July 16, 2001 - Lawsuits: Acne drug dangerous
Families of suicide victims who used Accutane are fling lawsuits in federal courts around the country. Since June 30, the Food and Drug Administration has reported 83 cases of suicide in the United States from persons who were using Accutane. 42 suicides outside the United States have also been reported. The FDA believes that any data linking Accutane to suicide is "inconclusive." Since 1998 the manufacture of Accutane, Roche Pharmaceuticals, has included a label warning its users that suicide was a potential, rare side effect. The lawsuits claim, however, that the drugmaker and doctors have downplayed the alleged dangers and that not all prescriptions contain the updated warnings.
"At one point, they were advertising that the product had the psychiatric benefits - - if your acne got better, you'd be less depressed - - when in fact the FDA was requiring that they warn specifically that Accutane could cause depression or suicide in some users. Roche made a product that was defective and unreasonably dangerous," said Paul Smith, a Texas lawyer who specializes in pharmaceutical litigation.
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