Accutane Continues to Cause Birth Defects

July 2007

The iPLEDGE program, guided by the Food and Drug Administration to prevent birth defects in the unborn children of women taking the acne drug Isotretinoin, has nearly no affect in stopping pregnancies. The past year has seen 122 women become pregnant while registered with iPLEDGE, about the same number of pregnancies reported before the program became mandatory last year.

Isotretinoin is sold under the brand names Accutane, Amnesteem, Claravis, Sotret, and more. It is known to cause severe brain defects, heart defects, mental retardation, and other complications in children who are conceived within 30 days of the mother’s last dose of the drug.

The iPLEDGE program allows manufacturers to continue marketing Isotretinoin despite its risk of causing birth defects. Over 135,000 women of childbearing age registered with iPLEDGE in its first year. Of the 122 women, 78 were taking the drug when they became pregnant. There were 10 users that were already pregnant when they began use of isotretinoin, two of whom falsified documents to get their prescriptions.