MHRA Safety Roundup: December 2025

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 Mesalazine and idiopathic intracranial hypertension
• Drug Safety Update on Rybelsus ® (semaglutide tablets): transition to new formulation and risk of medication error
• Letters, medicines recalls and device notifications sent to healthcare professionals in December 2025
• News and guidance on:
  • Patient and family experiences inform antidepressant safety information review
  • Vaccine factsheet published
  • Call for evidence: Regulation of AI in Healthcare
  • MHRA updates guidance on the Health Institution Exemption to support safe use of medical devices
  • MHRA host workshop to improve Patient Information Leaflets