What Is Accutane?
Accutane (isotretinoin) also sold under generic names Amnesteem, Claravis, and Sotret, is a prescription anti-acne medication first introduced in 1982 by the Swiss pharmaceutical firm Hoffman-LaRoche. Accutane has been the subject of extensive litigation since its introduction, leading Hoffman-LaRoche to pull it from the market in 2009, however it is still available generically.
Side effects of Accutane can include the following:
• Mental health problems, including suicidal thoughts or actions, violent acts, depression, and dissociative disorders. Between 1982 and 1998, the FDA and Hoffman-LaRoche received 170 reports of suicide, suicidal attempts, and/or suicidal thoughts in Accutane patients. While the FDA ranks Accutane highly among drugs that can cause depression or suicide, there is no evidence of a direct link, and the number of Accutane patients suffering depression or suicide is no greater than in the general population.
• Bowel diseases, including inflammatory bowel disease (IBD), Crohn’s disease, and ulcerative colitis. These conditions can cause severe cramping and bleeding, abdominal pain, and diarrhea.
• Birth defects, including serious damage to the infant’s cardiovascular and/or central nervous system, problems with the parathyroid and thymus glands, and abnormal formation of the head and skull.
In the last case, Accutane’s risk of causing birth defects is so serious that the FDA has declared Accutane a Category X drug, which means that women who are nursing, pregnant, or likely to become pregnant are banned from taking it. It is recommended that pregnant women not even touch Accutane tablets. Even a small amount of Accutane increases the risk of birth defects.
In 2006, the FDA initiated the iPLEDGE program, under which women who use Accutane or its generic forms must agree to use two forms of contraception, as well as adding their information to a government database and taking a pregnancy test every month.
Accutane has also been associated with other rare side effects, including skin reactions, damage to the liver and pancreas, bone problems, and impairment of vision or hearing.
Numerous product liability lawsuits have been filed against Hoffman-LaRoche based on Accutane’s potential to cause the conditions listed above. Plaintiffs argue that Accutane’s possible side effects are unreasonably dangerous, and/or that Hoffman-LaRoche failed to adequately warn physicians and patients of the potential dangers of taking Accutane.
Hoffman-LaRoche has countered that there is no scientific evidence that Accutane causes IBD or suicide, that they have given adequate warning of the possible side effects, and that some plaintiffs cannot prove that their injuries were linked to their use of Accutane.
Most Accutane lawsuits have been filed in New Jersey, where Hoffman-LaRoche has its U.S. headquarters. In 2005, the New Jersey Supreme Court declared Accutane cases part of a mass tort and designated a judge in Atlantic City to handle all future Accutane litigation. Federal cases against Accutane were consolidated into a multidistrict litigation in Florida in 2004.
While many suits are remain ongoing, since 2007 Hoffman-LaRoche has had to pay out at least six awards, averaging $15.5 million each, in suits alleging that Accutane caused IBD. One of these suits was overturned at the appellate level.