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New FDA Web Page Warns Against Buying Accutane Online

April 6, 2007

Dermatology patients should avoid purchasing Roche's Accutane or its generic equivalents over the internet, according to safety warnings on a new FDA website detailing the dangers of buying the drug online.

The new web page, www.fda.gov/buyonline/accutane, warns consumers that isotretinoin, the active ingredient in Accutane, can cause severe health complications such as birth defects and serious mental health problems. It said the drug should only be taken under the close supervision of a physician or a pharmacist.

Purchasing this product online could circumvent certain safety protocols, according to the FDA. The agency fears consumers may unknowingly purchase versions of the drug that may contain dangerous ingredients, be counterfeit, be improperly labeled or be shipped incorrectly.

In line with a wider safety effort aimed at lowering the risks associated with isotretinoin, the new web page warning coincides with iPledge, a strict drug distribution plan implemented last year where both doctors and patients are required to register prior to receiving authorization to prescribe or use the drug.

Under the program, patients must be registered in iPledge by the doctor prescribing isotretinoin and sign consent forms that explain the potential risks of the drug. They must agree to monthly doctor visits during treatment.