Adult acne treatment drug Accutane to be prescribed differently

MYNIPPON had highlighted that Accutane may not be the safest drug for treatment of acne as pointed by Dr. David Graham, an expert at the FDA. While Dr. Graham is otherwise being criticized and harassed by the FDA for his exposure of the mishandling of Vioxx recall by the FDA, his comments on Accutane are apparently accurate.

The FDA 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 new program will include an appropriately timed and documented negative pregnancy test prior to dispensing Accutane which can have disastrous consequences if administered to pregnant women.

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