigned comment added by Dermatoman (talk • contribs) 13:07, 20 August 2013 (UTC)

Recent additions come across as advertising/damage control
Some additions in the last month come across almost as Astoturfing, such as these edit ranges:
 * by an IP
 * by Dermatoman

I've reverted to a previous version for the time being. Can I recommend anyone wanting to alter the article to take a more "pro" stance discuss the changes here first. SynergyBlades (talk) 00:42, 26 August 2013 (UTC)

Edits
Hi all,

this was a pretty terribly written article... originally.

i don't know what 'astroturfing' means- maybe you could enlighten me?

very little scientific evidence was presented orinally.

most 'facts' were about the outcomes of legal trials, not the outcomes of scientific studies... and even those implied incorrectly that some actor won his case. Lets make it clear- anybody can sue anybody over anything- what matters is SCIENCE!

please do not remove any points that have scientifically published references.

i have put a heading "Studies showing association with depression".. please add any published studies with references.

if you have 'disagree' with my edit, please provide REFERENCED arguments from medical journals not newspaper articles!

i was astounded that all those changes were deleted- completely inappropriate... Vandalism i would say.

i agree that this article should NOT have a 'pro' or 'anti' bias but should reflect scientific studies!

obviously ALL MEDICATION has side effects... and the concern for physicians and patients prescribing this one are primarily: depression - although the vast majority of clinical studies in humans show either no link or improvement- this is not an opinion but a fact. night vision changes- more info on restrctions re people wishing to become pilots etc needs to be added to this article.. inflammatory bowel disease- ulcerative colitis (not crohns).. this is a concern teratogenicity- this is the most significant issue... although not for men. heart: the recent study concerning LVH is concerning... followup studies will be very interesting.

By the way - i am in NO WAY trying to promote this medication. I am not affiliated with any drug company- nor do i accept any drug company sponsorship/funding. I am only interested in the facts. I do, however, have personal knowledge of this medication, having prescribed it about 20 times per week for the last 12 years. More than anyone i am concerned that atients and the general public have a non-biased reference such as wikipedia to access.... there are plenty of 'i hate accutane' websites out there.

Dermatoman — Preceding unsigned comment added by Dermatoman (talk • contribs) 02:19, 26 August 2013 (UTC)

Legal issues
would anyone have an objection if we moved the legal issues into a separate paragraph? legal issues and scientific / medical issues are separate... — Preceding unsigned comment added by Dermatoman (talk • contribs) 02:10, 27 August 2013 (UTC)


 * I think separating the legal from medical issues makes sense. There is a style guide for drug article (see WP:PHARMMOS and in particular the section section). The style guide recommends an optional "Society and culture" section with "Legal status" and "Controversies" subsections. Boghog (talk) 06:21, 27 August 2013 (UTC)


 * I'm alarmed by removal of any mention of the SMART program (2000), which should be covered in much more detail here. To my recollection, the most notable thing about this drug is the way that regulatory policy was used to extend a company's patent monopoly, then to force the use of alternatives when that unravelled.  MEDRS should not apply at all to political, legal, and ethical issues. Wnt (talk) 17:55, 21 May 2014 (UTC)


 * I've no objection to you re-adding content about the SMART program, if in your judgement is needs to be in the article. AGK  [•] 18:11, 21 May 2014 (UTC)


 * I am alarmed at the description of SMART as a program "used to extend a drug's patent monopoly". That kind of conspiratorial thinking has no place in WP.  Our article used to say: "On the grounds that pregnancies by women taking the drug had been underreported by the manufacturer between 1982 and 2000, and that, once generic manufacturers entered the market risk management was no longer centralized, the FDA instituted restrictions on prescribing and dispensing the drug, first with the "System to Manage Accutane Related Teratogenicity" (SMART) in 2000, and subsequently the iPLEDGE program in 2006. A retrospective cohort study recently found that pregnancy rates were quite high during the period (one per 30 women per year), and 84% of pregnancies were ended by induced abortion.[102]"  Ref 102 was a primary study, not a review. (PMID 17214828).  I think that old text was fine - it showed the FDA working collaboratively with industry to keep a get or keep a useful drug on the market with appropriate controls, like it did for thalidomide when it was brought back as a cancer drug.  It needs a better source...Jytdog (talk) 18:22, 21 May 2014 (UTC)


 * The article does currently discuss iPLEDGE - in the prescribing restrictions section.  We do need better refs for that. this might be good: https://www.ncbi.nlm.nih.gov/pubmed/24688620  this also looks good. It discusses the failure of SMART too.Jytdog (talk) 18:54, 21 May 2014 (UTC)


 * I have no objections to re-adding SMART, which I deleted for the same reason I deleted the statement that "No evidence ties isotrention to psychiatric disorders" - because it was improperly sourced. However, I think the following would be important considerations:


 * iPLEDGE is discussed very extensively, and both iPLEDGE and SMART are U.S. only programs. To avoid excess U.S.-centricism, the iPLEDGE disucussion shold be reduced if SMART is included.
 * Anything added should be sourced with reliable, secondary sources.
 * It needs to be NPOV. This means than any theories that SMART was a vast conspiracy to increase Roche profits need to be supported by reliable secondary references demonstrating this intent, such as quotes to this effect from the FDA officials who set it up, court rulings, or a mainstream news article that credibly makes the case that this was a mainstream viewpoint, and not the editorial opinion of a few extreme critics. Any such claims should also address the fact that Accutane sales plunged in the aftermath of the initiation of SMART, falling 16% in 2002, an additional 37% in 2003, and yet another 37% in 2004.  By 2005, Accutane, which was Roche's 3rd biggest-selling product in 2001, was no longer in the top 20.  If the goal of making doctors and patients jump through all kinds of hoops to get an Accutane Rx filled was to fill Roche's coffers, it was one of the most ill-considered plans in corporate history.
 * Formerly 98 (talk) 21:37, 21 May 2014 (UTC)


 * Postscript: this was written in too harsh of a tone. I apologize for that, but stand by the general concepts expressed. Just do me a favor and try to ignore the emotional tone, which I regret.Formerly 98 (talk) 21:56, 21 May 2014 (UTC)

Edits of May 10-17 2014
WP:OR does not allow original research, including original syntheses arrived at by combining ideas not combined in source documents (WP:OR. My edits performed on the basis of this include removing material as follows:


 * May 10 at 20:56:
 * Adverse events discussed in the History section that were already covered in great detail under Adverse Effects
 * Statements about the percent of users receiving pregnancy tests, supported only by a primary reference
 * Discussion of iPLEDGE, already covered under Adverse Events in great detail
 * A statement about pregnancy rates and abortion rates supported only by primary research.


 * May 10 at 20:53
 * "Dosage requirements of isotretinoin have been disputed. After a 1984 study funded by Roche, relatively high dosages of isotretinoin became mainstream in treatment in the United States. Lower dosages were found to be effective in treatment by independent research (see dosage section)." Redundant

* May 10 at 20:09
 * 4 case reports used as sources. Accordig to WP:MEDRS "Case reports and other anecdotes fall below the standard of reliable sources"
 * Several sentences consisting entirely of WP:OR regarding growth stunting.

If you consider adding original research and MEDRS non-compliant sources as helpful, and removing them "vandalism", we are not likely to agree. On the other hand, if you can support that material by identifying secondary sources, I have no object to you re-adding it. Formerly 98 (talk) 23:43, 17 May 2014 (UTC)

There is no original research after I rephrased the text. Please explain your motives of removing referenced text relevant to the topic without any discussion whatsoever. Until you do, the text sits there. User:User931 11:36, 21 May 2014 (UTC)


 * User:User931, Motivations of editors are not relevant, and the discussion above has existed since last week.   About "motivations", we discuss content, not contributors here; instead discussion of content is based on policies and guidelines.   Please see Talk page guidelines (all of it) but especially the section on what is good to do and what not to do.  It is great that you are joining the discussion.  Would you please engage with the justifications provided?  Thanks. Jytdog (talk) 11:04, 21 May 2014 (UTC)

As I've said several times, you are removing referenced text from scientific journals relevant to the topic without raising a discussion here and wait until others have expressed their opinions. Therefore the text sits until you do so. User:User931 12:37, 21 May 2014 (UTC)


 * OK, we're discussing it now that you've finally decided to join us. Please address the points I've made above explaining these edits and why you don't think they are valid.


 * Please be aware that MEDRS does not permit using any "medical text" as a source for statements in articles. They have to be 1) secondary, and 2) narrow restrictions are placed on making statements that are based on results in cell culture or in animals. So your repeated argument that this material is "referenced from medical texts" is not meaningful unless you show that the sources are also MEDRS compliant.


 * Threatening to edit war is not going to be helpful to your cause. Please address the points made above.Formerly 98 (talk) 13:36, 21 May 2014 (UTC)

I've contributed to this article in the past, but only as a copyeditor; I am not a medical expert in any way. Nevertheless, I can perhaps offer some assistance with this disagreement. On balance, I am inclined to agree with Formerly 98's evaluation. Isotretinoin appears to be a complex substance, and its long-term effects are still unclear. Giving significant weight to ostensible permanent side effects when these effects are not widely accepted among dermatologists is therefore problematic and should be avoided. Wikipedia guidelines on sourcing appear to require that we not present the result of in vacuo studies as accepted fact unless the medical science community consider those results generalisable. Thus: Further comments welcome. (I would also remind you that edit warring over content is prohibited. Site policy requires that you talk it out!) AGK  [•] 15:35, 21 May 2014 (UTC)
 * The new "adverse effects" should be removed or given the weight of a single sentence. At the moment, we are basically giving the impression to readers that this substance can cause hundreds of different effects, depending on which study you believe, but these effects are not recognised in the medical literature (to the best of my knowledge, which is primarily gleamed from the rest of the article and related reading).
 * iPLEDGE is already documented in tedious detail and I agree extending our coverage of it is suboptimal. This is doubly so, given that it is of interest only to American readers.
 * The percentage of users made to take a pregnancy test is not satisfactorily sourced and must be removed. More to the point, are reliable statistics on the proportion of tested patients even maintained? I was given to understand this is down to the discretion of the prescribing physician.
 * Ditto the preceding point for abortions. No sourcing, therefore no inclusion.
 * Easiest would be to say, "Dosage is down to individual physician discretion. The manufacturer recommends a dose in the range of A–B units per Y other-units of body weight." We shouldn't cause significant confusion in our coverage of how the substance is dosed with countless studies debating the merits of various levels of dosage.
 * Growth stunting seems to be covered under my first submitted point in this list.


 * Separately from the above, I have just copyedited the Possible permanent effects section to remove significant duplication, reduce it to a single block of prose (excess use of sub-headings is confusing to the reader), and – hopefully – make the section easier for us to work on. AGK  [•] 15:40, 21 May 2014 (UTC)


 * Isotretinoin actually seems to be a somewhat ugly drug. The package insert contains strong warnings about psychological effects including hostility, aggressiveness, psychotic episodes and depression. I'd like to see this added.  There is also a pretty good discussion there about the risk of lipid abnormalities, and Hyperostosis (which can happen with either high doses or extended use). My goal here is not to soft pedal the side effects of this drug, but to get them accounted for accurately and in a properly referenced manner. There appears to be a general consensus on the MEDRS board that package inserts serve as secondary references, so that would be an easy way to add these.Formerly 98 (talk) 16:13, 21 May 2014 (UTC)
 * The drug plainly is pretty strong and nasty stuff, yes. The article should indeed reflect that. The problem is that, for years, it's been plagued by drive-by editors who insist on adding all sort of side-effects, with a link to some tiny trial or a speculative article in a backwater journal. I suspect this has distracted and hampered article development. In fact, the article really should just document the side-effects the drug is generally accepted to cause; going by what the drug leaflet and medical textbooks say may be a good rule of thumb to adopt. Anything else could probably be culled. What do you think? AGK  [•] 16:44, 21 May 2014 (UTC)
 * I agree, and that is very much what my perspective is on this. But wonder if should hold off given 1) I have posted to admin noticeboard (before the article was protected), and may be some discussion there, and 2) unlikely to gain consensus by editing while protected from non-admins.  I suspect User931 will be pretty unhappy with that situation. Formerly 98 (talk) 16:55, 21 May 2014 (UTC)
 * Not intending to sound like a douchebag but reading your conversation makes it somewhat clear you have limited understanding of medicine, toxicity, side-effects reporting, pharmaceutical industry and research funding/grants. "the article really should just document the side-effects the drug is generally accepted to cause." and "I agree". ... User:User931 22:13, 23 May 2014 (UTC)

all i can say is... ouch. very unhelpful remark. and not relevant. you are continuing to make personal attacks instead of dealing with the issues. please, please discuss content, not contributors. Please speak to the guideline-and-policy based objections that have been raised. Please. Thanks. Jytdog (talk) 21:23, 23 May 2014 (UTC)


 * Well, I'm happy to stipulate that you know much more about all these things that I do, but that's not really what we're here to discuss.


 * If I could recap our discussion to date as I have understood it:


 * I deleted a number of statements from the article
 * You reverted these changes, stating that I could not delete the information based on the fact that I had "removed properly referenced medical content without discussion"
 * I provided an explanation of my edits, and explained that most were based on redundancy and MEDRS non-compliant sources. I added that not all "medical references" were reliable sources according to long-standing Wikipedia policy (MEDRS)
 * You repeatedly declined to interact on the Talk page or to address my points. Instead you repeatedly reverted my edits and kept repeating the argument that these were "medically referenced" and that I could not delete them.
 * Coming back to the discussion after an admin got involve and threatened to block you, your new response is that I am ignorant.


 * None of this is helpful. Not yielding 100% to your preferences is not synonymous with "making changes without discussion".  "Medically referenced" is not synonymous with MEDRS compliant. We've been offering to discuss for a week, but you mostly revert without joining the discussion, and when you do you argue off topic and hurl insults.


 * Happy to discuss still if you change your mind. Formerly 98 (talk) 01:48, 24 May 2014 (UTC)



Back to specific content dispute
Looking over the edit history, User:User931 has been restoring the following sources, which Formerly98 said were removed due to WP:OR
 * dif: https://en.wikipedia.org/w/index.php?title=Isotretinoin&diff=609521950&oldid=609520897


 * Pittsley, Richard A.; Yoder, Frank W. (1983). "Retinoid Hyperostosis". 308 (17): 1012–4. doi:10.1056/NEJM198304283081707..


 * Novick, Nelson Lee; Lawson, William; Schwartz, Ira S. (1984). "Bilateral nasal bone osteophytosis associated with short-term oral isotretinoin therapy for cystic acne vulgaris". 77 (4): 736–9. doi:10.1016/0002-9343(84)90376-0..


 * Milstone, LM; McGuire, J; Ablow, RC (1982). "Premature epiphyseal closure in a child receiving oral 13-cis-retinoic acid". 7 (5): 663–6. doi:10.1016/S0190-9622(82)70148-3..


 * Marini, JC; Hill, S; Zasloff, MA (1988). "Dense metaphyseal bands and growth arrest associated with isotretinoin therapy". 142 (3): 316–8.doi:10.1001/archpedi.1988.02150030090029..


 * Montag, M; Reiser, M; Hamm, H; Traupe, H; Vogt, HJ (1988). "Skeletal changes following long-term treatment with retinoids". 28 (7): 320–5..


 * Luthi, François; Eggel, Yan; Theumann, Nicolas (2011). "Premature epiphyseal closure in an adolescent treated by retinoids for acne: An unusual cause of anterior knee pain". . doi:10.1016/j.jbspin.2011.11.001..


 * Student Investigation 6.1. Predicting Height from the Length of Limb Bones


 * De Luca, F.; Uyeda, JA; Mericq, V; Mancilla, EE; Yanovski, JA; Barnes, KM; Zile, MH; Baron, J (2000). "Retinoic Acid is a Potent Regulator of Growth Plate Chondrogenesis". 141 (1): 346–53. doi:10.1210/en.141.1.346..

The “Student Investigation 6.1” qualifies as Original Research, but the medical journal articles deleted don’t. I’m confused by this content dispute.--BoboMeowCat (talk) 22:01, 21 May 2014 (UTC)


 * Nope, only one paragraph was removed due to WP:OR. The rest is due to redundancy or poor sourcing. Please note that nearly all of the references you listed above are primary sources and/or case reports/animal studies/in vitro studies, and therefore inappropriate per WP:MEDRS Formerly 98 (talk) 22:33, 21 May 2014 (UTC)

Protected
Due to recent edit warring, this page has been fully protected for one week, please come to consensus about whatever it is you are arguing about. --kelapstick(bainuu) 14:23, 21 May 2014 (UTC)

So we are supposed to be discussing this while the block is on. Please reply with any new thoughts  and especially   as the rest of us seem to be mostly in agreement.Formerly 98 (talk) 19:01, 23 May 2014 (UTC)
 * I am afraid that User931 has not logged in since the edit war day - no contribs since then. :( Jytdog (talk) 19:21, 23 May 2014 (UTC)

Request for Input at Pharmacology and Medicine Project Pages
I've posted requests to the aforementioned project pages for input on the article and the controversial edits. This might be a good spot for any commentary to be added. Formerly 98 (talk) 12:23, 26 May 2014 (UTC)
 * Thanks for the notice. There was only one objector to the changes you made, and User931 seems to be occupied with RL].  I don't imagine the dispute will come back unless User931 decides to commit more time to this, and at this point consensus is solidly against him/her.Jytdog (talk) 12:30, 26 May 2014 (UTC)


 * The admin who protected the article specifically asked that I seek additional outside input, and this request is in response to that. Formerly 98 (talk) 12:36, 26 May 2014 (UTC)
 * Currently, there is a large table of side-effects included in the article. In my opinion, it's generally not necessary to include rare and very rare side-effects in a general encyclopedia like Wikipedia. This stuff should be in a drugs formulary (the British National Formulary in the UK) and the information leaflet that comes with the medication. Important side-effects (such as teratogenicity with isotretinoin) should be mentioned separately. The qualification of "important" is contingent upon extensive documentation in generic sources about the drug. (Such sources do not include those that specifically describe only the side-effect.) Even when this is met, the description of the side-effect should be kept brief. Axl  ¤  [Talk]  10:14, 27 May 2014 (UTC)

Conflicts of early August 2014


Please note that WP:MEDRS forbids the use of primary research and case reports as sources for medical statements. Specifically,


 * "Primary sources should generally not be used for medical content.", and
 * "Case reports, whether in the popular press or a peer reviewed medical journal, are a form of anecdote and generally fall below the minimum requirements of reliable medical sources."

You have repeatedly re-added the following sources in spite of these prohibitions:, , ,

You have repeatedly moved the text:


 * "Several trials over inflammatory bowel disease claims have been held in the United States thus far, with many of them resulting in multimillion dollar judgments against the makers of isotretinoin.[49] In 2009 Roche decided to pull Accutane off the market, claiming at the time that the move was to stem the tide of Accutane lawsuits.[50] As of January 2012, there were an additional 6,000 cases pending.[51]


 * Among others, actor James Marshall sued Roche over allegedly Accutane-related disease that resulted in removal of his colon.[52] The jury, however, decided that James Marshall had a pre-existing bowel disease.[53]"

out of the History Section and into the Adverse Events section. There is an important difference between these two, as the latter addresses medical facts, and is covered by MEDRS. Including statements about lawsuits regarding IBD in the Adverse Effects section treats them as medical evidence. WP:MEDRS describes the following sources as acceptable for medical content:


 * "It is vital that the biomedical information in all types of articles be based on reliable, third-party, published secondary sources and accurately reflect current medical knowledge.


 * Ideal sources for such content includes literature reviews or systematic reviews published in reputable medical journals, academic and professional books written by experts in the relevant field and from a respected publisher, and medical guidelines or position statements from nationally or internationally recognised expert bodies"

Can you please explain or reverse your actions?

--Formerly 98 (talk) 07:06, 12 August 2014 (UTC)

Roche's suggestion of Pregnancy Category
I am re-adding the the statement this statement to the History section: "Roche asked for a pregnancy category of C on the drug label, but the FDA required a category of X. But there were no explicit controls for pregnancy." User 70.211.65.147 removed this statement on a revision dated 18:00, 14 September 2015 because it was "unsourced, dubious." The statement is in fact sourced in the already cited Julia Green article. The source states: "Roche suggested a pregnancy risk rating of C." — Preceding unsigned comment added by Wikipedialuva (talk • contribs)

The "Greene paper" was written bya student to meet class requirements and has not been reviewed for accuracy by peer reviewers nor editors. The yerms of use for the site where its posted explicitly state that Harvard does not vouch for the accuracy or truthfulness of the papers posted there.

Out it goes.... 70.214.3.18 (talk) 21:47, 2 December 2015 (UTC)

OFC study
Could you explain why you have removed information about the study regarding the effects of the drug on the orbitofrontal cortex? I understand the policy regarding the use of primary sources, but this study is referred to in Bremner et al.'s 2012 meta-analysis which is cited throughout the section on psychiatric effects. This study is particularly significant as it is the only study I am aware of which shows significant differences in neuroimaging in response to isotretinoin therapy. I thought it would be appropriate to include a citation to the original study in addition to the meta-analysis. I would prefer not to be templated for edit warring in line with WP:TEMPLAR. Thanks, LoudLizard (📞 | contribs | ✉) 18:18, 1 June 2017 (UTC)
 * The study is also referred to in this review as well as this article, amongst others. I think there are sufficient secondary sources to warrant inclusion.


 * -- LoudLizard (📞 | contribs | ✉) 18:37, 1 June 2017 (UTC)


 * First, thanks for opening a discussion. Second, would you please please always use the pmid parameter in citations?  It is really useful for checking if refs are primary or secondary and for a bunch of other things - everybody in WP:MED relies on it. Please do use it. Third, discussion about your talk page really belongs there, so please see my response to that there.
 * Getting to the heart of the matter now.  I get it that you want to lay out in detail the underlying reasoning provided in the secondary source for mechanisms through which it is proposed that this drug causes depression in some people.  I get that.  But we don't understand depression that well, and our article on Orbitofrontal cortex doesn't mention depression at all, and even our Biology of depression article which gives the most detail on biological theories of depression, gives abnormalities in this region only a passing mention. So it is enough to simply cite what the secondary source says without drilling way down into the findings of the underlyingprimary sources, and citing them. This has to do with the mission of giving readers "accepted knowledge" (per WP:NOTEVERYTHING)  and this is all just getting more deep in the weeds than an encyclopedia article needs to or should go.  It is a judgement thing and we can honestly disagree.  But that is where i am coming from.  Jytdog (talk) 20:12, 1 June 2017 (UTC)

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Microtia related complication
I am no expert but I heard that Microtia may occur as a complication of taking isotretinoin during pregnancy.  Nik ol ai Ho ☎️ 05:28, 27 September 2017 (UTC)
 * I wouldn't be surprised. Most babies whose mothers are on isotretinoin don't survive until childbirth and if they do they are heavily deformed. Very sad. LoudLizard (📞 | contribs | ✉) 03:06, 21 November 2017 (UTC)

Why are these sources removed?
Why are these sources I added removed? From MHRA at the UK government, and controlled studies. The findings are also consistent with other studies that show the same thing. If I also add the other studies showing the same thing, would you then please not remove them, @Kimen8, but thanks for the edits of grammar.

24.	"Review of isotretinoin and psychiatric adverse reactions" (PDF). Medicines and Healthcare products Regulatory Agency (MHRA). www.gov.uk. November 2014. Retrieved 2 April 2024.

26.	Alamri A, Khafaji R, Balkhy A, Samarkandy S, Alraddadi A (December 2023). "The Psychological Impact of Isotretinoin Therapy on Acne Vulgaris Patients". Cureus. 15 (12): e50612. doi:10.7759/cureus.50612. PMC 10724700. PMID 38107219.

30.	Saraç G, Koca TT, Şener S, Hakverdi G (15 March 2018). "Effect of 6-Month Isotretinoin Treatment on 25-Hydroxyvitamin D Levels in Patients With Acne Vulgaris". Journal of Clinical Medicine of Kazakhstan. 1 (47): 25–28. doi:10.23950/1812-2892-JCMK-00537. ISSN 1812-2892.

31.	Gökalp H, Bulur I, Gürer M (2014). "Decreased vitamin B 12 and folic acid concentrations in acne patients after isotretinoin therapy: A controlled study". Indian Journal of Dermatology. 59 (6): 630. doi:10.4103/0019-5154.143533. ISSN 0019-5154. PMC 4248518. PMID 25484410. Tomsiti (talk) 13:02, 3 April 2024 (UTC)


 * Based on WP:MEDRS, I removed what I thought were WP:PRIMARY sources, including trials/intervention studies. Controlled studies are not to be used as a reference for your insertion, unless you happen to be saying that there exists such a study, perhaps to say that research on some topic is ongoing (i.e., do not use its results conclusively). Favor WP:SECONDARY sources, such literature reviews, meta-analyses, and the like. If you believe any of those do fit WP:MEDRS you are free to put them back. If you add good sources, of course I will not remove them (unless I do so by accident, in which case just WP:AGF and revert or let me know). Kimen8 (talk) 16:07, 3 April 2024 (UTC)