US: Flexibility urged in rules for acne drug use

August 2, 2007 00:35


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US health advisers are urging slightly more flexibility in rules designed to prevent pregnancies among women taking an acne drug that has caused birth defects - even though women taking the drug still are getting pregnant. Advisers to the Food and Drug Administration decided Wednesday that minor changes would ease access to Accutane and its generic competitors without further increasing those troubling pregnancies. There were 122 pregnancies in the program's first year and another 37 in the four months since, administrators of the privately run program told the panel. The program lost track of 35 of the women who became pregnant. Most of the rest of the pregnancies, 54, ended in abortion, and an additional 17 women miscarried. The one child known to have been born so far escaped birth defects, and officials are watching to see what happens with 15 continuing pregnancies.

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