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Article: FDA Weighs Acne Drug Restrictions.(United States. Food and Drug Administration recommend stronger control off Accutane)(Brief Article)(Statistical Data Included)
- Article from:
- Medical Letter on the CDC & FDA
- Article date:
- October 8, 2000
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2000 OCT 8 - (NewsRx.com) --
Women and their doctors may soon face far tougher restrictions on who can take the acne drug Accutane, which can cause serious birth defects.
Accutane is highly effective at fighting disfiguring acne, but it can cause brain, facial, and other birth defects. Thus, Accutane's maker urges women to undergo two pregnancy tests before taking the first dose, and to use two forms of birth control.
But nobody enforces those recommendations, and 1,995 women have gotten pregnant while using Accutane since it hit the market in 1982. Most of those pregnancies ended in abortion, but of the 383 babies born, 162 had birth defects. ...