The FDA issued warning letters to a number of websites that were selling counterfeit or unapproved versions of Botox or other injectable treatments. Antonio_Diaz/iStockphoto/Getty Images
As mentioned by CNN
American health regulators on Wednesday sent warning letters to 18 websites that sold counterfeit or unapproved versions of botulinum toxin and similar injectable products commonly used to smooth wrinkles.
The FDA said it was taking action after receiving reports of injuries linked to these products, including toxic side effects.
Botulinum toxin is a diluted, purified form of the toxin that ranks among the most poisonous substances in the world. The component works by temporarily blocking nerve signals and relaxing muscles. Although it is most commonly used as a cosmetic treatment, in the United States the product is also approved for a range of medical conditions, including muscle spasms, vision problems, and migraines.
The warning letters are mostly addressed to cosmetic websites. In each document, the agency stressed that companies offer unofficial or misbranded versions of products similar to Botox that have not been approved by the agency. The original product introduced by Allergan in 1989 has FDA-approved versions.
FDA-approved Botox products carry the agency’s most serious warning – a separate warning on the labeling for physicians and patients that alerts to possible 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 muscles needed for breathing and swallowing. Signs of botulism include difficulty swallowing or breathing, slurred speech, and muscle weakness; these symptoms can appear several hours after the injection. In a press release, the FDA stated that patients should receive products only from licensed healthcare professionals with appropriate training. Patients showing signs of botulism should seek medical attention immediately.
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