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Article: Accutane risk management program strengthened.(Brief Article)
- Article from:
- FDA Consumer
- Article date:
- January 1, 2002
CopyrightCOPYRIGHT 2002 U.S. Government Printing Office. 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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The Food and Drug Administration has announced changes that strengthen a risk management program regarding pregnancy and a drug used to treat severe acne. Accutane (isotretinoin) is a drug approved to treat the most serious form of acne--a type that is painful, permanently disfiguring, and does not respond to other acne treatments. Accutane is very effective, but its use carries significant potential risks, including birth defects and even fetal death.
The new risk management program is called S.M.A.R.T., the System to Manage Accutane-Related Teratogenicity. "Teratogen" refers to any substance with the potential to cause birth defects. S.M.A.R.T. was developed in ...