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Health Agencies Update
February 20, 2002

More Stringent Rules on Accutane

Author Affiliations

Copyright 2002 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.2002American Medical Association

JAMA. 2002;287(7):832. doi:10.1001/jama.287.7.832

In an effort to prevent drug-related birth defects, the US Food and Drug Administration has made it more difficult for physicians to prescribe Accutane (isotretinoin). In a January 9 letter to consumers and health care providers, Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, wrote that "a significant proportion of fetal exposures have occurred because patients were already pregnant" when they began Accutane therapy. In bold print, she added, "These events are entirely preventable."

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