Dangerous counterfeit versions of botulinum toxin — better known as Botox — are linked to an outbreak that has sickened 19 people in nine states, prompting nine hospitalizations, federal safety officials warn.
On a Tuesday alarm to consumers and health care providers, the US Food and Drug Administration said that dangerous counterfeit versions of Botox were found in many states and administered to people for cosmetic purposes.
The products “appear to have been purchased from unlicensed sources” and may be incorrect, adulterated, counterfeit, contaminated, improperly stored and transported, ineffective and/or unsafe, the FDA said.
Two states — Illinois and Tennessee — reported last week half a dozen cases involving botulism-like symptoms below shots of potentially fake products. Since then, 13 more cases have been reported in an additional seven states, all involving women who received fake Botox from licensed and unlicensed individuals in non-medical settings such as homes or spas. to the Centers for Disease Control and Prevention.
People have reported experiencing symptoms of botulism, including blurred or double vision, droopy eyelids, difficulty swallowing, dry mouth, slurred speech, difficulty breathing, and fatigue. Cases were reported in Colorado, Florida, Illinois, Kentucky, Nebraska, New Jersey, New York, Tennessee and Washington.
US Food and Drug Administration
FDA is working with Botox maker AbbVie to identify, investigate and remove suspected counterfeit Botox products found in the U.S. Currently, there is nothing to indicate that illnesses are linked to the company’s FDA-approved Botox, with the original product is safe and effective for its approved uses, the FDA noted.
US Food and Drug Administration
“Working with public health authorities, we have confirmed the safety of the Botox and Botox cosmetics supply chain, as well as the safety, quality and efficacy of all the products we manufacture and distribute,” AbbVie subsidiary Allergan told CBS MoneyWatch the manufacture.
How to avoid fake botox
If you’re considering Botox for medical or cosmetic reasons, the CDC advises asking if the provider, clinic or spa is licensed and trained to give the injections and if the product is FDA-approved and purchased from a reputable source. Some states have a search tool that can be used to check licensing, according to the agency.
Those in doubt should not inject, and those experiencing symptoms of botulism should seek medical attention or go to an emergency room immediately, the CDC said.
Approved for cosmetic use more than 20 years ago, Botox is popular drug to smooth out wrinkles and look younger, with injections typically costing about $530, according to the American Society of Plastic Surgeons. The results of one shot last three to four months on average, so additional shots are needed to stay wrinkle-free.
Federal officials have previously cracked down on unregulated Botox and other cosmetic treatments. In 2023, US Customs and Border Protection officials in Ohio intercept such fillers which had been sent from Bulgaria, China, Korea and Spain.
