FDA Issues Alert on Counterfeit Botulinum Toxin
On 16 March 2024 the US Food and Drug Administration (FDA) issued an alert to health care professionals and consumers regarding the discovery of counterfeit botulinum toxin products.
- These counterfeit products have been administered for cosmetic purposes, leading to adverse events, including hospitalizations.
- Patients who received the counterfeit botulinum toxin reported symptoms such as blurred or double vision, difficulty swallowing, dry mouth, constipation, incontinence, shortness of breath, weakness, and difficulty lifting their head.
- Both licensed and unlicensed individuals have administered these counterfeit products in non-medical or unlicensed settings.
- Counterfeit products are typically purchased from unlicensed sources, posing significant risks due to potential misbranding, adulteration, contamination, improper storage, and overall ineffectiveness.
- Only qualified medical doctors and dentists may inject neurotoxin in South Africa. AAMSSA registered aesthetic doctors use legally licensed SAHPRA registered botulinum toxin, administered in a medical setting
For more information on how to recognise counterfeit botulinum toxin go to the FDA website. Click to read more: https://www.fda.gov/drugs/drug-safety-and-availability/counterfeit-version-botox-found-multiple-states