Health officials have warned of the threat posed by illegitimate Botox injections amid a wave of hospitalisations.
The harmful reactions are reportedly the result of counterfeit material or untrained injection administering. In New York, Health Department officials recorded three people were receiving treatment for various symptoms, including double vision, drooping eyelids, and difficulty swallowing, breathing and raising their arms.
The illnesses come amid CDC reports of illness among 22 individuals who had received botox injections in “non-healthcare settings" like homes and spas, 11 of which were sent to hospital for treatment. All are women aged 25 to 49, most around age 40.
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The New York City Health Department added that the three people who had to seek emergency treatment had received injections of botulinum toxin in their face, neck, upper back or armpits. Two were hospitalised and one was admitted to intensive care.
Some of the symptoms, including blurred vision and drooping eyelids, occurred near the injection site, while others were more widespread, including fatigue and generalised weakness. Other worrying symptoms include constipation, incontinence, dry mouth and difficult lifting the head, according to the FDA.
Dr Adam Friedman, dermatologist and chair of dermatology at George Washington University explained adverse reactions to legitimate Botox injections are usually the result of "poor technique" like injecting the toxin into the wrong muscle or in the wrong location. He added: "But if these patients might be going into respiratory distress or failure because of systemic poisoning, that's different from what doctors usually see."
Dr. Kate Dee, a physician and founder of Glow Medispa in Seattle, said the illnesses were the fault of unregulated medical spas, an industry now worth $15 billion (£12 billion). Dr Dee said: "The problem is not that there’s fake Botox around and doctors might accidentally use it.
"That’s not what’s happening. Doctors get real Botox, and we pay lots of money to do things legally and legitimately. It’s these people who are busy trying to make money from the med spa industry, the esthetics industry, who are getting it because it’s so much cheaper."
Counterfeit Botox-related cases have been recorded in California, Colorado, Florida, Illinois, Kentucky, Nebraska, New Jersey, New York, Tennessee, Texas and Washington. Health Commissioner Dr. Ashwin Vasan said: “New Yorkers should not be getting injections from friends or at parties, and they should not be getting them from non-medical professionals such as beauticians or aestheticians.
"A price that is too good to be true, or if a service provider does not explain the risks and side effects of the procedure, are clear warning signs that the products or services may not be legitimate and could pose a risk to your health.”
The FDA also laid out some clear giveaways to counterfeit Botox products:
- The outer carton and vial contain lot number C3709C3.
- The outer carton lists the active ingredient as “Botulinum Toxin Type A” instead of “OnabotulinumtoxinA.”
- The outer carton and vial indicate 150-unit doses, which is not a unit made by AbbVie.
- The outer carton's text is written in any language other than English.
The FDA added there is no indication that authentic Botox, from drugmaker AbbVie, is linked to any of the illnesses. Botox uses a purified form of the neurotoxin botulinum toxin that causes muscle paralysis.
The FDA has said it is "actively working" with state and federal health authorities to investigate the source of counterfeit Botox. Dr Friedman said: "The question is, is this 'faux-tox' all one and the same? Or are multiple people creating different versions of it? We don't know the answer to that."
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