In several cases, patients received injections with “counterfeit products or products with unverified sources,” the CDC said.
The affected patients, all women ranging from their mid-20s to late 50s, had in all but one case received Botox for cosmetic purposes, the CDC said. The women reported symptoms such as blurred vision, difficulty swallowing, drooping eyelids and muscle weakness; the CDC said the symptoms were consistent with botulism, a rare but serious (and most commonly food-borne) illness that attacks the body’s nervous system.
Botulinum toxin, most commonly known by the brand-name Botox, is a purified form of the neurotoxin that was first approved by the FDA in the 1980s. Used cosmetically to temporarily smooth lines and wrinkles, lift drooping brows or soften square jaw lines, Botox can also be used to treat conditions such as excessive sweating, known as hyperhidrosis, or to correct a “lazy eye.”
Seemal R. Desai, president of the American Academy of Dermatology, said Botox procedures — or similar brand-name treatments such as Dysport, Xeomin and Jeuveau — are generally considered safe when done by a board-certified dermatologist using regulated products.
From a public health perspective, Desai said it was important that people considering Botox are aware of black-market products — and the equally shady marketplace of unlicensed practitioners.
“Counterfeit injectables are happening, they’re out there, and they’re being administered by non-board certified dermatologists who don’t have training,” Desai said.
The roughly $9.5 billion market for Botox has surged over the years, particularly during and after the coronavirus pandemic because of pent-up demand and a swath of the population spending much of the workday on Zooms and video chats. The number of Botox procedures in 2022 jumped 74 percent in a two-year period to more than 8.7 million, according to data from the American Society of Plastic Surgeons.
Botox injections are considered minimally invasive compared to cosmetic procedures such as blepharoplasty and rhinoplasty (eyelid surgery and nose jobs) but licensing requirements vary widely by state.
In Illinois, where two patients were hospitalized, cosmetologists and aestheticians are prohibited from administering Botox injections. The Illinois patients each received injections from a licensed nurse who was “performing work outside her authority,” the Illinois Department of Public Health said in a statement.
In Tennessee, where four patients fell ill and two were hospitalized, state health officials said “ongoing investigation suggests that the product administered was counterfeit.”
“State regulations vary so much, not only in terms of who can administer aesthetic injections that involve a needle, but also how things like medical spas and cosmetic spas are classified and regulated,” Desai said.
The CDC said the adverse reactions from Botox injections have come from Colorado, Florida, Illinois, Kentucky, Nebraska, New Jersey, New York, Tennessee and Washington state.
Price, Desai added, is not always the indicator of quality or safety in a field where the adage “you get what you pay for” usually turns out to be true.
“I have seen medical spas that have non-physicians injecting these products that actually charge more than a board-certified dermatologist,” Desai said.
Depending on state regulations, practitioners such as a nurse injector or aesthetician can take courses in as little as a weekend to achieve some level of certification — “But they’re not trained in human anatomy or adverse effects, or blindness, or stroke, or infection,” Desai cautioned.
“People think, ‘Oh, if I can easily learn to do this, I can [give Botox injections] too,’” he said. The best way to avoid concerns about getting counterfeit products is to visit a board-certified dermatologist, he said. “Those individuals have the longest track record of safety.”