MHRA Safety Roundup: January 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 Isotretinoin – changes to prescribing guidance and additional risk minimisation measures
• Drug Safety Update on Improving Information Supplied with Gabapentinoids (Pregabalin/Gabapentin), Benzodiazepines and Z-Drugs
• Device Safety Information on M6-C Artificial Cervical Disc, Spinal Kinetics LLC: New monitoring requirements for the risk of osteolysis (DSI/2026/001)
• Letters, medicines recalls and device notifications sent to healthcare professionals in January 2026
• News and guidance on:
  • Statins: update to product information on the role of the nocebo effect in muscle-related events.
  • Increased semaglutide dose for adults with obesity – prescribing advice.
  • Epimax Ointment and Epimax Paraffin-Free Ointment: reports of ocular surface toxicity and ocular chemical injury.
  • MMRV vaccine factsheet published.
  • New MHRA guidance for healthcare professionals and the public on the use of mental health apps and technologies.