Continued occurrence of Accutane-exposed pregnancies.
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.
Honein
M A
MA
National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention, Atlanta, Georgia 30341-3724, USA. mrh7@cdc.gov
Paulozzi
L J
LJ
Erickson
J D
JD
D000014:Abnormalities, Drug-Induced / Q000453:epidemiology* / Q000209:etiology / Q000517:prevention & control*; D000022:Abortion, Spontaneous / Q000139:chemically induced; D000152:Acne Vulgaris / Q000188:drug therapy; D000293:Adolescent; D000328:Adult; D003267:Contraception; D003268:Contraception Behavior; D000075202:Contraindications; D005260:Female; D006801:Humans; D015994:Incidence; D015474:Isotretinoin / Q000009:adverse effects*; D007641:Keratolytic Agents / Q000009:adverse effects*; D010353:Patient Education as Topic; D011247:Pregnancy; D011248:Pregnancy Complications / Q000139:chemically induced; D011256:Pregnancy Outcome; D011261:Pregnancy Trimester, First; D013997:Time Factors
D007641:Keratolytic Agents; D015474:Isotretinoin