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Article: FDA debates more restrictions on Accutane.
- Article from:
- Drug Week
- Article date:
- March 26, 2004
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2004 MAR 26 - (NewsRx.com & NewsRx.net) -- 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 ...