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Less than a week after a Food and Drug Administration scientist called the acne drug Accutane “a 20-year regulatory failure,” the agency announced plans Tuesday to strengthen its efforts to prevent pregnant women from taking the drug, which can cause serious fetal abnormalities.
David Graham, a scientist in the FDA’s Office of Drug Safety, told a Senate committee hearing Thursday that the agency had not done enough to ensure that pregnant women not take Accutane, which has been on the market since 1982. A voluntary program implemented in 2002 has failed to accomplish that, and an FDA advisory panel in February recommended strengthening it.
* The FDA has approved a consumer Medication Guide for Hoffmann-LaRoche’s recalcitrant acne drug, Accutane (isotretinoin), which outlines the possible risks associated with the drug’s use. Posted on the FDA’S Web site in January, the Med Guide lists birth defects and mental disorders as possible serious side effects of taking Accutane.
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