MHRA Safety Roundup: May 2026

Summary

The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and blood components for transfusion in the UK. This roundup provides a summary of their latest safety advice for medicines and medical device users. It includes details of medicine recalls, medical device field safety notices and details of how to report drug reactions and device incidents.

Content

This month's Safety Roundup includes: 

• Drug Safety Update on Nasal decongestant sprays and drops containing xylometazoline hydrochloride / oxymetazoline hydrochloride: increased risk of rebound congestion, rhinitis medicamentosa, and tachyphylaxis with overuse.
• Drug Safety Update on Finasteride and Dutasteride – updated safety warnings for psychiatric side effects and sexual dysfunction.
• Device safety Information on Kimal Procedure Packs containing recalled components: Namic Angiographic Syringe with the risk of syringe disconnection; Namic Manifolds with the risk of foreign particulates. Important guidance for use in urgent procedures where there are no alternatives.
• Device safety Information on Risk of severe harm from use of incorrect giving (administration) set for blood transfusion.
• Device safety Information on Allurion Gastric Balloon: Updated safety information due to the risks of gastric outlet obstruction, small bowel obstruction and gastric perforation.
• Letters, medicines recalls and device notifications sent to healthcare professionals in May 2026.
• News and guidance on:
• Dostarlimab (Jemperli) and immune-related skin adverse reactions: updates to the product information.
• BNF and BNFC updated guidance on medicines that cause drowsiness to help prevent co-sleeping deaths.