HEALTH & SCIENCE

FDA sets up national registry for acne drug

Some dermatologists question whether this approach will help reduce the risk of congenital anomalies posed by isotretinoin.

By Susan J. Landers, AMNews staff. Sept. 12, 2005.

Washington -- The Food and Drug Administration is requiring that physicians and patients register on a new Internet database called iPLEDGE before they can prescribe or receive the acne medication isotretinoin, also known by the brand names Accutane, Amnesteem, Claravis and Sotret.

The heightened precautions, designed to reduce the number of pregnant women exposed to the drug, will go into effect Dec. 31. The iPLEDGE site was scheduled to be opened for registrations from physicians and others this month.

The warnings associated with isotretinoin have steadily increased since the FDA's first risk-management program was instituted in 1988. Introduced in 1982, the drug has long been known to increase the risk for congenital anomalies, but its effectiveness as a treatment for severe recalcitrant nodular acne has also been unrivaled.

The FDA announced the registry requirements Aug. 12, when it also alerted doctors to watch for signs of depression or suicide among patients taking the medicine. The agency said it was continuing to monitor potential psychological side effects.

These recent actions were applauded by the March of Dimes, which estimates that at least 2,000 pregnancies among women taking the drug have been reported over the years. Roche Pharmaceuticals, the manufacturer of Accutane and a developer of the new registration program, also welcomed the FDA's approval of iPLEDGE. "The program's development has been an exemplary collaborative effort among Roche, the generic manufacturers and the FDA," according to a company statement.

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