In 2021, police officers arrested a woman after she offered undercover agents counterfeit Botox injections in a makeshift medical office she had set up in a Los Angeles hotel room. A year later, a California-based doctor pleaded guilty to hiding from patients that the drugs she had injected them with were not name-brand Botox, but unapproved versions she bought online.
Now, federal and state health officials are investigating a spate of illnesses linked to counterfeit or improperly administered Botox that has sickened 22 people across 11 states.
“It’s like Groundhog Day,” said Timothy Mackey, a professor at the University of California, San Diego, who studies counterfeit medications. Since 2012, federal agencies have sent more than 2,000 warning letters to doctors or medical centers that purchased counterfeit or unapproved Botox for use in injections. Experts said there were two key factors fueling the problem: Consumers often don’t know to check that what they are getting is real, and fake products are readily available.
“Our supply chain has been infiltrated with counterfeit Botox — historically, presently, and will be in the future,” said George Karavetsos, a former director of the Food and Drug Administration’s Office of Criminal Investigations.
Brand-name cosmetic Botox, which is used for reducing wrinkles and signs of aging, contains small amounts of botulinum toxin that aren’t harmful when delivered in the right dose. But unapproved products may contain incorrect or even dangerously high doses, unpurified versions of these toxins or possibly none of the drug at all, Mr. Karavetsos said. “It could be anything from saline solution to tap water to a super potent concentration of botulinum toxin A, which could kill you,” he said.
An internet search found several websites selling products that matched the F.D.A.’s description of counterfeit Botox linked to the illnesses currently being investigated. Dr. David Shafer, a plastic surgeon in New York City, said that while he only purchases Botox directly from the manufacturer, he regularly receives emails advertising unauthorized or off-brand versions from abroad. One such message advertised “Korean-made” Botox — “We are ready to offer the best price,” the email read, with a WhatsApp number to contact the seller.
“If you go online and you Google and somebody says they have Botox, most of the time, that’s not going to be a legitimate source,” said Sam Louis, a lawyer who has prosecuted cases related to counterfeit Botox at the Justice Department.
Experts also warned that some people who provide injections may not be properly trained deliver them. In the current string of cases, the injured patients had either received injections from “unlicensed or untrained individuals,” or gotten the shots in nonmedical settings, like homes or spas, the Centers for Disease Control and Prevention has said. In King County, Wash., three people sought medical care after receiving botulinum toxin injections at the same cosmetic spa, a spokesperson for the local health department told The Times.
People who haven’t gotten Botox before may be particularly susceptible to counterfeit Botox if they’re looking for a discounted price, said Dr. Ladan Shahabi, director of cosmetic dermatology at UCLA Health in Santa Monica. They may seek out injections advertised on Groupon, or try to get care at facilities that are not properly accredited.
“Just because you walk into a treatment room and someone has a white coat on does not mean that they are a physician,” said Dr. Seth L. Matarasso, a cosmetic dermatologist and the president of the American Society for Dermatologic Surgery. But even properly credentialed doctors have been found injecting counterfeit Botox in the past.
Many consumers consider the injections a cosmetic procedure, not a medical one, and simply trust that they’re getting the real product, Dr. Mackey said. “Most patients are never going to see the box, the vial, anything,” he said.
How consumers can stay safe
The F.D.A. has released images of counterfeit packaging, warning people to avoid a certain lot number, as well as boxes that say they contain 150 units. The F.D.A. has said authentic Botox does not come in that unit.
Dr. Andrea Best, vice president of safety and clinical sciences for aesthetics and devices at AbbVie, which manufactures authorized Botox, said the company was working with regulatory and law enforcement agencies to investigate counterfeit products. She recommended that people ask providers to see the product and packaging before they get an injection, looking to ensure it has a tamper-evident seal.
But counterfeit products can sometimes be sophisticated and hard to spot even when you look at the packaging, Mr. Karavetsos said, which is one reason it’s essential to see a properly credentialed and trained provider.
Health officials in New York City, where three people fell ill after receiving injections from nonmedical providers, warned against getting Botox from beauticians or aestheticians. Dr. Shahabi recommended seeking out a medical facility and licensed provider — such as a board-certified dermatologist — who has expertise in cosmetic treatments.
“Consumers have to be the first point of surveillance for themselves,” Dr. Mackey said.
Source link: https://www.nytimes.com/2024/04/25/well/live/counterfeit-botox-risks.html