The CDC and FDA are investigating reports that patients in nearly a dozen U.S. states were injected with counterfeit Botox.
Jens Kalaene/photo alliance via Getty Images
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Jens Kalaene/photo alliance via Getty Images
The CDC and FDA are investigating reports that patients in nearly a dozen U.S. states were injected with counterfeit Botox.
Jens Kalaene/photo alliance via Getty Images
Attention, Botox users: Public health authorities are warning that counterfeit versions of the injectable are circulating – and have already sickened patients – in several US states.
Nineteen people reported harmful reactions to botulinum toxin injections last Friday, nine of whom were hospitalized, the Centers for Disease Control and Prevention said in a statement. They are located in nine states: Colorado, Florida, Illinois, Kentucky, Nebraska, New Jersey, New York, Tennessee and Washington.
All affected patients identify as female and range in age from 25 to 59 years old. All but one reported receiving injections for cosmetic purposes. And they were all treated either by untrained people or in non-health care settings, like homes or spas.
“These incidents have occurred when counterfeit Botox is injected by licensed or unlicensed individuals and/or in non-medical or unlicensed settings,” the U.S. Food and Drug Administration said in a warning to healthcare professionals. health and consumers.
Symptoms included blurred or double vision, difficulty swallowing, dry mouth, constipation, incontinence, shortness of breath, weakness and difficulty raising the head after the injection – which the FDA says are similar to those observed during attacks of botulism, a rare and potentially fatal disease. the nervous system of the body.
Four people nationwide were treated for botulism amid concerns that the toxin may have spread beyond the injection site, the CDC said. Five people have been tested for the disease, all with negative results.
The CDC, FDA and several state and local health departments are working to identify the sources of the counterfeits. The FDA said they appear to have been purchased from unlicensed sources, meaning they may be “misbranded, adulterated, counterfeit, contaminated, improperly stored and transported, ineffective and/or dangerous.”
The FDA says there is currently no indication that these incidents were related to the brand name Botox manufactured by the pharmaceutical company AbbVie (which is one of several neurotoxin brands approved by the FDA, including Dysport, Xeomin, Jeuveau and Daxxify).
“The genuine product should be considered safe and effective for its intended and approved uses,” the FDA added.
But public health officials are warning anyone considering Botox to make sure they get the real product — which, experts tell NPR, starts with finding a reputable provider.
Dr. Seemal Desai, president of the American Academy of Dermatology, told NPR over Zoom that the rise in counterfeit injectables highlights the urgent need for patients to understand who they choose to perform Botox, like any other medical procedure.
“There are 19 too many patients who have had an adverse event,” he said. “I hope what comes out of this is an opportunity to educate the public about being their own advocate, to kind of help themselves avoid these problems by just calling the right person.”
Choose a provider with the right qualifications
Botox injections should only be performed in a doctor’s office by a board-certified dermatologist or other trained clinician under the supervision of one, Desai says.
He says that’s because they have the years of training to avoid certain risks — like knowing, for example, where the frontal artery is — and to treat potential complications if they arise. And, following FDA guidelines, they purchase the product from the manufacturer itself, significantly reducing the risk of counterfeiting.
“Don’t just pick your person from a TikTok video, or from a Groupon, or from something you just Googled once and someone comes up at the top of the search,” Desai adds. “Do a little more research.”
But that doesn’t mean it has to take time: He recommends using the American Academy of Dermatology’s online search tool to find a board-certified dermatologist in your zip code.
There are other ways to verify your provider, whether they are a dermatologist or not.
Anyone injecting a product into a patient must be licensed in the state where they perform the procedure, says Dr. Gregory Greco, past president of the American Society of Plastic Surgeons.
And he says patients in most states can and should do a little research — whether with the Department of Health, Department of Consumer Affairs or licensing boards — to find that license. Additionally, he says, most drug manufacturers that sell to licensed health care providers will have these names listed on their website, so patients can cross-reference them as well.
Reputable providers prioritize patient safety, from how they sterilize equipment needed to administer the shot to avoid cross-contamination, Greco told NPR.
“When things are put into your body, you have a responsibility to yourself and your own safety to make sure you go to a qualified person,” he added.
Pay attention to the product
Greco says patients can also ask their doctor to show them the cabinets and refrigerators where the product is stored.
This could be particularly useful in the case of fake Botox, which the FDA says also includes counterfeiting of the outer packaging and bottle. It states that one or more of the following will flag a counterfeit (and asks consumers to report suspected counterfeits):
- The lot number is C3709C3
- The outer packaging lists the active ingredient as “Botulinum Toxin Type A” instead of “OnabotulinumtoxinA.”
- The outer carton contains a language other than English
- The outer package and bottle are labeled as 150 unit doses (which is not a unit manufactured by AbbVie).
Although the investigation is still ongoing, Greco believes the counterfeit products are the result of unlicensed suppliers attempting to cut costs by passing them through unreliable third parties – and harming their unwitting customer base.
The exact cost of the procedure is somewhat variable, although Greco says patients should be wary of any provider whose price usually seems too good to be true.
The FDA says counterfeit Botox has giveaways on the bottle and packaging, including this label for 150 units.
US Food and Drug Administration
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US Food and Drug Administration
The FDA says counterfeit Botox has giveaways on the bottle and packaging, including this label for 150 units.
US Food and Drug Administration
“I think the public needs to be aware that, one way or another, the economy should not compromise patient safety,” adds Greco.
He hopes the investigation will not only identify the source and content of the counterfeits, but also discipline bad actors who take shortcuts – and warn those who might otherwise follow suit.
“Patients are hurt because (someone) took a shortcut to get a product that was not a genuine product, and that’s not fair to patients,” he said. “The patients didn’t know.”
Recognizing common – and unusual – side effects
Even genuine Botox carries a risk of certain side effects, although Greco points out that it has a well-established safety profile.
Standard side effects include redness, swelling, tenderness or bruising at the injection site and sometimes a drooping eyelid. He says other reactions, such as difficulty swallowing or speaking, have been reported but are extremely rare.
When it comes to counterfeits, Greco says the reported side effects are much more serious.
In particular, the inability of the affected patients to raise their heads afterwards suggests that they were injected with a highly concentrated form of Botox which spread into the bloodstream, causing systemic symptoms.
Greco suspects the reaction occurred within 24 to 48 hours of the injection, although he says patients who received Botox longer ago can still call their doctor if they are concerned.
The FDA says anyone experiencing these specific symptoms should contact a healthcare professional or go to an emergency room and report the incident online.
Experts recommend taking all these precautions before your next appointment, even if it’s already scheduled, and rescheduling if you have concerns.
“When in doubt, do not give yourself the injection,” the CDC says.
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