Drug Development

New Data Reveal Pregnancies Exposed to Accutane Despite Risk Management Program

Published in Food and Drug Law Weekly, August 17th, 2007

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...

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Source: Food and Drug Law Weekly (2007-08-17)

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