A PREGNANCY-PREVENTION PROGRAM IN WOMEN OF CHILDBEARING AGE RECEIVINGISOTRETINOIN

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, imp lemented a multicomponent Pregnancy Prevention Program in 1988. We rep ort the results of an ongoing survey designed to assess compliance wit h this program. Methods. Treated women enrolled in the survey through their physician, by filling out a form in the medication package, or b y calling a toll-free telephone number. They were randomly assigned to be followed by telephone or by mail. Telephone interviews were conduc ted at the start of therapy, in the middle of it, and 6 months after i t ended; mailed questionnaires were completed 6 months after therapy e nded (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 h ad been told to avoid pregnancy. At that time, approximately 54 percen t were not sexually active (of whom 37 percent used contraception) and 42 percent were sexually active (of whom 99 percent used contraceptio n); 4 percent were infertile. Among 124,216 women with completed telep hone or mail follow-up results, there were 402 pregnancies during ther apy (3.4 per 1000 courses of isotretinoin); 72 percent of the pregnant women had elective abortions, 16 percent spontaneous abortions, 3 per cent ectopic pregnancies, and 8 percent live births. Conclusions. The pregnancy rate among women receiving isotretinoin therapy was substant ially lower than that in the general population and was compatible wit h the characteristics and behavior of the enrolled women.