Seven women have fallen ill after receiving counterfeit botulinum neurotoxin (BoNT) injections, commonly known as Botox. The incidents, which occurred in February and March 2024, have prompted a multistate investigation involving the Food and Drug Administration (FDA), CDC, and health departments in New York City and Tennessee.
The affected women, aged 26 to 55, experienced a range of symptoms including drooping eyelids, dry mouth, difficulty swallowing, shortness of breath, and weakness. These symptoms appeared within days of receiving the injections, which were administered in non-medical settings by unlicensed individuals. Four of the seven patients required hospitalization, with two needing intensive care unit monitoring.
Last month, Food Poisoning News reported on a similar case in Hong Kong where a 57 year-old woman fell critically ill with suspected botulism after receiving Botox injections from an unlicensed beauty parlor in neighboring mainland China.
Investigations revealed that the Tennessee and Kentucky patients received injections from a relative of one recipient who was not licensed to administer such treatments. The FDA confirmed that the product used in these cases was counterfeit. The New York City patients, while unrelated to the Tennessee cases, also received injections in non-medical settings, likely from unlicensed practitioners. In one instance, the patient reported paying less than the standard wholesale price for the treatment, while another mentioned the product was purchased overseas.
These incidents highlight the dangers of seeking cosmetic treatments from unlicensed providers or in non-clinical settings. While FDA-approved BoNT products are generally considered safe when administered by trained professionals, the use of counterfeit products or improper administration techniques can lead to severe health consequences.
The investigation has not definitively determined the cause of these illnesses, but possible factors include the use of more potent counterfeit products, the presence of harmful additives, or increased susceptibility to BoNT effects in some individuals.
In light of these events, the FDA is urging the public to exercise caution when seeking cosmetic treatments. BoNT injections should only be administered by licensed and trained providers using FDA-approved products in appropriate clinical settings. Consumers are advised to verify the credentials of their providers and the authenticity of the products used.
Healthcare providers are being asked to remain alert and inquire about recent BoNT injections when patients present with symptoms resembling botulism. Prompt reporting to local health departments is crucial if botulism is suspected.
Commenting on this story, one national food safety attorney said, “There are potentially serious risks associated with unregulated cosmetic procedures. It is highly important that consumers prioritize safety over cost or convenience when it comes to medical treatments. A quick review of any medical professional’s medical record can well save the dignity and even the lives of those seeking medical intervention, even cosmetic medical intervention.”
