March 29, 2007
FDA Web site warns against online Accutane sales
The FDA has launched a Web site designed to warn consumers about the dangers of purchasing Roche’s acne drug Accutane (isotretinoin) and its generic equivalents over the Internet. Web sales of the drugs are already illegal, however, the FDA said, some consumers have turned to the Internet to circumvent a federal program designed to control access to the drug. The agency said the Web page, http://www. fda.gov/buyonline/accutane, will be positioned as a search result on Google and other search engines so that it is highly visible when a consumer initiates an online search for the drug under any one of its four names. Isotretinoin is also sold by generic manufacturers Genpharm, maker of Amnesteem which is distributed by Mylan/Bertek; Ranbaxy Pharmaceuticals, maker of Sotret; and Barr Laboratories, maker of Claravis. The FDA Web page warns that the drug “should only be taken under the close supervision of a physician or a pharmacist” and provides links on how 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, director, FDA’s Center for Drug Evaluation and Research. Last March, the FDA and manufacturers of isotretinoin initiated a distribution program, dubbed iPLEDGE, placing safeguards on sales of the drug to women who are pregnant. Women must use two forms of birth control and get two negative pregnancy tests before their initial Accutane prescription, and show proof of another negative pregnancy test before each monthly refill. Isotretinoin has been linked to severe birth defects as well as mental health problems and liver damage. The drug is approved to treat severe acne in patients that do not respond to other treatments.