The FDA launched a Web site warning of the dangers of purchasing Roche’s acne drug Accutane (isotretinoin) or any of its generic equivalents over the Internet.
The agency said the Web page, 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 sold by generic manufacturers: Genpharm, maker of Amnesteem, distributed by Mylan/Bertek; Ranbaxy Pharmaceuticals, maker of Sotret; and Barr Labs, maker of Claravis. Although Web sales of isotretinoin is illegal, some consumers have turned to the Internet to circumvent a federal program designed to control access to the drug.
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.
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.