Acne Drug’s Fetal Risks

The U.S. Food and Drug Administration (FDA) has alerted physicians to the potentially severe psychiatric side effects that can accompany use of the popular acne drug isotretinoin (Accutane). One particularly troubling area is the medication’s effects on pregnant women and their fetuses.

While little is known about isotretinoin’s functional effects on the adult brain, its effects on fetal brain development are well documented. About one-third of fetuses exposed to the drug suffer brain abnormalities, including mental retardation. It also may cause facial deformities, heart defects, and other abnormalities, as well as a miscarriage or premature birth.

Female patients must complete and sign an informed-consent form warning them of these risks and the need to avoid pregnancy while using isotretinoin. They must agree to use two reliable methods of birth control simultaneously for one month before they can begin taking isotretinoin, while taking it, and for one month after they stop taking it.

Despite intensive pregnancy-prevention efforts, about 150 pregnancies among isotretinoin users are reported annually to the FDA. To lower this number, the agency is working with the manufacturer, Roche, to develop a program that will link isotretinoin prescribing to pregnancy-test results. This program, scheduled to start this summer, will require that all prescribers and their female patients be registered. Women will not be able to get their monthly refills without proof that they are not pregnant.