FDA warns counterfeit botox may have been shipped to 350 U.S. clinics


WASHINGTON Botox and other medications made by foreign suppliers may have been received by more than 350 U.S. medical practices, the Food and Drug Administration warned doctors.

The FDA said in a letter sent last month, which was released publicly last week, that batches of the wrinkle treatment shipped by suppliers owned by pharmacy Canada Drugs have not been approved by the FDA and that the agency cannot assure their effectiveness or their safety.

The FDA said Canada Drugs was previously tied to shipping unapproved and counterfeit cancer drugs.

The agency warned doctors about buying drugs from sources other than licensed U.S. pharmacies. It is the fifth warning the agency has made this year about foreign suppliers providing unapproved drugs.

"Medical practices that purchase and administer illegal and unapproved medications from foreign sources are placing patients at risk and potentially depriving them of proper treatment," the FDA said in a Dec. 19 statement.

In February, the agency warned 19 medical practices that they had received a counterfeit version of the cancer drug Avastin. On three more occasions the FDA issued similar warnings about counterfeit Avastin and Altuzan, another brand name for the same drug. The alerts were also primarily targeted at drugs distributed by Canada Drugs.

A request for comment from the drug distributor was not immediately returned.

Drug shortages increased the financial incentives for some pharmacies to provide counterfeit or illegally imported drugs. The drugs subject to warnings have all been injectable treatments typically distributed through medical practices and not directly to patients.

In October, the FDA ordered operators of about 4,100 websites to immediately stop selling unapproved medications to U.S. consumers. The vast majority of those sites were operated by Canada Drugs. The site was still operating Friday.

Genuine Botox is made by Allergan Inc., based in Irvine, Calif. Avastin is made by Roche Holding AG's Genentech unit.

The drug is made from a toxin that can be used in small doses to temporarily remove facial wrinkles and also treated medical conditions like cervical dystonia, a neurological disease that causes severe muscle contractions in the neck and shoulder.

The list of all medical clinics sent letters alerting them of the potential risk could be found on the FDA website.

In July, CBS News Chief Investigative Correspondent Armen Keteyian reported that at least 79 U.S. medical practices purchased drugs from foreign or unlicensed suppliers, potentially putting patients at risk.

His investigationfound counterfeit Avastin in the U.S. sold by companies in the Barbados, the U.K., Denmark, Switzerland and Egypt.

Keteyian reported the main motivating factor behind these clinics is money, because foreign drugs are much cheaper than U.S. drugs. For example, Avastin could be $600 cheaper than the price charged by U.S. manufacturers, he said.