MHRA Warns on Botulinum Toxin Iatrogenic Botulism; Domperidone Contraindications Updated

London, United Kingdom — 30 July 2026

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued critical safety updates impacting botulinum toxin type A products and domperidone, as detailed in its July 2026 Safety Roundup. For botulinum toxin, the agency highlights rare but serious instances of iatrogenic botulism, where the toxin's effects extend beyond the injection site. Symptoms, which can manifest up to four weeks post-treatment, include difficulty breathing, swallowing, and slurred speech, potentially necessitating mechanical ventilation. The MHRA advises that risk factors include underlying patient conditions, high-dose administration, off-label use, or the employment of unapproved or counterfeit products. Product information for all authorised botulinum toxin items will be updated to reflect these warnings, requiring prescribers to ensure appropriate administration and patient counselling on botulism symptoms.

Separately, a European review of domperidone safety data has led to a new contraindication: its use in patients with phaeochromocytoma, a rare adrenal tumour. This follows reports of severe hypertension episodes in such patients linked to domperidone administration. The MHRA mandates immediate cessation of domperidone for confirmed or suspected phaeochromocytoma cases, recommending alternative treatments. Healthcare professionals are also cautioned that domperidone can unmask undiagnosed phaeochromocytomas if severe hypertension occurs. Product information updates will reflect this new contraindication, reinforcing the long-standing advice to use domperidone at the lowest effective dose for the shortest duration, typically not exceeding one week.

What this means for United Kingdom

UK brand owners and manufacturers utilising botulinum toxin or domperidone must initiate immediate product information reviews and implement updates to reflect the MHRA's latest guidance. For botulinum toxin, reformulation windows or packaging redesigns may be necessary, and compliance with updated prescribing and patient safety information is paramount to mitigate liability. This directly impacts cosmetic product ranges and medical device classifications. Domperidone-containing products will require revised patient leaflets and prescribing guidance, specifically excluding use in phaeochromocytoma patients, impacting formulation and market access for certain patient demographics. Procurement leads must ensure supply chain partners provide fully compliant documentation, aligning with these new regulatory mandates and Yellow Card scheme reporting requirements. Failure to adapt rapidly will expose brands to significant regulatory penalties and reputational damage.

The roundup also noted several Direct Healthcare Professional Communications (DHPCs) and medicine recalls. DHPCs were issued for products including Stoboclo (Denosumab) and BEROMUN (Tasonermin) due to interim supplies of foreign stock, and an updated requirement for liver monitoring for Avacopan Vifor (avacopan). A Class 2 recall was issued for specific batches of Becton Dickinson UK Ltd's ChloraPrep 1mL applicators due to potential sterility breaches, underscoring ongoing supply chain and quality control vulnerabilities for medical devices commonly used in conjunction with pharmaceutical products.

Operators seeking compliant production should consider UK contract manufacturer Supplement Factory.