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FDA NEWS RELEASE

FOR IMMEDIATE RELEASE
P07-53
March 28, 2007

Media Inquiries:
Susan Cruzan, 301-827-6242
Consumer Inquiries:
888-INFO-FDA


FDA Launches Web Page Warning Against Buying Accutane And Its Generic Versions Online

The U.S. Food & Drug Administration (FDA) is launching a special Web page to warn consumers about the dangers of buying isotretinoin (Accutane) online.  Isotretinoin is a drug approved for the treatment of severe recalcitrant nodular acne that does not respond to antibiotics. Improperly used, isotretinoin can cause severe side effects, including birth defects. Serious mental health problems have also been reported with isotretinoin use.

The Web page, http://www.fda.gov/buyonline/accutane, will be positioned as a search result on Google and other search engines when a consumer initiates an online search for the drug under any one of its four names (Isotretinoin is sold under the brand name of Accutane and in generic versions called Amnesteem, Claravis, and Sotret.) The web page warns that the drug "should only be taken under the close supervision" of a physician or a pharmacist, and provides links to helpful information, including ways to check that drugs purchased online come from legitimate pharmacies.

"This Web page is yet another step we're taking to ensure the safe use of a drug that can provide significant health benefits when used properly, but that can also cause very serious side effects if used without supervision of a health professional," said Steven Galson, M.D.,M.P.H., Director, FDA's Center for Drug Evaluation and Research.

FDA and the manufacturers of isotretinoin have put in place special safeguards to reduce the risks of isotretinoin, including a strict distribution program, called iPLEDGE. The aim of the distribution program is to ensure that women using isotretinoin do not become pregnant, and that women who are pregnant do not use isotretinoin. Isotretinoin is available only at a pharmacy that is registered for this distribution program. Additionally, the distribution program is designed to prevent the sale of isotretinoin over the internet. Dispensing must comply with the agency's risk management requirements.

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