Background: Isotretinoin is effective in treating severe acne, but it is also teratogenic. To minimize pregnancies among exposed women, the manufacturer, together with the U.S. Food and Drug Administration, implemented a multicomponent Pregnancy Prevention Program in 1988. We report the results of an ongoing survey designed to assess compliance with this program.
Methods: Treated women enrolled in the survey through their physician, by filling out a form in the medication package, or by calling a toll-free telephone number. They were randomly assigned to be followed by telephone or by mail. Telephone interviews were conducted at the start of therapy, in the middle of it, and 6 months after it ended; mailed questionnaires were completed 6 months after therapy ended (median duration of therapy, 20 weeks).
Results: Between 1989 and 1993, 177,216 eligible women enrolled in the survey. Interviews with 24,503 women within one month of enrollment revealed that 99 percent had been told to avoid pregnancy. At that time, approximately 54 percent were not sexually active (of whom 37 percent used contraception) and 42 percent were sexually active (of whom 99 percent used contraception); 4 percent were infertile. Among 124,216 women with completed telephone or mail follow-up results, there were 402 pregnancies during therapy (3.4 per 1000 courses of isotretinoin); 72 percent of the pregnant women had elective abortions, 16 percent spontaneous abortions, 3 percent ectopic pregnancies, and 8 percent live births.
Conclusions: The pregnancy rate among women receiving isotretinoin therapy was substantially lower than that in the general population and was compatible with the characteristics and behavior of the enrolled women.
PIP: Isotretinoin is effective in treating severe acne, but it is also teratogenic. To minimize pregnancies among exposed women, the manufacturer, together with the US Food and Drug Administration, implemented a multicomponent Pregnancy Prevention Program in 1988. The results of an ongoing survey designed to assess compliance with this program are reported. Treated women enrolled in the survey through their physician, by filling out a form in the medication package, or by calling a toll-free telephone number. They were randomly assigned to be followed by telephone or by mail. Telephone interviews were conducted at the start of therapy, in the middle of it, and 6 months after it ended; mailed questionnaires were completed 6 months after therapy ended (median duration of therapy, 20 weeks). Between January 1, 1989, and December 31, 1993, 177,216 eligible women enrolled in the survey. First telephone interviews were completed with 24,503 women within 1 month of enrollment. The median age of these women was 26 years, the median number of years of education was 14, and the median duration of acne was 8 years. 99% had been told to avoid pregnancy; 85% were told of the importance of using effective contraception for 1 month before starting isotretinoin. At that time, approximately 54% were not sexually active (of whom 37% used contraception); 42% were sexually active (of whom 99% used contraception); and 4% were infertile. As of June 30, 1994, 124,216 women had completed telephone or mail follow-up. There were 402 pregnancies during therapy (0.3% or 3.4 per 1000 20-week courses of isotretinoin); 46 were pregnant when therapy began, and 356 became pregnant during therapy. 290 (72%) of the 402 pregnant women had elective abortions, 63 (16%) had spontaneous abortions, 13 (3%) had ectopic pregnancies, and 32 (8%) had live births. Of the 32 liveborn infants, the survey teratologist examined 13, of whom 5 were judged to have defects compatible with the isotretinoin embryopathy. The pregnancy rate among women receiving isotretinoin therapy was substantially lower than that in the general population and was compatible with the characteristics and behavior of the enrolled women.