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Accutane Users Awarded $18 Million for Inflammatory Bowel Disease

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Another Accutane lawsuit has concluded

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in favor of the plaintiffs. This time, Accutane users were awarded $18 million for inflammatory bowel disease (IBD) associated with Accutane use. Roche Holding AG will pay damages to two prior users of its Accutane (isotretinoin) acne drug, according to a New Jersey ruling, wrote Bloomberg.com. It took jurors in state court in Atlantic City just six hours to find that Roche (which is based in Basel, Switzerland) officials neglected to appropriately warn both Kathleen Rossitto and Riley Wilkinson that Accutane could lead to IBD. Each plaintiff was awarded $9 million in compensatory damages, said Bloomberg.com. IBD is not the only significant adverse health effect linked to Accutane. Recently, NewsInferno wrote that another study, conducted by researchers at Tel Aviv Medical Center in Israel, found that Accutane patients were nearly twice as likely to develop an ocular adverse effect when compared to people not taking any acne medications. The complete study appears in the journal, Archives of Dermatology. Some 16 million people have taken Accutane, said Bloomberg.com, which was approved in 1982 and soon became Roche’s second-biggest selling drug. Roche, the world’s largest manufacturer of cancer drugs, pulled Accutane in 2009 following jury awards in the millions of dollars over IBD claims. Regarding two separate claims rejected by jurors in the same New Jersey court, a U.S.-based Roche spokesman said, “The company believes that the evidence at trial demonstrated that Accutane did not cause this disease and that Roche acted appropriately in providing information to the medical, scientific and regulatory communities,” wrote Bloomberg.com. Roche said it would appeal the Rossitto and Wilkinson verdicts, which followed an announcement by European regulators in which Roche was faulted for not reviewing safety issue reports and determining if those reports—involving Roche products—should be passed on to health authorities, said Bloomberg.com. On June 21, the European Medicines Agency (EMA) revealed that about 80,000 reports involving medicines marketed in the U.S. were never reviewed to determine if the reports should have been passed on to the European Union as suspected adverse reactions, said Bloomberg.com. Accutane is prescribed to treat moderate to severe acne and is the treatment of choice for acne vulgaris, a severe acne condition that typically affects teenagers and younger adults, said NewsInferno. To date, Roche has lost nine of 13 lawsuits brought about by prior Accutane uses since 2007. As of earlier this year, there were some 2,441 Accutane IBD lawsuits pending in a New Jersey mass tort litigation that began five years ago. Over the fall, more than 800 lawsuits were filed in the Accutane litigation; more cases are expected. In addition to IBD links, the recent study found that Accutane dries the eyes, robbing them of lubricant and increasing risks for infection and other serious ocular maladies, said NewsInferno. Adverse effects were usually caused by changes to the eyelids during Accutane treatment, said NewsInferno. Approved by the Food & Drug Administration (FDA) in 1982, Accutane has long been the subject of controversy. In the late 1980s, Accutane was linked to severe birth defects and has since been linked to psychiatric problems, including hundreds of cases of suicide in the United States. Accutane has also been linked to liver, kidney, central nervous system, and pancreatic problems, as well as problems with the cardiovascular, musculoskeletal, and autoimmune systems, said NewsInferno. The rare and dangerous skin disorder, Stevens-Johnson syndrome, which can be fatal if untreated, has been tied to Accutane.

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