Talk:Isotretinoin

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: <http://www.pnas.org/content/98/12/6662.abstract>. 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: <http://www.nature.com/jid/journal/v126/n10/full/5700418a.html> —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 PMID 6233335. "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

• First two external links
• reference 9

For medication guide i suggest <http://www.fda.gov/downloads/Drugs/DrugSafety/ucm085812.pdf>