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Health & Medicine Week

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Acne



FDA debates more restrictions on Accutane



March 22nd, 2004

Critics are calling for major new curbs on who can get a prescription for the acne drug Accutane, after voluntary restrictions failed to reduce the number of pregnancies among women using the birth defect-causing medicine.

The U.S. Food and Drug Administration (FDA) is asking its scientific advisers what additional safeguards are needed to battle the birth-defect problem that Accutane has posed since it first hit the market in 1982.

One of those advisers charged the FDA missed a crucial opportunity for better safeguards three years ago - by ignoring this same panel's recommendation that Accutane be sold only to female patients enrolled in a national...


Source: Health & Medicine Week (2004-03-22)

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