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Health Agencies Update
March 22/29, 2006

Isotretinoin Regulations

JAMA. 2006;295(12):1364. doi:10.1001/jama.295.12.1364-c

In March, the Food and Drug Administration implemented iPLEDGE, a strengthened risk management plan for the acne drug isotretinoin. The registry program was designed as a result of concerns about exposure of fetuses to the drug. Use of isotretinoin by a woman who is pregnant or who soon becomes pregnant creates risks of miscarriage and birth defects to her fetus.

Through iPLEDGE, physicians, patients, wholesalers, and pharmacies must be registered and activated if they want to sell, prescribe, or take isotretinoin. Women prescribed isotretinoin must agree to use two separate forms of effective birth control at the same time 1 month before, while taking, and for 1 month after stopping isotretinoin and will only be able to receive up to a 30-day supply of isotretinoin at one time. More information can be found at http://www.fda.gov/cder/drug/infopage/accutane/.

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