Science Mixed on Accutane Side Effects but Juries Side with Plaintiffs

Philadelphia, PARecent studies have provided mixed results on the risk of Accutane side effects. Some have identified a link between Accutane and inflammatory bowel disease; other studies disagree. Although Accutane has been removed from the market, generic Accutane (known as isotretinoin) is still available, causing some concern that more patients might be exposed to a risk of IBD.

One study that supported the link between Accutane and IBD was published in the American Journal of Gastroenterology in April 2010. The study found that Accutane users were four times more likely than non-users to develop ulcerative colitis within a year of taking the medication.

Researchers found that the risk of ulcerative colitis tended to increase with higher daily doses of the medication. No such link was found with Crohn's disease.

More research is still needed to strengthen the link between Accutane and IBD, researchers say. It is still not known how isotretinoin might cause IBD. Researchers also note that the overall risk of developing IBD after taking Accutane is small.

IBD is a group of digestive disorders that includes ulcerative colitis and Crohn's disease. Patients with IBD sometimes require surgery to remove part or all of the colon.

Roche Pharmaceuticals has defended its drug, saying there is no strong evidence proving Accutane causes IBD. The drug was removed from the market in 2009, but Roche said it was pulled because of competition from generic versions of the drug and the costs of personal injury lawsuits.

Meanwhile, two recent studies support Roche's argument that its acne medication is safe. Both studies found that there was no clear relationship between the use of isotretinoin and the development of IBD. One researcher noted, however, that the lack of an association in the studies only shows that there is not enough evidence to prove Accutane causes IBD; it does not prove that there is no link between the two.

Despite conflicting evidence in scientific literature concerning Accutane, juries have tended to side with plaintiffs, giving awards to plaintiffs in all seven lawsuits that have gone to trial so far. One award was reversed on appeal.