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Accutane

This is a settlement for the Drugs/Medical Devices lawsuit.

Newark, NJ: (Jun-19-07) Andrew McCarrell, 36, filed a lawsuit against the makers of Accutane, Roche, after undergoing multiple surgeries, including having his colon removed, after taking the drug in 1995. A New Jersey Superior Court jury recently awarded over $2.5 million to the Alabama man who claimed that the company's acne drug caused his inflammatory bowel disease. The case is the first of the nearly 400 US lawsuits involving Accutane. The jury awarded McCarrell $2.5 million in damages and $119,000 to cover medical expenses.

Accutane was approved by the FDA in 1982 for severe, recalcitrant acne, a serious and debilitating condition that causes cysts, scarring and disfigurement. Since its approval, the drug's label carried a warning that it should not be used by pregnant women or women who might become pregnant. In 2005, the FDA approved safety labeling revisions for Accutane to inform patients of a mandatory risk management program.

From 1982 to May 2000 the FDA had determined that Accutane was associated with 147 suicides and hospitalizations for depression. By 2002, the FDA had confirmed 173 cases of suicide among persons taking Accutane, since its introduction in 1982. [INJURY BOARD: ACCUTANE SETTLEMENT]


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Published on Jun-19-07


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