FDA to Medical Practices: Beware Unlicensed Botox

Federal regulators are warning medical practices about unauthorized Botox that may be unsafe.

The U.S. Food & Drug Administration (FDA) issued the warning to some 350 medical practices that they may have received unauthorized, dangerous, and unlicensed versions of the wrinkle reduction injections, said My Fox Atlanta. Because the so-called Botox is not regulated and is not licensed, said the FDA, it warns that not only might the fake Botox be unsafe, it might also be ineffective.

According to the agency, suppliers that are owned by a pharmacy called Canada Drugs are shipping the unlicensed Botox, said My Fox Atlanta. As we’ve explained, Genuine Botox is made by Allergan Inc., in Irvine, California.

The alert, which was sent by the agency late last year, warned the physician practices that they may be in the possession of “unapproved medications, including unapproved versions of Botox,” from a pharmacy owned and operated by Canada Drugs, said My Fox Atlanta. In its letter, the FDA listed those doctors’ names and locations, which may have purchased the unlicensed Botox.

As we previously wrote, the FDA noted that Canada Drugs had previously been linked to shipping unapproved and counterfeit cancer drugs.

The agency had also warned physicians about purchasing medications from sources that were not licensed, U.S. pharmacies. This was the fifth such warning the FDA made in 2012 over foreign suppliers providing unapproved drugs, CBC News previously said.

Last February, the FDA warned 19 medical practices that they had received a counterfeit version Avastin, a cancer treatment. The FDA issued similar warnings about counterfeit Avastin and Altuzan—a different brand of the same medication as Avastin—on three occasions. Those alerts primarily targeted drugs distributed by Canada Drugs.

In October, the FDA ordered operators of some 4,100 web sites to cease selling unapproved medications to U.S. consumers. Most sites were operated by Canada Drugs, said CBC News previously.

Earlier last year, the FDA issued a warning about counterfeit Adderall. The counterfeit version of Teva Pharmaceutical Industries’ Adderall tablets were purchased on the Internet, contained fake active ingredients, and were meant to imitate Teva Adderall 30 milligram tablets. Adderall is a prescription medication approved to treat attention deficit hyperactivity disorders (ADHD) and narcolepsy, and is classified as a controlled substance.

Many are concerned that as drug counterfeiters fine-tune their practices, global health regulators are ill-prepared to prevent fake drugs from reaching patients The law has not caught up with counterfeiters and is not expected to catch up for years to come.

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