Adverse Drug Reaction

Agency strengthens risk management program for Isotretinoin

Published in Medical Letter on the CDC and FDA, September 18th, 2005

The U.S. Food and Drug Administration (FDA) announced approval of a strengthened distribution program for isotretinoin, called iPLEDGE, aimed at preventing use of the drug during pregnancy.

Women who are pregnant or who might become pregnant should not take the drug. Isotretinoin (Accutane and its generics) is a highly effective drug for severe recalcitrant nodular acne, but it carries a significant risk of birth defects if taken during pregnancy.

The manufacturers are implementing a program that requires registration in iPLEDGE by doctors and patients who agree to accept specific responsibilities before receiving authorization to prescribe or use...

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Source: Medical Letter on the CDC and FDA (2005-09-18)

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