What is Accutane and how does it work?
Accutane (also known as Isotretinoin), or Roaccutane as is also known in parts of the world, was discovered in 1979 when it was first given to patients with severe acne, most of whom reacted with dramatic and permanent clearing of their acne symptoms. It is a vitamin A derivative which is administered orally in pill form, normally for 15-20 weeks (3.5-4.5 months). It was originally prescribed for people with severe acne that did not respond to other treatments, but has gained in popularity in the past 25 years and is prescribed more and more frequently for less severe acne. Accutane is a serious medication which must be taken under close doctor’s supervision. Blood tests are required and side effects can be as devastating as they are widespread.
Exactly how Accutane works on a cellular level is unknown, but we do know that it affects all of the four ways that acne develops.
- It dramatically reduces the size of the skin’s oil glands (35%-58%) and even more dramatically reduces the amount of oil the skin produces (around 80%).
- Acne bacteria lives in skin oil. Since oil is so dramatically reduced, so is the amount of acne bacteria in the skin.
- It also slows down how fast the skin produces skin cells inside the pore which helps pores from becoming clogged in the first place.
- It displays anti-inflammatory properties.
Although acne may get worse within the first month on a cycle of Accutane, the ultimate results are usually dramatic. Accutane works to achieve complete or partial clearance of acne in about 95% of people who complete a cycle, regardless of whether they have inflammatory or non-inflammatory acne. The majority of people who take it see their acne effectively cured, experiencing long term remission of acne symptoms. Studies show an average relapse rate of 25%, and in these cases sometimes a second course is given. This relapse rate is dose dependent. Patients who receive a cumulative dose of 100-120mg/kg see the best results and lowest relapse rates. Patients who receive a lower dose relapse more frequently. Depending on how much the patient weighs, .5mg – 2mg/kg is usually prescribed per day.
Accutane need not be paired with other medications. For people who have problems handling Accutane, intermittent dosage is potentially an option and is being studied for effectiveness. Generic forms of Accutane may or may not be as therapeutic or safe. This is based on only one study which was performed in the UK in 2006. Out of the 14 generic brands studied, 13 failed to match Roaccutane (as it is called in the UK) in one or more tests and 11 failed in three or more tests. More studies like this one are needed to present better data on this subject.
Accutane, suicide and depression
Patients have reported depressive symptoms while taking Accutane since shortly after the drug became legal in 1982. Whether the drug caused these depressive feelings remains a subject of intense debate. There are, after all, millions of people taking the drug, and there are bound to be people experiencing depression amongst them. Despite the confusion around this topic, Roche Pharmaceuticals ®, the makers of Accutane, added a warning to its label regarding suicide and depression in 1998.
Media coverage on the topic spiked in 2000 when Michigan congressman Bart Stupak’s son BJ committed suicide while on an Accutane cycle. Research began in earnest to determine whether there is a causal link between Accutane, suicide & depression.
Quite a few studies have been conducted since. These have included large population based cohort studies, retrospective analysis studies, and relative risk estimates, performed in the United States, the UK, and Canada. The first of these studies showed no conclusive evidence to link Accutane with depression or suicide. As the studies mounted, the data continued to show no evidence of a link. The New England Journal of Medicine performed one of these studies and found, “431 cases of depression, suicidal ideation, suicide attempts, or suicide in U.S. patients treated with isotretinoin,” within a 10 year period. The article went on to note that the numbers listed do not exceed the U.S. suicide rate.
If a researcher were to examine the evidence from 2000 until 2005 he or she would likely conclude that there is no evidence linking Accutane with suicide or depression. However, as is often the case, further analysis showed limitations to many of the studies. A general overview performed in 2006 by the International Journal of Dermatology noted, “the overall lack of concrete scientific data limits any conclusion that can be drawn about a causal relationship between isotretinoin and psychiatric adverse events.”
Then, in 2006, depression related behavior was shown in mice injected with the drug. While animal studies do not necessarily reflect human models, it was somewhat intriguing. But even more provocative was a large cohort case-cross over study published in 2008 by the Journal of Clinical Psychiatry which was the first controlled study to find a correlation between Accutane, suicide & depression, albeit relatively minor.
The bottom line at this point is that we simply do not know if Accutane is linked with suicide and depression, and if so to what degree. Therefore, it is important for anyone taking Accutane to closely monitor their mental health while on the drug. If you find yourself feeling depressed or suicidal, seek help right away.
Accutane (isotretinoin) information
History
Gerald Peck and co-workers from the NIH (National Institutes of Health) in Bethesda, Maryland, first studied isotretinoin in patients with skin cell disorders. They accidentally found that it also worked on patients with severe acne. Isotretinoin was registered in 1979, released in the United States in 1982 as Accutane, and released in Europe in 1985 as Roaccutane.
Roche’s patent expired in 2002, and there are now generic forms of the drug available.
Pregnancy prevention programs
Roche started with a program called SMART (System to Manage Accutane Related Teratogenicity) in 2000, which became the iPLEDGE program in March, 2006. Female patients of childbearing age are required to use two (2) forms of birth control while on Accutane.
iPLEDGE program telephone: 1-866-495-0654
iPLEDGE program website: ipledgeprogram.com
Accutane is the #1 prescribed teratogenic (causes birth defects) medication in the United States.
Warning: Do not buy Accutane on the Internet
According to the FDA:
- “…Buying (Accutane) over the Internet bypasses important procedures to ensure that patients can take this drug safely. When these procedures are ignored, isotretinoin can cause serious and harmful side effects…”
- You should NEVER buy Accutane (isotretinoin) or any of the generic versions of Accutane without first seeing your healthcare professional.
- You should NEVER take Accutane (isotretinoin) or any of the generic versions of Accutane if you are pregnant or trying to get pregnant or could accidentally become pregnant.
- Some websites sell prescription drugs without a prescription. This is illegal and DANGEROUS.
I will personally add to this:
Buying Accutane or any other prescription over the Internet often means you will receive pills that contain little or no active ingredient, or in some cases, a different medication entirely. Buying Accutane over the Internet is not only illegal, it is potentially dangerous and is also a waste of money. I agree strongly with the FDA. NEVER buy Accutane over the Internet.
Topical Isotretinoin
Topical isotretinoin exists but does not produce the results of oral isotretinoin. It is used much less frequently and is largely of historical significance in acne treatment.
Manufacturer
F. Hoffman-LaRoche, Ltd. (also known as Roche)
340 Kingsland St.
Nutley, NJ 07110
Roche announced on July 22, 2008 that it is moving its headquarters to South San Francisco. This move should be complete by 2010.