Warning: Dangerous counterfeit versions of botulinum toxin — commonly known as Botox — have been identified in connection with an outbreak that has affected 19 individuals across nine states. This has resulted in nine hospitalizations, according to federal safety officials.
An alert issued on Tuesday by the U.S. Food and Drug Administration cautions consumers and healthcare providers about the presence of unsafe counterfeit Botox products in multiple states. These counterfeit products have been administered to individuals for cosmetic purposes.
The FDA has warned that these products "appear to have been purchased from unlicensed sources" and may be misbranded, adulterated, counterfeit, contaminated, improperly stored and transported, ineffective, and/or unsafe.
Following the administration of potentially fake products, two states — Illinois and Tennessee — reported cases involving symptoms similar to botulism last week. Subsequently, an additional 13 cases have been reported in nine more states. All cases involve women who received injections of counterfeit Botox from both licensed and unlicensed individuals in non-medical settings such as homes or spas, as reported by the Centers for Disease Control and Prevention.
The FDA is collaborating with Botox manufacturer AbbVie to detect, investigate, and eliminate suspected counterfeit Botox products discovered in the U.S. At present, there is no evidence to suggest that the illnesses are related to the company's FDA-approved Botox, as the authentic product is deemed safe and effective for its intended purposes, according to the FDA.
"In partnership with public health authorities, we have verified the security of our Botox and Botox cosmetic supply chain, as well as the safety, quality, and effectiveness of all products we produce and distribute," AbbVie subsidiary Allergan informed CBS MoneyWatch on Friday.
Tips to steer clear of counterfeit Botox
If you are contemplating Botox for medical or cosmetic purposes, the CDC recommends inquiring whether the provider, clinic, or spa is licensed and trained to administer the injections, and if the product is FDA approved and obtained from a reputable source. The agency also mentioned that some states offer a look-up tool to verify licensing.
Individuals who are uncertain should refrain from receiving the injection, and those who exhibit symptoms of botulism should promptly seek medical attention or visit an emergency room, as per the CDC's guidance.
Having been approved for cosmetic use more than two decades ago, Botox has become a widely sought-after drug for smoothing wrinkles and achieving a more youthful appearance. The average cost of Botox injections is around $530, as reported by the American Society of Plastic Surgeons. The effects of a single shot typically last three to four months, necessitating additional injections to maintain a wrinkle-free look.
In a bid to crack down on unregulated Botox and other cosmetic treatments, federal officials have taken action in the past. In 2023, officers from the U.S. Customs and Border Protection in Ohio intercepted shipments of such fillers originating from Bulgaria, China, Korea, and Spain.
