Acne

FDA announces enhancement to isotretinoin risk management program

Published in Medical Letter on the CDC and FDA, December 26th, 2004

The U.S. Food and Drug Administration (FDA) has announced the strengthening of the risk minimization action plan (RiskMAP) for Accutane (isotretinoin) and its generic equivalents.

Isotretinoin is a drug indicated for the treatment of a specific type of severe acne (severe recalcitrant nodular acne) that is not responsive to other therapies. The goal of the strengthened RiskMAP is to reduce the risk of birth defects associated with fetal exposure to isotretinoin.

The strengthened RiskMAP reflects agency and sponsors' consideration of the recommendations from the February 2004 joint Advisory Committee of the Drug Safety and Risk Management and the...

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Source: Medical Letter on the CDC and FDA (2004-12-26)

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