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Published on Jul 31, 2007 by Edgar Snyder

Accutane Continues to Cause Birth Defects


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.

Please note: All of our lawyers are licensed to practice in the state of Pennsylvania. We also have lawyers licensed to practice in Maryland, Ohio, and West Virginia, and we associate with experienced attorneys in other states. In addition, all drug-related litigation may involve co-counsel.

Source: "Users of birth defect-causing acne drug still getting pregnant." By Lauran Neergaard. Associated Press. July 31, 2007.
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