Plastic surgeons issue warning against counterfeit Botox

• Eleven women were hospitalized after being treated by unlicensed providers
• Reported symptoms include fatigue, weakness and even difficulty breathing
• In high doses, botulinum toxin – Botox’s ‘magic ingredient’ – can be fatal 

Doctors and government agencies are sounding the alarm after 22 women suffered adverse reactions from counterfeit Botox, which landed half of them in the hospital.

As of April 18, 22 people from 11 states have reported harmful reactions after receiving injections of the popular filler from unlicensed or untrained providers, according to the Centers for Disease Control and Prevention.

None of the women underwent the procedure in a medical setting – instead describing getting Botox in spas and at home.

The harmful reactions were reported between November 4, 2023, and March 31, 2024, in a slew of states including California, Colorado, Florida, Illinois, Kentucky, Nebraska, New Jersey, New York, Tennessee, Texas and Washington.

Aside from untrained people administering Botox, the issue goes even deeper – to the point where licensed medical professionals are being targeted by manufacturers peddling counterfeit product.

‘We are being contacted weekly by third-party companies that offer us Botox and fillers for a fraction of the price,’ said Dr. Akis Ntonos, co-founder of Aion Aesthetics, a leading aesthetic clinic based in New York.

Medical professionals and government agencies in the United States are warning consumers against receiving Botox from unlicensed providers after a rash of hospitalizations. (Pictured: a licensed professional injects cosmetic filler)

A lot number of C3709 also indicates a fake

The ‘magic ingredient’ in Botox is a toxin produced by the bacterium Clostridium botulinum. Hence the brand name – a portmanteau of ‘botulinum’ and ‘toxin.’

According to the World Health Organization, these toxins are among the deadliest in the world – but only small, localized doses are used in treatments, meaning side effects are usually minimal and temporary.

‘We call it a neuromodulator,’ Ntonos explained. ‘Basically, it interrupts the pathways between your brain and the receptors in your muscles.’

The toxin prevents the release of acetylcholine, a neurotransmitter, from axon endings in the brain, causing muscle paralysis – and leading to the appearance of smoothed wrinkles.

Botox uses a sterile, freeze-dried form of botulinum toxin type A that meets medical control standards. The effects can last anywhere from three to 12 months.

And it has proven popular in the United States, with 8,736,591 people receiving Botox or similar treatments in 2022, according to the American Society of Plastic Surgeons.

But this high demand begets other problems. Last May, U.S. Customs and Border Protection announced that officers in Cincinnati had seized 78 shipments of unapproved injectables over a two-week period.

The product was traveling from Bulgaria, Spain, China and Korea to U.S. states including Florida and New York, where adverse reactions have been reported.

Botox, a portmanteau of ‘botulinum’ and ‘toxin’, uses a sterile, freeze-dried form of botulinum toxin type A that interrupts neural signals to paralyze muscles

Dr. Akis Ntonos, co-founder of Aion Aesthetics, told DailyMail.com that manufacturers of unapproved injectables reach out to his office ‘weekly’

Ntonos told DailyMail.com that counterfeit fillers may go for anywhere between a fifth to an eighth of the price charged by Allergan, the manufacturer of Botox.

‘So, you can imagine, that’s very appealing to some practices,’ he said.

But unapproved products may contain unpurified or perilously high doses of botulinum toxin, or possibly none of the drug at all – and results can be catastrophic.

People have reported blurry and double vision, drooping eyelids, difficulty swallowing, dry mouth, slurred speech, fatigue and weakness – and, in the most extreme cases, difficulty breathing.

In 20 of the 22 cases announced last month, 11 women were hospitalized and six were treated with botulism antitoxin due to concerns that the toxin had spread beyond the injection site.

Of seven people tested for botulism – which can be fatal – six were negative. Results for one person are still pending.

The women ranged from 25 to 59 years old, with a median age of 41 years. Twenty reported receiving botulinum toxin injections for cosmetic purposes.

Troublingly, all of the women reported receiving the injections from unlicensed or untrained people or in non-healthcare settings.

The rash of hospitalizations sparked concern from government agencies, and the U.S. Food and Drug Administration alerted consumers to the sale of counterfeit Botox on April 18.

The report included photos of counterfeit packaging showing that many, if not all of the products were stamped with the name ‘Allergan’ – the real manufacturer of Botox.

Eleven women were hospitalized, some as recently as March, after receiving suspected counterfeit fillers (pictured). Six of these women were treated with botulism antitoxin. Pictured: Counterfeit Botox boxes

Some fake packaging features a distinctive holographic firework pattern on the box (pictured)

The authentic product is sold only in 50-, 100- and 200-unit dose forms

The authentic product is sold only in 50-, 100- and 200-unit dose forms. Any language other than English on the packaging should also raise red flags

But according to the FDA, there are warning signs.

AbbVie, which acquired Allergan in 2020, sells the authentic products in 50-, 100- and 200-unit dose forms. Counterfeits may be dosed into an easily distinguishable 150 units.

The manufacturer should be listed as either ‘Allergan Aesthetics / An AbbVie Company’ or ‘abbvie’ on the outer carton, and FDA-approved Botox displays the active ingredient as ‘OnabotulinumtoxinA’ on the outer carton and vial.

Counterfeit packaging, meanwhile, lists the active ingredient as ‘Botulinum Toxin Type A’ and brands the product as either ‘BOTOX® COSMETIC / onabotulinumtoxinA / for Injection’ or ‘OnabotulinumtoxinA / BOTOX® / for injection.’

Other giveaways are an outer carton and vial containing the lot number C3709C3, or an outer carton in any language other than English.

Some of the most recent counterfeits also feature a distinctive holographic firework pattern on the box.

A simple Google search uncovers a clamoring sea of competitors, all trying to pass their product off as genuine in order to turn a profit.

‘Botox 100IU is produced by Allergan – a leading company in the pharmaceutical industry,’ reads one Turkish-language website for a company purportedly based in South Korea.

‘It has undergone multiple testings, and after a set of researches, Botox demonstrates amazing results.’

Another site based in India promises 48-hour shipping for a product labelled ‘Botulinum Type A – Botox Cosmetic’ on the box, which also bears the Allergan logo.

Reported adverse reactions include double vision, drooping eyelids, difficulty swallowing, dry mouth, slurred speech, fatigue, and weakness. In the most extreme cases, difficulty breathing has been recorded

So what makes counterfeit Botox so dangerous? Medical professionals say it is difficult to pare down to one reason.

‘In the vial, there might be the actual neuromodulator, but the problem is, those toxins are temperature dependent,’ Ntonos explained.

‘If something is shipped overseas in a container and the temperature is not consistent over time, that’s when we can have problems. It doesn’t matter just what’s in the vial, because it could be a combination of black-market chemicals. We don’t know.’

Hence, the root of the problem – in many cases, consumers and providers alike simply don’t know what they’re buying. This includes medical professionals whose practices are striving to cut costs.

Manufacturers know it, too, and some will go out of their way to target those who are licensed to perform the procedure.

‘They see if they can find me online, they see that they’re doing injectables. So I’m an easy target for them,’ Ntonos said.

‘Like, “Oh, this person pays $10 for their Botox and now I can give it to you for $4.” Why would they say no? Right? And let me tell you, even medical professionals will buy the cheaper product.’

While the offer may seem enticing, it comes at a far more costly price – the revocation of a medical license, which is required to administer Botox in the first place.

This leads to an even larger issue, which the CDC alluded to in their report. Aestheticians, who often work in spas and beauty salons, cannot legally offer the drug.

‘When we go to conferences, we try to speak about this issue a lot, because in the market, especially in New York City, people see a big range of prices with Botox or fillers,’ Ntonos said.

‘Botox is an FDA-approved drug. No matter how much we buy as providers, it’s illegal for companies to discount the product for us. A lot of people tell me, “Oh, my provider buys a lot of product, so they get it for cheaper.” That’s a red flag.’

Ntonos urges clients to find a doctor they trust rather than ‘shopping for prices’. Aestheticians, who operate in spas and beauty salons, are not licensed to perform the procedure

The FDA is currently working with AbbVie to investigate suspected counterfeit Botox products found in the United States.

The agency advises consumers to ask their provider if they are licensed and trained to administer the drug, and to confirm that they are receiving a product from an authorized source.

Ntonos encourages clients to be wary if a practice doesn’t offer a rewards program associated with pharmaceutical manufacturers. These include Allē for Allergan and ASPIRE for Galderma, among others.

The most important tip of all? Know your doctor.

‘I tell people you need to find someone you trust and you need to interview them and you need to build a relationship,’ Ntonos said.

‘And once you find this person, you need to trust them. Don’t shop for prices. This is a medical service. If you went for a surgery, you wouldn’t look for the cheapest price – you’d look for the best outcome.’

Botox is by no means a cheap service, Ntonos continued.

‘If this is something out of your price range right now, don’t do it now. Save the money and do it in the future. And have a better outcome than risking paying maybe half the price for something that’s illegal.’

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