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Warning to Botox Users: FDA Says 350 Doctors Have Counterfeit Botox

Update Date: Dec 26, 2012 02:43 PM EST
After examining the effects and safety of Botox, the FDA has approved the product as treatment for crow's feet. (Photo : REUTERS/Shannon Stapleton )

The U.S. Food and Drug Administration (FDA) have warned more than 350 medical practices that the Botox they may have received from a Canadian supplier is unapproved and could be counterfeit or unsafe to use on their patients.

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The FDA said in a letter sent last month and released 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 ensure their effectiveness or their safety.

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

In September, the agency tried to shut down Canada Drugs' website in September but was unsuccessful. It continues to investigate the company, officials said.

The FDA said doctors should buy their drugs from licensed U.S. pharmacies to avoid any risk. Actual Botox is made by Allergan Inc., based in Irvine, Calif., the AP said.

Earlier 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.

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

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