The US Food and Drug Administration is warning that dangerous counterfeit versions of Botox have been identified in multiple states, putting the safety of consumers at risk.
Some serious symptoms – including blurred vision, difficulty swallowing, shortness of breath, difficulty lifting one’s head and even hospitalizations – have been linked to the use of counterfeit Botox, the FDA said on Tuesday.
“These symptoms are similar to those seen when botulinum toxin spreads to other parts of the body,” according to the FDA announcement.
The agency announced that it is working closely with the US Centers for Disease Control and Prevention, state health departments and manufacturers to investigate and identify these counterfeit products and remove them from the market.
Botulinus, Clostridium botulinum, This bacterium secretes a toxin, Botox, which inhibits the neurons responsible for muscle contraction. Image produced using optical microscopy X 2000. (Photo by: BSIP/Universal Images Group via Getty Images) BSIP/Universal Images Group/Getty Images
As of Friday, a total of 19 women from nine states – Colorado, Florida, Illinois, Kentucky, Nebraska, New Jersey, New York, Tennessee, and Washington – reported “harmful reactions” after receiving Botox injections from unlicensed or untrained individuals or in places that were not health care settings, such as homes or spas, according to the CDC. The patients were between 25 and 59 years old.
Nine of the women were hospitalized and four were treated with botulism antitoxin medication due to concerns that the botulinum toxin could have spread beyond the injection site. Five women were tested for the illness botulism. Their results were negative.
The incidents of counterfeit Botox being administered to consumers appear to be connected to products that have been purchased from unlicensed sources and then administered by either unlicensed or licensed providers.
The FDA warns health care professionals that purchasing and administering counterfeit products puts patients’ health at risk and all providers should check products for any signs of counterfeiting before using them.
The counterfeit Botox products may be identified by the lot number C3709C3 found on the outer carton and vial, the FDA said.
The outer carton also may display the active ingredient as “Botulinum Toxin Type A” instead of “OnabotulinumtoxinA.” Also, the carton and vial may indicate 150-unit doses, which is not a unit made by the companies AbbVie or Allergan, the FDA said, and the outer carton may contain language that is not English.