FRIDAY, Feb. 24 (HealthDay News) -- The U.S. Food and Drug Administration (FDA) is moving forward with an isotretinoin risk management program called iPLEDGE designed to prevent women from becoming pregnant while taking the medication. On March 1, only prescribers registered and activated under iPLEDGE will be able to prescribe Accutane and only patients similarly enrolled will be able to receive the drug.
The iPLEDGE program is a cooperative effort between the FDA and the Isotretinoin Product Manufacturers Group designed to track prescribers and users of the drug to ensure its safe use.
However, the American Academy of Dermatology believes there are still numerous flaws and inconsistencies in the program, which were pointed out by practicing dermatologist Diane Thiboutot, M.D., before the FDA's Drug Safety and Risk Management Drugs Advisory Committee on Feb. 10.
"The 15,000 physician members of the American Academy of Dermatology Association express serious disappointment in the failure of the U.S. Food and Drug Administration to postpone the mandatory March 1, 2006, start date of the iPLEDGE program," wrote Clay J. Cockerell, M.D., president of the American Academy of Dermatology Association, in a statement.
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