FDA warns websites selling unapproved Botox for cosmetic purposes – National

Associated Press – U.S. health regulators on Wednesday sent warning letters to 18 websites selling counterfeit or unapproved versions of Botox and similar injectable drugs commonly used to smooth wrinkles.

The Food and Drug Administration said it is taking action after receiving reports of injuries related to the product, including toxic side effects.

Botox is a diluted and purified version of Clostridium botulinum, one of the most toxic substances in the world. This ingredient works by temporarily blocking nerve signals and relaxing muscles. Although Botox is most famously approved for cosmetic uses, it is also approved in the United States for a number of medical conditions, including muscle spasms, eye disorders, and migraines.

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The FDA's warning letters were primarily sent to cosmetics websites. In both cases, the FDA said the companies offered unofficial or mislabeled Botox-like drugs that were not FDA-approved. In addition to the original drug introduced by Allergan in 1989, the FDA has approved several competing versions.

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FDA-approved Botox drugs carry the FDA's most serious warnings, a boxed label that alerts doctors and patients that the drug can cause serious or life-threatening side effects.

In rare cases, the toxin can spread beyond the injection site to other parts of the body, paralyzing or weakening the muscles needed for breathing and swallowing. Signs of botulism include difficulty swallowing or breathing, slurred speech, and muscle weakness. These symptoms may occur several hours after the injection.

The FDA said in a press release Wednesday that patients should only receive the drug from a health care professional who is qualified and trained to administer the drug. Patients with signs of botulism should “seek immediate medical care,” the agency noted.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education and the Robert Wood Johnson Foundation. AP is solely responsible for all content.