Fake Botox is poisoning people and landing them in the hospital

By Elizabeth Pratt | Fact-checked by Davi Sherman
Published April 17, 2024

Key Takeaways

  • There have been 19 reports of harmful reactions to botulinum toxin injections across nine states. 

  • The Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), and local and state health departments are investigating and say that the reactions occurred after people were given counterfeit or mishandled botox by unlicensed professionals or in a non-healthcare setting.  

The Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), and local and state health departments are investigating reports of 19 people across nine states experiencing harmful reactions to botulinum toxin injections.

The CDC says that those experiencing botulism-like illness received injections of counterfeit or mishandled botulinum toxin from unlicensed or untrained individuals or in non-healthcare settings.[] 

“Public health and regulatory officials have found that some people received injections with counterfeit products or products with unverified sources. Investigation into the sources of these products is ongoing,” the agency said in a statement released earlier this week.[] 

Nine of the people experiencing harmful reactions were hospitalized, and four were treated with botulism antitoxin due to concerns that the botulinum toxin had spread beyond the injection site.[]

So far, reactions have been reported in Colorado, Florida, Illinois, Kentucky, Nebraska, New Jersey, New York, Tennessee and Washington.[]

All of those who experienced reactions identified as females and were aged between the ages of 25 and 59. Eighteen of the 19 individuals stated that they had received botox injections for cosmetic reasons.[] 

Zakia Rahman, MD, Clinical Professor of Dermatology at Stanford University, says the situation is worrying. “It is really concerning. Particularly as we treat aesthetic patients, we want to make sure that their health is number one, because they're not necessarily coming in to see us—at least for aesthetics—for any medical indication. And I think for us, as physicians, ‘do no harm’ is really part of the Hippocratic Oath, so it is concerning when people fall ill for something that they shouldn't,” she tells MDLinx.

Botulinum toxin is one of the most dangerous substances on earth. When given at the correct dose by a licensed healthcare professional, it is considered safe, but in the wrong hands, it can lead to serious complications.[][] 

“When receiving Botox injections from a licensed healthcare professional, Botox is widely viewed as low-risk, with serious side effects being rare. Complications arise when counterfeit or non-regulated preparations are used instead of Botox. As these compounds are not regulated under strict guidance by regulatory bodies, the dose and components of the injection can vary, leading to the risk of serious side effects, such as systemic symptoms of botulism or other toxicity,”  Joseph Zahn, MD, Clinical Assistant Professor of Dermatology at George Washington University, tells MDLinx.

Agency response

Both the CDC and FDA are urging healthcare providers to be alert to symptoms of botulism. These symptoms may include difficulty swallowing, blurred or double vision, shortness of breath, dry mouth, incontinence, constipation, weakness, and difficulty lifting one’s head.[] 

The CDC advises physicians who suspect systemic botulism to immediately call the health department in their state for a consultation and the release of antitoxin. In the event that the state health department does not answer, the CDC advises that healthcare providers contact the 24-hour CDC clinical botulism service at 770-488-7100.[]

The FDA is investigating reports of counterfeit Botox linked to harmful reactions across nine states. The agency advises that genuine FDA-approved AbbVie or Allergan Aesthetics Botox should be considered safe and effective.[] 

Under federal law, all healthcare providers who dispense or administer prescription drugs must purchase them from an authorized source. Counterfeit Botox products currently circulating have signs of counterfeiting on the outer carton as well as the vial, and can be identified by lot number C3709C3. The active ingredient listed on the counterfeit carton is “Botulinum Toxin Type A” instead of “OnabotulinumtoxinA.” The carton may also contain language other than English. Additionally, the carton and vial may indicate that the product comes in 150-unit doses, a unit not made by AbbVie or Allergan. This dosage is not made by either AbbVie or Allergan.[] 

“Healthcare professionals should always obtain properly regulated Botox through official channels and suppliers, such as state-licensed pharmacies. The FDA, for instance, suggests that healthcare providers be cautious if the drug or packaging appears different from what they normally receive, if new side effects of the medication are noted, or if the medication was bought from an online pharmacy,” Dr. Zahn says. 

“It’s difficult to know exactly why this number of cases may be occurring all at the same time. It may be possible that these patients were treated with a similarly contaminated or improperly manufactured Botox-like compound, but it may also be possible that multiple different counterfeits may exist that give similar symptoms,” he adds.

As of April 12, 19 reports had been made across nine states. But Dr. Rahman says it is possible that more cases could be reported. “The challenging thing is that, particularly when we use these products, [the] maximum effect can often happen up to two weeks after injection. So I'm a little worried, and I really hope that there's not more people who end up getting reported,” she says.

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