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Isotretinoin (Accutane) is an effective treatment for severe, recalcitrant nodular acne, but it causes severe congenital anomalies; it is the most widely used teratogenic medication in the U.S. In 1988, the manufacturer initiated a pregnancy prevention program urging women who were taking this drug to either abstain from sexual intercourse or use 2 simultaneous forms of contraception. In 1996, the manufacturer initiated a direct-to-consumer advertising campaign that provided no warning about teratogenicity. CDC researchers used national prescription drug databases to examine trends in isotretinoin exposure and interviewed 14 women who took isotretinoin during pregnancy or became pregnant during treatment.
The authors estimated that 2.5 of ev…