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Article: FDA committees rule on Accutane. (Food and Drug Administration)
- Article from:
- The Network News
- Article date:
- July 1, 1990
- Author:
CopyrightCOPYRIGHT 1990 National Women's Health Network. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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On May 21, Board member Adriane Fugh-Berman presented testimony on behalf of the Network on accutane before a joint meeting of the Dermatology and the Fertility and Maternal Health Drugs Committees (see accompanying testimony). Accutane is a drug effectively used for treating recalcitrant cystic acne, a long-lasting and disfiguring condition. Accutane also causes birth defects, affecting one out of four exposed pregnancies. Concerned with the risk of fetal malformation, the Committees met to review and discuss: 1) if efforts by the drug manufacturer, Roche Dermatologics, to inform physicians and patients of the risks of Accutane have been successful; and 2) if the FDA ...