CDC and FDA Investigate Harmful Reactions from Counterfeit Botox Injections

The Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) are investigating reports of adverse reactions and hospitalizations linked to counterfeit Botox products administered across multiple U.S. states. At least 19 women in 9 states have reported experiencing botulism-like symptoms, including weakness, blurry vision, difficulty breathing and swallowing, and dry mouth, after receiving Botox injections from unlicensed or untrained individuals or in non-healthcare settings.

The affected individuals, ranging in age from 25 to 59, received the injections for cosmetic purposes in various settings, including homes and spas. Nine of the women were hospitalized, and four were treated with a botulism antitoxin. The CDC, FDA, and local health departments are working to investigate the issue and remove any counterfeit Botox products from the market.

Why this matters: The use of counterfeit or mishandled Botox products by unlicensed providers poses serious health risks to consumers. This investigation highlights the importance of seeking cosmetic treatments only from qualified medical professionals using FDA-approved products.

The FDA warned that medications purchased from unlicensed sources may be misbranded, adulterated, counterfeit, contaminated, improperly stored and transported, ineffective, and/or unsafe. No adverse reactions have been linked to the FDA-approved Botox product from AbbVie. The CDC advises anyone considering botulinum toxin injections to ensure the provider is licensed and trained, and that the product is FDA-approved and obtained from a reliable source.

Botox is a neurotoxic protein that blocks nerve signals causing muscle contraction, and is approved for certain medical and cosmetic treatments when administered by licensed healthcare providers. However, improper preparation, storage, or administration can lead to botulism, a rare but serious illness. The CDC warns that lack of proper treatment could lead to paralysis, respiratory failure, or death.

The investigation into the sources of these counterfeit products is ongoing, spanning multiple states including Colorado, Florida, Illinois, Kentucky, Nebraska, New Jersey, New York, Tennessee, and Washington. The CDC has reported no deaths related to these incidents and advises consumers to seek immediate medical care if experiencing botulism symptoms after a Botox injection.

Key Takeaways

• CDC and FDA investigating adverse reactions to counterfeit Botox in 9 states.
• 19 women hospitalized with botulism-like symptoms after receiving Botox from unlicensed providers.
• Counterfeit Botox poses serious health risks, including paralysis, respiratory failure, and death.
• Consumers should only receive Botox from licensed healthcare providers using FDA-approved products.
• Investigation into the source of counterfeit Botox is ongoing across multiple states.