Health officials in County Durham and Darlington are investigating botulism cases connected to counterfeit botulinum toxin.
Approximately 28 patients have fallen critically ill with botulism after receiving injections they believed were botulinum toxin, but are now suspected to have been counterfeit or improperly administered products. Reported symptoms span from ptosis and diplopia to dysphagia, slurred speech, lethargy and, in severe cases, respiratory distress.
The suspected product, an unlicensed substance called ‘Toxpia’ from South Korea, was illegally administered by unqualified beauticians operating in non-clinical salon settings. One patient, Kaylie Marie Bailey, experienced a severe adverse reaction, collapsing from respiratory failure. She was resuscitated at Sunderland Royal Hospital and subsequently treated with antitoxin in intensive care.
The UK Health Security Agency (UKHSA) has advised clinicians to suspect botulism in patients presenting neurological symptoms days to weeks after aesthetic treatments, and to administer antitoxin promptly. They indicate that this may be the largest outbreak of iatrogenic botulism in the UK in a century.
The Medicines and Healthcare Products Regulatory Agency (MHRA) and Allergan Aesthetics, an AbbVie company and trademark holder for Botox, are jointly investigating the illegal sales and distribution of counterfeit botulinum toxin, reinforcing that botulinum toxin is a prescription-only medication to be administered only by licensed healthcare professionals.
A spokesperson for Allergan Aesthetics, an AbbVie company, commented, “There are a growing number of unlicensed toxins flooding the UK market. Allergan Aesthetics collaborates with the Medicines & Healthcare Products Regulatory Agency (MHRA) to combat counterfeit products through the provision of training with trading standards officials for counterfeit identification, whilst our customers and Allergan Aesthetics employees have an important role in signaling suspicious activities to the MHRA enforcement units, customs and law enforcement.”
Discussing the recent botulism cases with Aesthetics, Catherine Fairris, president of the British College of Aesthetic Medicine (BCAM), commented, “The reports of botulism linked to the use of unlicensed botulinum toxin, such as ‘Toxpia’, are deeply alarming and sadly highlight a growing problem in the aesthetics field. The illicit trade in counterfeit and imported botulinum toxin products is being fuelled by individuals seeking to circumvent the legal prescribing requirements in the UK, often administering these substances in unsafe, non-clinical environments without appropriate medical oversight. These recent incidents underscore why urgent legislative reform is needed – not only to protect the public from unqualified and unscrupulous practitioners, but also to tackle the black market in prescription-only medicines.”
Amy Bird, nurse prescriber and chair of the British Association of Medical Aesthetic Nurses (BAMAN), also commented, “The Durham botulism cases linked to Toxpia are deeply alarming. This is an unlicensed substance, not a regulated medicine, and it has no place in medical aesthetics. BAMAN has repeatedly warned about the dangers of rogue practice and illegal imports. We urgently call on regulators to crack down on unsafe suppliers.”
