WASHINGTON — Federal regulators have warned more than 350 medical practices that Botox they may have received from a Canadian supplier is unapproved and could be counterfeit or unsafe.
The Food and Drug Administration said in a letter sent last month and 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.
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.