Warnings, Columns-Drugs & Supplements, August 2005

FDA Strengthens Accutane Risk Management Program

WASHINGTON, D.C. - The Food and Drug Administration said Aug. 12 that it has approved a registration program for the acne drug accutane (isotretinoin) to prevent the use of the drug during pregnancy.

The FDA said that pregnant women or women who might become pregnant should not take isotretinoin because although highly effective in treating acne, it carries a serious risk of birth defects if taken during pregnancy.

The agency said that effective Oct. 31, wholesalers and pharmacies will have to register with iPLEDGE to obtain isotretinoin from a manufacturer. Starting Dec. …