Continued occurrence of Accutane-exposed pregnancies

Abstract

Background: Accutane a teratogenic prescription drug licensed to treat severe, recalcitrant nodular acne. First-trimester pregnancy exposure can cause major birth defects. The manufacturer began a Pregnancy Prevention Program (PPP) in 1988; however, exposed pregnancies continue to occur. In 1996, the manufacturer began a direct-to-consumer advertising campaign, raising concerns of more exposed pregnancies.

Methods: We examined trends in Accutane use by reproductive-aged women. We also interviewed a series of 14 women in California who had recent Accutane-exposed pregnancies to identify opportunities for prevention.

Results: The estimated number of Accutane prescriptions for reproductive-aged women has more than doubled in the past 10 years; it is the most widely used teratogenic drug in the United States, with approximately 2.5 per 1,000 reproductive-aged women exposed to Accutane in 1999. One-half of the women interviewed reported seeing an advertisement for prescription acne treatment before taking Accutane. Eight of the 14 women used no contraception at the time of the exposed pregnancy; 13 of the 14 women did not use two forms of contraception. Four of the 14 women did not have pregnancy tests before starting Accutane. None reported seeing all PPP components, and four saw only the information on the pill packet. These 14 pregnancies resulted in four live infants who had no apparent birth defects, one live-born infant with multiple defects, four spontaneous abortions, and five induced abortions.

Conclusions: The increase in Accutane use observed among females may be exacerbated by advertising. Physicians and patients must use more caution with teratogenic prescription drugs. Published 2001 Wiley-Liss, Inc.