Between July 4 and 14, a total of 38 cases of iatrogenic botulism were reported to UK health authorities
The Irish health products watchdog has said it is closely monitoring the potential use of unlicensed Botox-like products here after health officials in the UK were notified of people suffering adverse reactions to cosmetic procedures.
Last month the UK Health Security Agency warned the public to be aware of the signs and symptoms of botulism, after a small number of individuals presented to NHS healthcare settings following adverse reactions after receiving cosmetic procedures involving botulinum toxin.
Between July 4 and 14, a total of 38 cases of iatrogenic botulism were reported to British health authorities. Symptoms seen in affected patients have included difficulty swallowing, slurred speech, and breathing difficulty that required respiratory support.
This week the Health Products Regulatory Authority (HPRA) said that while it has not been notified of similar cases here, it is liaising with UK officials to assess any potential risk for the Irish public.
It advised any member of the public who has been treated with botulinum toxin, including those treated outside of a health service setting, to contact their doctor and seek medical attention immediately if they experience difficulties breathing, swallowing, or speaking.
“While UK investigations remain ongoing, the evidence to date suggests these cases are associated with the use of an unlicensed Botox-like product,” a HPRA statement said.
“It is understood that the UK-based practitioners involved in administering the unlicensed product have ceased providing the procedure and are co-operating with the ongoing investigation.”
The statement added: “At this time, there is no evidence of this issue impacting the Irish market and, to date, the HPRA has not been notified of any similar reports of adverse reactions occurring in Ireland.
“However, the HPRA is monitoring this situation closely and will continue to engage with relevant authorities in the UK and, at a national level, with Revenue’s Customs Service and other health system partners, to assess any potential impact.”
Medicines that contain botulinum toxin are prescription-only products. It is illegal to supply these without a prescription.
In recent years the HPRA detained record numbers of products purporting to contain botulinum toxin as part of a range of illegal medicines seized by the watchdog.
Last year 1,709 products alleging to include the substance were seized, compared to just 26 in 2020.
The HPRA said that sourcing this medicine in any other circumstances outside of the legal supply chain significantly increases the risk of getting a falsified or unlicensed product.
“This means that there are no safeguards to ensure such products meet the legal standards for quality and safety, and they may pose a serious risk to public health,” the HPRA statement said.
“As part of its enforcement remit, the HPRA works to identify those involved in the illegal trade in medicines and it takes robust regulatory action where necessary. This can include criminal prosecution.”
