Skin Conditions
Accutane (isotretinoin) was a popular prescription drug sold from 1982-2009 to treat patients with severe acne that was unresponsive to traditional treatments. However, since the introduction of the drug, patients have reported harmful adverse effect of the drug including severe birth defects; mental health problems including depression, suicidal thoughts, and psychosis; inflammatory bowel disease (IBD) including ulcerative colitis and Crohn's disease; pancreatitis; elevated triglycerides; liver damage; bone problems; impaired vision and hearing; and more.
By the time Roche stopped selling Accutane in 2009, hundreds of lawsuits had already been brought by people citing a range of illnesses they claim they developed because of taking Accutane. Generic forms of isotretinoin remain on the market (Amnesteem, Claravis, and Sotret) and have also been the subject of ongoing lawsuits.
Many of the federal lawsuits over Accutane and its generic forms were consolidated in multidistrict litigation (MDL) in the Middle District of Florida. Because the the drug's maker Hoffmann-La Roche ("Roche") is located in New Jersey, the majority of state lawsuits are filed in New Jersey. In 2005, the New Jersey Accutane cases were consolidated and transferred to the Atlantic County Superior Court. Since 2007, Roche has lost six Accutane jury trials alleging the drug causes IBD, although at least one has been overturned by an appellate court and the company is appealing the others. Recently, Roche has success in defending itself based on the uncertainty of the clinical evidence linking Accutane to mental problems and IBS. Although the FDA and the drug maker had received many reports of suicide, suicide attempts, or suicidal ideation (suicidal thoughts) in patients taking Accutane, the rate of reported cases of depression and suicide among Accutane users is no greater than that in the general population. Additionally, the association of isotretinoin to IBD has also come under doubt. In 2014, Roche lawyers successfully reversed a $10 million verdict against it in New Jersey by presenting the results of 6 epidemiological studies from 2009-2013, all of which showed no association between Accutane (isotretinoin) use and IBD or an inconclusive result. The dangers of isotretinoin to pregnant women, however, are not disputed. Isotretinoin is classified as a "Category X" drug, effectively prohibiting the use of the drug by pregnant women. Exactly nine months from the time Accutane went on the market, the FDA and Roche began receiving reports of serious birth defects. In 1985 the FDA required the maker of Accutane to use a black box warning on the package inserts of Accutane -- the strongest warning FDA can require. The black box warning for Accutane warns that isotretinoin must not be used by females who are or may become pregnant and that there is an extremely high risk that severe birth defects will result if pregnancy occurs while taking isotretinoin in any amount, even for short periods of time. If females do choose to use isotretinoin, the FDA requires participation in the iPLEDGE Program, which restricts the drug to young women who have not started menstrual periods, women who have had a tubal ligation, and women who comply with strict pregnancy testing and contraceptions requirements. Due to the increasing availability of generic forms of isotretinoin on the internet, the FDA has also issued a warning against online purchases because they are not part of the iPLEDGE distribution program. [1] Alston, J. "Roche Defends Accutane Against New Evidence in NJ Retrial", Law360 (March 7, 2014). [2] U.S. Judicial Panel on Multidistrict Litigation, In Re: Accutane (Isotretinoin) Products Liability Litigation, Case MDL No. 1626 (10/01/2012). [3] FDA, Isotretinoin (marketed as Accutane) Capsule Information (10/22/2010). Alerts |
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