Pregnancies Exposed To Accutane Despite Risk Management Program

Armen Hareyan's picture

Despite a mandatory program designed to prevent pregnant women from being exposed to the anti-acne medication Accutane and similar medications containing isotretinoin (a known teratogen or birth defect-causing agent), 122 pregnancies were exposed during the first year of the program, known as iPledge, a report revealed.

The March of Dimes Foundation said it is evaluating the report and will carefully review any proposed changes to the program following the meeting tomorrow of the FDA's Dermatologic and Ophthalmic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee.

"It's certainly a positive step that FDA and the drug manufacturers have made this information publicly available, so that the iPledge program can be properly evaluated," said Michael Katz, M.D., senior vice president for Research and Global Programs of the March of Dimes. "Although no human system will ever be perfect, the goal is to prevent birth defects to the fullest extent possible. No woman should ever take isotretinoin while pregnant and no woman should get pregnant while taking isotretinoin. Too many pregnancies still are being exposed to this drug."


Recently, the FDA said it took steps to close a loophole in the iPledge program by warning women not to buy Accutane, or any generic forms of the drug, over the Internet, to bypass the monitoring program.

Isotretinoin, one of the most potent teratogens, is marketed under several brand names to treat severe acne that does not respond to conventional treatments. More than 1.5 million prescriptions were written annually according to 2001-2002 FDA data.

Isotretinoin is chemically related to vitamin A. Birth defects associated with isotretinoin include mental retardation, brain and heart defects. Birth defects or miscarriages can occur soon after conception, often before a woman realizes she is pregnant.

The iPledge program is administered by Covance, a company designated by the drug manufacturers and required to report to the FDA. It was modeled on the program created in 1998 to monitor and control the use of Thalomid (thalidomide).