MHRA safety roundup: September 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 Paracetamol and pregnancy - reminder that taking paracetamol during pregnancy remains safe
• Device Safety Information on Profemur Cobalt Chrome Modular Neck Hip Replacements: Higher than anticipated risk of revision surgery, metal-wear effects and component fracture
• Letters, medicines recalls and device notifications sent to healthcare professionals in September 2025 
• News and guidance on:
• Nitrofurantoin: reminder of the risks of pulmonary and hepatic adverse drug reactions
• Trodelvy: Update to SmPC and reminder of risk of serious side effects
• Valproate prescribing report published
• MHRA reassures the public that taking paracetamol during pregnancy remains safe
• MHRA investigating unlicensed Botox products
• New Commission launched to accelerate NHS use of AI
• MHRA and partners unite to reaffirm prescription weight loss medicine advertising rules