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The US Food and Drug Administration has warned that fake versions of Botox are available in several states, putting the safety of users at risk.
Some serious symptoms — including blurred vision, difficulty swallowing, shortness of breath, trouble lifting the head and hospitalization — have been linked to fake Botox use, the FDA reported Tuesday.
“These symptoms are similar to what was observed. botulinum toxin It also spreads to other parts of the body,” he said. FDA notice.
The agency announced that it is working closely with the US Centers for Disease Control and Prevention, state health departments and manufacturers to investigate and identify these counterfeit products and remove them from the market.
As of Friday, a total of 19 women from nine states — Colorado, Florida, Illinois, Kentucky, Nebraska, New Jersey, New York, Tennessee and Washington — reported “adverse reactions” after receiving Botox injections from unlicensed or untrained individuals. Non-health care areas settings such as home or spa; According to the CDC. The patients are between 25 and 59 years old.
Nine of the women were hospitalized and four were treated with botulism antitoxin because of concerns that the botulinum toxin could spread beyond the injection site. Five women were diagnosed with botulism. Their results were negative.
Instances of counterfeit Botox being administered to consumers appear to be related to products purchased without a license and then administered by unlicensed or licensed providers.
The FDA warns healthcare professionals that purchasing and administering counterfeit products puts patients' health at risk, and that all providers should check for any signs of counterfeiting before using products.
Counterfeit Botox products can be identified by the lot number C3709C3 on the outer carton and vial, the FDA said.
The outer carton may list the active ingredient as “Botulinum Toxin Type A” instead of “OnabotulinumtoxinA”. Also, the carton and vale may indicate a 150-unit dose, which is not a unit made by the companies AbbVie or Allergan, the FDA said, and the outer carton may contain non-English language.
The proliferation of fake Botox has alarmed San Francisco-based board-certified dermatologist Dr. Lavanya Krishnan, who founded the practice. Aria Derm And he has been closely following FDA and CDC warnings.
“I think it's horrible and really sad to think that someone is going through a very simple, straightforward cosmetic injection with symptoms known for botulism,” Krishnan said.
In the United States, there are five different FDA-approved neurotoxins for cosmetic use. American Board of Cosmetic SurgeryBotox under the company Allergan; Dysport under the company Galderma; Jeuveau under the company Evolus; Daxxify under Revance Therapeutics and Xeomin under Merz Aesthetics. Suppliers buy these products directly from the company's manufacturers to ensure they get the right FDA-approved product, Krishnan said.
“So the best way to find a licensed provider is to go to the company's websites for these products — you go to the company's Allergan website, saying you want Botox, and Allergan should have a list of licensed providers that actually sell their products,” Krishnan said, adding that consumers can also find where to buy their products. It may be worth asking their suppliers what they can find.
“Counterfeit products are often quoted at very low prices, and it should be a suggestion to ask more questions about where that product was purchased, and patients have a right to know,” Krishnan said.
“Sometimes when the price is so good, this should be a tip,” she said. “Brand name Botox typically costs a certain amount. The price can vary a bit from clinic to clinic, depending on the practitioner and the location of the clinic, but if the price is cheap, I think it should be a flagship sometimes.
If the supplier isn't licensed, the manufacturer won't sell their product to them, says plastic surgeon Dr. Jimmy Sung, medical director of Tribeca beauty He treated patients who had negative reactions from previous cosmetic services in New York City.
“First of all, if you don't have a license, you can't legally take the drug. The manufacturer won't sell it to you,” said Sung.
Often, when fake Botox is sold, “the injector knows they're buying a fake,” Sung said. The fake person knows they are selling to someone who is not a board-certified plastic surgeon or a board-certified dermatologist.
Botox contains the neurotoxic protein botulinum toxin as a product, which when used in small doses can temporarily smooth various medical or cosmetic concerns such as underarm sweating, chronic migraines, overactive bladder or facial wrinkles.
“Botox and its equivalent brands provide a mild, precise and consistent dose of botulinum toxin, but over-the-counter products are not manufactured safely or have the same quality assurance, which can lead to overdose or ingestion,” said Dr. Michaels. Cameron, President and Founder Cameron Dermatology and assistant clinical professor of dermatology at Mount Sinai Health System in New York.
A large amount of botulinum toxin in the body can cause a rare but serious illness botulismor symptoms similar to the disease.
“Symptoms of botulism include muscle weakness, vision changes, slurred speech, trouble moving your eyes. If you start having trouble breathing, it's an emergency,” Cameron said.
“If you're getting Botox for sweat wrinkles, I personally recommend seeing a board-certified dermatologist. If you are taking Botox for your migraines, see a neurologist. If you're taking Botox for your bladder problems, go see your urologist,” Cameron said. “If you feel there is a risk or the pricing doesn't make sense, you can ask to see the bottle and inspect the botox bottle yourself.”
Sung says fake Botox can be cheaply made to be more potent, causing severe reactions, or spread more easily if injected under the skin, increasing the risk of travel. Other parts of the face or body that were not initially considered.
“Factories producing fake botox do not have very strict quality control. “They might have a bad batch that's a little bit more stretched, a little bit more aggressive than the next batch,” Sung said. It's no different than finding a bad batch of fentanyl or heroin on the street.
It appears that fake toxins used in cosmetics have been circulating on the market for some time, Sung said.
“I'm really surprised that it took 20 years for the FDA to come up with something. “Even though I've never seen it, I know it's happening,” he said. “I know because patients tell me.”
If a provider is hesitant or deceptive about sharing details about their training, credentials, or where they purchased the product, that behavior should be a “huge red flag” and patients should not be afraid to ask questions or reconsider whether they are in place. The right place to receive these types of treatment, Dr. Steven Williams, of American Society of Plastic Surgeonshe said in an email on Tuesday.
“Vendors who do not display the original bottle or packaging that Botox came in should be viewed with some suspicion,” Williams said. He added that laws on injecting drugs like Botox can vary somewhat from state to state, but in most states, nurses, physician assistants and physicians can administer Botox, but in some places nurses must be supervised by physicians when administering it. Needles.
“Patients should be suspicious if Botox injections are given in hotel rooms or at home. Generally, a highly qualified physician, physician assistant or nurse practitioner will work in a plastic surgeon's or dermatologist's office,” Williams said. “These providers are not only expert injectors of these types of drugs, but are prepared to manage potential complications and advise on the risks and benefits of these treatments.”
Other steps patients can take to find the right provider include checking patient reviews for the provider's practice and checking for side effects from Botox, such as slurred speech, difficulty breathing or double vision, says Dr. Cynthia Elliott, owner and primary care practitioner. Skin irritation in Florida, he said in an email on Tuesday.
“Read the non-5-star reviews to see what patients were unhappy with, and if there are a lot of seemingly legitimate bad results, skip that practice because there are so many better ones out there,” says Elliott.
Also, “check the before and after photos used on the provider's website to make sure they are their own patient photos. There is often a watermark on the photo so that it cannot be used to display results on another carrier's website. Be careful if they only have before and after photos printed by the manufacturer, “adding, “Make an appointment to consult with the provider to get their knowledge before entering treatment. Some practices allow you to interact with the main sales person during your consultation, which is a red flag.