http://www.fda.gov/cder/drug/infopage/accutane/
Center for Drug Evaluation and Research, U.S. Food and Drug Administration
The 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.