The CDC and FDA are investigating reports of patients in nearly a dozen US states who were injected with counterfeit Botox.
Alliance Jens Kalaene/image via Getty Images
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Alliance Jens Kalaene/image via Getty Images
The CDC and FDA are investigating reports of patients in nearly a dozen US states who were injected with counterfeit Botox.
Alliance Jens Kalaene/image via Getty Images
Attention, Botox users: Public health authorities are warning that counterfeit versions of the injection are circulating — and have already sickened patients — in several U.S. states.
Nineteen people have reported adverse reactions to botulinum toxin injections since last Friday, including nine who were hospitalized. Centers for Disease Control and Prevention he said in a statement. They are located in nine states: Colorado, Florida, IllinoisKentucky, Nebraska, New Jersey, New York, Tennessee and Washington.
All affected patients are identified as female and range in age from 25 to 59 years. All but one reported receiving the injections for cosmetic purposes. And all were treated either by untrained people, or in non-healthcare settings such as homes and spas.
“These incidents have occurred when counterfeit Botox is injected by licensed and unlicensed individuals and/or in non-medical or unlicensed settings,” the US Food and Drug Administration he said in a warning to healthcare professionals and consumers.
Symptoms included blurred or double vision, difficulty swallowing, dry mouth, constipation, incontinence, shortness of breath, weakness and difficulty lifting one’s head after the injection — which the FDA said are similar to those seen in botulism. a rare and potentially fatal diseaseit attacks the body’s nervous system.
Four people nationwide were treated for botulism because of concerns that the toxin had spread beyond the injection site, the CDC said. Five people were tested for the disease, all with negative results.
The CDC, FDA, and many state and local health agencies 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 “incorrect, adulterated, counterfeit, contaminated, improperly stored and transported, ineffective and/or unsafe.”
The FDA says there is currently no evidence that these incidents are linked to the brand of Botox made by pharmaceutical company AbbVie (which is one of several FDA approved brands neurotoxin, 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 caution anyone considering Botox to make sure they’re getting the real thing — which, experts tell NPR, starts with finding a reputable provider.
Dr. Seemal Desai, president of the American Academy of Dermatology, told NPR via Zoom that the rise in fake injectables underscores the urgent need for patients to understand who they’re choosing to get Botox, just like any other medical procedure.
“There are 19 too many patients who had an adverse event,” he said. “I hope what comes out of this is an opportunity to educate the public to be your own advocate, to help yourself avoid these issues by making the simple call to the right person.”
Choose a provider with the right qualifications
Botox injections should only be done in an office setting by a board-certified dermatologist or other appropriately trained clinician under the supervision of one, says Desai.
He says that’s because they have the requisite 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, in accordance with FDA guidelines, they purchase the product from the manufacturer itself, greatly reducing the risk of counterfeiting.
“Don’t just pick your person from a TikTok video or a Groupon or something you just Googled once and someone is the top search,” Desai adds. “Do a little more research.”
But that doesn’t mean it has to last long: The American Academy of Dermatology recommends using it online search tool to find a board certified dermatologist in your zip code.
There are other ways to check your provider, whether they are a dermatologist or not.
Anyone injecting a patient must be licensed in the state where they are performing the procedure, says Dr. Gregory Greco, the past president of the American Society of Plastic Surgeons.
And he says patients in most states can and should do some searching — whether through the health department, consumer affairs department or licensing boards — to find that license. In addition, he says, most drug manufacturers that sell to licensed health care providers will have those names listed on their website, so patients can cross-check there as well.
Certified providers put patient safety first, from how they sterilize injection equipment to avoid cross-contamination, Greco told NPR.
“When things go into your body, you have a responsibility to yourself and your safety to make sure you go to a qualified person,” he added.
Pay attention to the product
Greco says patients can also ask their doctors to show them their cabinets and refrigerators where the product is kept.
This could be particularly useful in the case of fake Botox, which the FDA says also involves counterfeiting the outer box and vial. It says one or more of the following will mark a horse (and asks consumers to report suspected counterfeits):
- Lot number is C3709C3
- The outer carton lists the active ingredient as “Botulinum Toxin Type A” instead of “OnabotulinumtoxinA”
- The outer box contains a language other than English
- The outer carton and vial 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 providers trying to cut costs by moving them through untrustworthy third parties – and harming their unsuspecting clientele.
The exact cost of the procedure is somewhat variable, though Greco says patients should be suspicious of any provider whose price generally seems too good to be true.
The FDA says the fake Botox has gifts on the vial 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 the fake Botox has gifts on the vial and packaging, including this label for 150 units.
US Food and Drug Administration
“I think the public needs to know that in no way, shape or form should patient safety be compromised,” Greco adds.
He hopes the investigation will not only identify the source and content of the copycats, but also discipline the bad actors who cut back – and warn others who might otherwise follow suit.
“Patients get hurt because [someone] he took a shortcut to get a product that was not genuine product and that is not fair to patients,” he said. “Patients didn’t know.”
Recognize the common – and unusual – side effects
Even bona fide Botox carries the risk of some side effects, though Greco stresses that it has a well-established safety profile.
Typical side effects include redness, swelling, tenderness or bruising at the injection site, and occasionally a droopy eyelid. He says other reactions, such as difficulty swallowing or speaking, have been reported but are extremely rare.
When it comes to the fakes, Greco says the reported side effects are much more serious.
Specifically, the patients’ inability to lift their heads afterward suggests that they were injected with a highly concentrated form of Botox that spread through the bloodstream, causing systemic symptoms.
Greco suspects the reaction occurred within 24 to 48 hours after the injection, though he says patients who had Botox longer than that can always call their doctor if they’re concerned.
The FDA says that anyone experiencing these specific symptoms should contact a healthcare professional or go to the emergency room and report the incident online.
Experts recommend taking all these precautions before your next appointment, even if it’s already scheduled — and postponing it if you have any concerns.
“If in doubt, do not inject,” the CDC says.
