FDA sets up Accutane warning web site

The US Food and Drug Administration is launching a special web page to warn consumers about the dangers of buying isotretinoin on-line. The drug is approved for the treatment of severe recalcitrant nodular acne that does not respond to antibiotics. Improperly used, it can cause severe side effects, including birth defects, says the FDA, noting that serious mental health problems have also been reported with the product's 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 on-line investigation for the drug under any one of its four names (isotretinoin is sold as Accutane by its discoverer, Swiss drug major Roche, 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 on-line come from legitimate pharmacies.

The FDA and the manufacturers of isotretinoin have put in place special safeguards to reduce the risks of the drug, including a strict distribution program, called iPLEDGE. The aim of this is to ensure that women using isotretinoin do not become pregnant, and that women who are pregnant do not use isotretinoin. The product is available only at a pharmacy that is registered for this distribution program. Additionally, the program is designed to prevent the sale of isotretinoin over the Internet.