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Health Agencies Update
September 28, 2005

Isotretinoin Risks

JAMA. 2005;294(12):1481. doi:10.1001/jama.294.12.1481-a

The Food and Drug Administration (FDA) has approved a strengthened distribution program aimed at preventing use of isotretinoin by pregnant women. Taken to treat severe nodular acne, isotretinoin carries a significant risk of birth defects if taken during pregnancy.

Under the manufacturers’ new program, called iPLEDGE, physicians and patients must register and agree to accept specific responsibilities before receiving authorization to prescribe or use the drug. For example, patients must complete an informed consent form and obtain counseling about the risks and safe use of the drug, and women of childbearing age must comply with required pregnancy testing. Wholesalers and pharmacies must also comply with specific program requirements to distribute and dispense the product.

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