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FDA Warns Internet Companies Selling Unapproved, Mislabeled Version of Isotretinoin

BETHESDA, MD -- September 10, 2003 -- As part of its ongoing efforts to protect Americans from dangerous prescription products purchased illegally from internet sites operating in other countries such as Canada, Thailand and Mexico, the Food and Drug Administration (FDA) is formally warning a number of firms to stop their illegal sales of an unapproved, mislabeled version of the acne drug Accutane (isotretinoin). The agency believes that this illegal practice may pose a serious health risk to patients, and urges patients not to use these illegal foreign versions.

The FDA sent several warning letters to companies telling them to cease marketing these illegal drugs. These drugs included a topical (applied to the skin) gel version of accutane, which is sold only with foreign language labeling to American consumers via internet sites.

These companies sold the drug, which purports to be equivalent to accutane, without requiring a prescription. Accutane is a drug that can cause birth defects if taken by pregnant women and is subject to a restrictive distribution program known as the System to Manage Accutane Related Teratogenicity (SMART) program.

"Today’s strong action by the FDA illustrates the serious risks patients take when buying unapproved drugs from foreign sources," said Commissioner of Food and Drugs Mark B. McClellan, M.D., Ph.D. "This agency will do everything we can to protect Americans from potentially dangerous unapproved drugs sold illegally via the internet. We are particularly concerned about the risks of using products containing foreign versions of Accutane, because of the severe birth defects it may cause if taken by pregnant women, and other potential side effects associated with the use of this drug."

Under the FDA’s risk management program for Accutane, only certain physicians may legally prescribe this drug. In addition, the prescription must be filled within seven days, and it must have a yellow sticker that certifies the patient is not pregnant. Before starting the treatment regimen, the patient must be educated about the dangerous side effects associated with this drug product when it is improperly used.

The illegal Internet sale of this drug reflects the dangers that American patients face when they buy foreign versions of U.S. drugs over the Internet. These sites are inherently risky because they bypass the strong risk management program FDA has established to protect consumers.

Source: The Food and Drug Administration

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