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FDA Sends Letters To 350 Clinics Possibly Using Unapproved Versions Of Botox

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LOS ANGELES ( —The U.S. Food and Drug Administration sent letters to 350 medical practices last month alerting them they may have received unapproved medications from a foreign supplier.

The medications, including unapproved versions of Botox, could be counterfeit, contaminated or unsafe to patients, authorities said in a statement released Dec. 19.

On Nov. 30, the FDA alerted the practices who may have received medications from foreign suppliers owned and operated by Canada Drugs, also known as Quality Specialty Products (QSP), A+ Health Supplies, QP Medical, Bridgewater Medical or Clinical Care.

“The manufacture and handling of these products may not be of suitable quality to ensure safety or efficacy, and the products have not been proven to be safe and effective pursuant to FDA standards. FDA is very concerned that products distributed by these suppliers may cause harm to patients, because they may be unsafe or ineffective,” the letter stated.

Dr. Peter B. Fodor, a Century City plastic surgeon and an expert on Botox, said using a non-FDA approved injectable can be dangerous.

“When it comes to Botox, this is a very, very potentially poisonous material…it’s an agent used in chemical warfare and it can paralyze somebody permanently or it can paralyze your diaphragm so you cannot breathe,” he said.

This is the sixth time in 2012 the FDA has issued letters to medical practices that purchased unapproved medications from foreign suppliers.

For a list of doctors who received last month’s letter, click here.

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