What aesthetic prescribers need to know about the MHRA’s Drug Safety Update (DSU) for botulinum toxin following iatrogenic botulism outbreak 

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a Drug Safety Update (DSU) for botulinum toxin following the outbreak of iatrogenic botulism reported between June and August 2025. 

The Joint Council for Cosmetic Practitioners (JCCP), with whom Hamilton Fraser works closely, is advising all registrants who prescribe, administer or work with botulinum toxin products to review the document, which introduces strengthened safety warnings for all botulinum toxin type A products.

Andrew Rankin, Acting Co-Chair, JCCP, comments, “The JCCP welcomes the MHRA’s robust response to the outbreak of iatrogenic botulism last year. We endorse all the advice offered by the MHRA in the Drug Safety Update and we encourage its adoption in the strongest terms.

“The events of last year were a serious challenge to public safety and they were avoidable. The JCCP expects to see the application of acceptable standards of sourcing, prescribing and administration of medicines under the forthcoming framework of licensing and its oversight and enforcement.”

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Key actions for practitioners

While botulinum toxin medicines continue to have a well-established safety profile when used appropriately, in very rare cases, the toxin's effects may spread beyond the injection site, resulting in botulism – a serious and potentially life-threatening medical emergency.

The JCCP therefore advises all practitioners using botulinum toxin products to:

• Check that the botulinum toxin product is authorised for use and follow the product-specific guidance in the product information for administration, dose and indication
• Make sure that anyone they direct to administer the product, including practitioners who may use it for cosmetic purposes, follows the directions on the prescription and that they are familiar with this Drug Safety Update (DSU) and the actions to be taken

The JCCP also recommends incorporating iatrogenic botulism into the informed consent process for patients undergoing treatment with botulinum toxin products.

Patients should be advised to seek immediate medical attention if they develop symptoms such as difficulty swallowing, slurred speech, breathing difficulties or muscle weakness following treatment. These symptoms may occur within days or up to four weeks after treatment.

The MHRA has also reiterated the importance of using only authorised botulinum toxin products obtained through regulated supply chains. Unlicensed or counterfeit products present significant risks to patient safety and do not meet UK safety and quality standards.

There is also an insurance dimension to consider. Medical malpractice cover is tied to lawful practice. Broadly, it applies when practitioners work with authorised products, prescribed and supplied through regulated channels, and treat within their scope of practice. Administering unlicensed or unauthorised products may affect your cover if a claim arises. If you have any doubt about whether a product or supplier meets policy requirements, check with your insurer before treating patients. This is general guidance rather than legal advice, and your individual circumstances always matter.

You can read Hamilton Fraser’s guide to grey market and counterfeit products and the full MHRA Drug Safety Update on gov.uk.

To discover how Hamilton Fraser can support you, you can speak to our specialist team on 0800 63 43 881 or get an online quote today.