The following summary is from a CDC Health Advisory issued on April 23, 2024:
The Centers for Disease Control and Prevention (CDC) is issuing this Health Alert Network (HAN) Health Advisory to alert clinicians about risks of counterfeit or mishandled botulinum toxin injections.
CDC, the U.S. Food and Drug Administration (FDA), and state and local partners are investigating clusters of 22 people in 11 U.S. states reporting adverse effects after receiving injections with counterfeit botulinum toxin or injections administered by unlicensed or untrained individuals or in non-healthcare settings, such as homes or spas. Eleven patients were hospitalized and none have died.
When botulinum toxin diffuses around the injection site, it can result in adverse effects. Botulism is the disease caused by botulinum toxin circulating in the blood and producing effects remotely from the injection site. There may be symptom overlap between the presentation of localized adverse effects from injection of botulinum toxin, especially in the head and neck, and the early symptoms of botulism. Information about the botulinum toxin injection (e.g., dose) can help distinguish between botulism and localized adverse effects but is challenging to obtain for counterfeit products.
Clinicians and health departments should consider the possibility of adverse effects from botulinum toxin injections in patients presenting with localized paralysis. Clinicians should immediately contact their state, tribal, local, or territorial health department if they suspect botulism.