Risks of Accutane Still Not Clear

Washington, DCThe debate over Accutane and its alleged link to inflammatory bowel disease (IBD) continues to heat up, with apparent wins for those on both sides of the debate. Some plaintiffs have won judgments and compensation for their pain and suffering, while others have seen their actions defeated or reversed on appeal. The US Food and Drug Administration (FDA) indicated at one time that there was no concern on the agency's part that the drug may have been unsafe. However, recent research appears to suggest that a connection between Accutane acne medication and IBD may indeed exist.

What is not in dispute is that Accutane is no longer available in the US after manufacturer Roche pulled the drug from the American market last year, citing ongoing and future costs of litigation. However, isotretinoin is still available in generic form by prescription. Thus, the potential threat remains.

It's a threat that a 38-year-old software engineer from Alabama knows all too well, after his colon was removed 15 years after taking Accutane for severe acne. He sued and won a judgment of $25 million in a jury trial earlier this year. The Science Letter noted on 9/7/10 that other recent Accutane medication lawsuits have netted plaintiffs a combined $56 million. Various juries have determined that Roche did not adequately warn consumers about the risks associated with Accutane.

There have also been setbacks for plaintiffs—most recently last month's reversal of a $10.5 million verdict that originally favored the plaintiff. The 8/6/10 edition of DrugInjuryWatch.com further noted that the FDA had published a determination that Accutane (isotretinoin) capsules, 10 milligrams, 20 milligrams, and 40 milligrams, were not withdrawn from sale for reasons of safety or effectiveness.

Yet in March the online edition of the American Journal of Gastroenterology published an abstract of a study that appeared to have identified an association between Accutane and ulcerative colitis. "Although cases of inflammatory bowel disease (IBD) have been reported in isotretinoin users, a causal association remains unproven," the study stated.

The study concluded that ulcerative colitis (UC) but not Crohn Disease "is associated with previous isotretinoin exposure. Higher dose of isotretinoin seems to augment this risk. Although the absolute risk of developing UC after taking isotretinoin is likely quite small, clinicians prescribing isotretinoin as well as prospective patients should be aware of this possible association."

Roche stated that the removal of Accutane from the market was not the result of any link to potential or alleged side effects. Generic competition could also have played a factor, given that isotretinoin continues to be available in generic form as Claravis, Sotret and Amnesteem. It's also available in Canada. For acne, there is little doubt that Accutane was effective: the Science Letter notes that during the 27 years Accutane was on the market, 13 million people used it and reported it as effective against severe acne 85 percent of the time. It is the question of IBD and other Accutane side effects around which the debate continues.