The Medicines and Healthcare products Regulatory Agency (MHRA) has raised a safety warning following reports of rare cases of iatrogenic botulism associated with botulinum toxin type A (BoNT-A) products.
The MHRA warns that, in very rare cases, BoNT-A can spread beyond the injection site and cause potentially life-threatening botulism. The regulator shares that it has worked with manufacturers to update product information and patient information leaflets to better communicate this risk. The MHRA additionally notes that the likelihood of adverse reactions may be increased in patients with underlying neurological disorders, a history of dysphagia or aspiration, when high doses are administered or when products are used outside their licensed indications or injected into unapproved sites.
The MHRA reiterates the dangers of unlicensed and counterfeit botulinum toxin products, warning that products sourced outside regulated supply chains may not meet UK safety and quality standards and can significantly increase the risk of serious adverse events.
Dr Alison Cave, MHRA chief safety officer and pharmacologist, commented, “These strengthened warnings are an important reminder that, in rare cases, serious side effects can occur. It is vital that healthcare professionals and patients are aware of the symptoms of botulism and act quickly if they arise as this is a medical emergency. The MHRA continuously monitors the safety of these medicines, including side effects and emerging evidence.”