Fetal exposure to oral isotretinoin: failure to comply with the Pregnancy Prevention Program.

Abstract

), an effective treatment for cystic, recalcitrant acne, is a potent human teratogen. 1 To prevent fetal exposure to the drug, the Pregnancy Prevention Program was developed in 1988 by the manufacturer and the US Food and Drug Administration and has been used in Canada since then. 2,3 As part of the program, printed material is distributed to prescribing physicians to be used in educating their female patients about the serious teratogenic effects, 4 it instructs physicians to have female patients undergo a pregnancy test and to prescribe the drug if the result is negative, and it instructs physicians to delay therapy until the second or third day of the patient’s next normal menstrual period. The program also stresses to patients the importance of using 2 forms of contraception concurrently. Female patients are asked to sign a consent form acknowledging that they have been instructed through the program, are aware of the need to use 2 forms of contraception during isotretinoin therapy and agree to undergo pregnancy testing before, during and after the therapy. 2