Dermatologist Group Says Accutane Health Risks Outweighed by Benefits

An organization representing U.S. dermatologists say that they believe that the potential risk of bowel problems and suicide from side effects of Accutane (isotretinoin) are outweighed by the benefits provided by the drug in fighting severe acne. 

In an updated position statement published to its website last week, the American Academy of Dermatology Association (AADA) called Accutane and generic isotretinoin critically important in the treatment of severe acne. The statement cast doubts on studies and claims that have linked Accutane with inflammatory bowel disease (IBD) and an increased risk of suicide.

Accutane (isotretinoin) has been used by more than 16 million people worldwide since it was first introduced in the early 1980s as a treatment for severe acne. Roche discontinued the drug in the United States in June 2009, citing the increased costs associated with Accutane litigation over alleged health risks associated with the medication. However, a number of generic Accutane versions remain available under names such as Claravis, Sotret, Amnesteem and generic isotretinoin.

More than 1,600 people are currently pursuing an Accutane lawsuit against Roche over severe bowel problems allegedly caused by the medication. The complaints involve allegations that the drug maker failed to adequately research their medication or warn users about the risk of debilitating bowel problems from Accutane, such as ulcerative colitis and Crohn’s disease. The company has lost all six Accutane bowel disease trials that have reached a jury so far, with verdicts totalling $56 million.

In April, a study published in the American Journal of Gastroenterology found that Accutane side effects quadruple the risk of ulcerative colitis. Researchers found that not only were those taking Accutane four times more likely to develop ulcerative colitis, but they also determined that the chance of developing the bowel disorder rose in relation to the size of the Accutane dose, strengthening the evidence of a causal relationship.

In November, an Accutane suicide study in the British Medical Journal suggested that there may be a part of the population which is more likely to commit suicide after taking Accutane. However the report concluded that most Accutane suicides were due to depression over severe acne.

The AADA said that the evidence presented so far had not convinced the organization of Accutane bowel risks or that the medication itself poses a suicide risk, instead indicating that any increased suicide risk is most likely due to the psychological effects of acne.

“The Association concludes that the prescription of isotretinoin (Accutane) for severe nodular acne continues to be appropriate as long as prescribing physicians are aware of the issues related to isotretinoin use, including IBD or psychiatric disturbance, and educate their patients about these and other potential risks,” wrote the American Academy of Dermatology in their position statement. “Physicians also should monitor their patients for any indication of IBD and depressive symptoms.”