The FDA is alerting physicians to the strengthened risk management program for isotretinoin (Accutane, Hoffmann-La Roche Inc, Nutley, NJ), an approved treatment for severe nodular cystic acne. To further protect patients against the drug's risks, which include birth defects and fetal death, the manufacturer has developed in consultation with the FDA a comprehensive program designed to ensure that no woman should begin Accutane therapy if she is pregnant and no pregnancies should occur while the patient is taking the drug.
Schwetz BA. Risk Management of Accutane. JAMA. 2002;287(5):578. doi:10.1001/jama.287.5.578