Recent warning from UK authorities following adverse reactions to cosmetic procedures involving botulinum toxin

No evidence to-date of impact for Irish market but issue being closely monitored

The HPRA is aware of a recent safety alert issued by the UK Health Security Agency (UKHSA) warning people to be aware of the signs and symptoms of botulism. This warning was in response to a small number of individuals presenting to NHS healthcare settings following adverse reactions to cosmetic procedures involving botulinum toxin.

While UK investigations remain ongoing, the evidence to date suggests these cases are associated with the use of an unlicensed Botox-like product. 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.

Reactions reported have included:

• difficulty swallowing
• slurred speech
• breathing difficulty requiring respiratory support

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.

Botulinum toxin is a prescription-only medicine. As with all prescription-only medicines, it should only be sold or supplied:

• in accordance with a prescription given by an appropriate practitioner, such as a doctor;
• using product which has been authorised by the HPRA or the European Commission and sourced through an authorised wholesaler. 

The HPRA advice to those buying botulinum toxin, or seeking associated services, is 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.

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.

The HPRA advises 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.

Suspected adverse reactions can be notified to the HPRA via the national reporting scheme.