Beware, Botox users: Public health authorities are warning that counterfeit versions of the injectable are circulating — and have already made patients sick — in several U.S. states.
Nineteen people reported harmful reactions to botulinum toxin injections as of last Friday, including nine who were hospitalized, the Centers for Disease Control and Prevention said in a release. They are located in nine states: Colorado, Florida, Illinois, Kentucky, Nebraska, New Jersey, New York, Tennessee and Washington.
All of the affected patients identify as female, and range in age from 25 to 59. All but one reported receiving the injections for cosmetic purposes. And they were all treated either by untrained individuals, or in non-health care settings like 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 U.S. Food and Drug Administration said in a warning to health care 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 injection — which the FDA says are similar to those seen when botulism, a rare and potentially fatal illness, attacks the body's nervous system.
Four people nationwide were treated for botulism out of concerns that the toxin had spread beyond the injection site, the CDC said. Five people were tested for the illness, 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 unsafe."
The FDA says there is currently no indication that these incidents were linked to the brand-name Botox manufactured by the pharmaceutical company AbbVie (which is one of several FDA-approved brands of the 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 are warning anyone who is considering Botox to make sure they're getting the real thing — which, experts tell NPR, starts with finding a trustworthy provider.
Dr. Seemal Desai, the president of the American Academy of Dermatology, told NPR over Zoom that the rise in counterfeit injectables underscores the urgent need for patients to understand who they're choosing to perform Botox, like any other medical procedure.
"There are 19 patients too many who have had an adverse event," he said. "I hope what comes out of this is the opportunity to educate the public on being your own advocate, to kind of help yourself avoid these issues by making the simple call to the right person."
Pick a provider with the right qualifications
Botox injections should only be performed in a medical office by a board-certified dermatologist, or other appropriately trained clinician under the supervision of one, Desai says.
He says that's because they have the requisite years of training to avoid certain risks — like knowing, for example, where the forehead artery is located — and treat potential complications if they arise. And, in compliance with FDA guidelines, they purchase the product from the manufacturer itself, significantly reducing the risk of counterfeits.
"Don't just pick your person off a TikTok video or from a Groupon or from something that you just searched on Google once and someone's the top search," Desai adds. "Do a little bit more research."
But that doesn't mean it has to take long: He recommends using the American Academy of Dermatology's online search tool to find a board-certified dermatologist within your zip code.
There are other ways to vet your provider, whether or not they're a dermatologist.
Anyone who is injecting a patient has to be licensed in the state where they perform 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 a little searching — whether through the health department, consumer affairs department or licensing boards — to find that license. Plus, he says, most drug manufacturers that sell to licensed health care providers will have those names listed on their website, so patients can cross-reference there too.
Reputable providers put patient safety first, from the way they sterilize equipment to administer the injection to avoid cross-contamination, Greco told NPR.
"When things are being put into your body, you have a responsibility to yourself and your own safety to make sure that you're going to a qualified individual," 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.
That could be especially useful in the case of fake Botox, which the FDA says also include counterfeiting of the outer carton and vial. It says one or more of the following will signal a knockoff (and asks consumers to report suspected counterfeits):
- The lot number is C3709C3
- The outer carton displays the active ingredient as "Botulinum Toxin Type A" instead of "OnabotulinumtoxinA"
- The outer carton contains language other than English
- The outer carton and vial are labeled as 150-unit doses (which is not a unit that AbbVie makes)
Even though the investigation is still underway, Greco believes the counterfeit products are the result of unlicensed providers trying to cut down on costs by getting them through unreliable third parties — and hurting their unknowing 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.
"I think the public has to be aware that in no way, shape or form should economics compromise patient safety," Greco adds.
He hopes the investigation will not only identify the source and contents of the counterfeits, but also discipline the bad actors who are cutting corners — and warn others who might otherwise follow suit.
"Patients are hurt because [someone] took a shortcut to get a product that was not authentic product, and that's not fair to the patients," he said. "The patients were unaware."
Recognize common — and unusual — side effects
Even bona fide Botox carries the risk of certain side effects, though Greco stresses it has a well-established safety profile.
Standard side effects include redness, swelling, tenderness or bruising at the injection site, and occasionally a droopy eyelid. He says other reactions, like difficulty swallowing or speaking, have been reported but are extremely rare.
When it comes to the counterfeits, Greco says the reported side effects are much more serious.
In particular, affected patients' inability to lift their heads afterward suggests to him that they were injected with a highly concentrated form of Botox that spread through the bloodstream, causing systemic symptoms.
Greco suspects that the reaction occurred within 24 to 48 hours after the injection, though he says patients who got Botox longer ago than that can always call their doctor if they're concerned.
The FDA says anyone experiencing those specific symptoms should contact a health care professional or go to the emergency room, and report the incident online.
Experts recommend taking all of these precautions ahead of your next appointment, even if it's already scheduled — and postponing it if you have any concerns.
"If in doubt, don't get the injection," the CDC says.
Copyright 2024 NPR. To see more, visit https://www.npr.org.