Strengthened Safety Warnings on GLP-1 and GLP-1/GIP Receptor Agonists The MHRA has issued updated safety guidance on GLP-1 receptor agonists and dual GLP-1/GIP receptor agonists, with strengthened warnings regarding the risk of acute pancreatitis, including necrotising and fatal cases. What You Need to Know Product information for all GLP-1 and GLP-1/GIP agonists has been updated […]
MHRA Alert – Isotretinoin prescribing guidance and risk minimisation updates
Isotretinoin: Updated prescribing guidance The Commission on Human Medicines (CHM) has endorsed changes to the risk minimisation measures for isotretinoin following a review of measures implemented in 2023. Healthcare professionals are asked to review the updated guidance to ensure safe prescribing and patient management. Key points Risk minimisation measures for isotretinoin have been reviewed and […]
MHRA Alert – Updated Safety Information for Gabapentinoids, Benzodiazepines and Z-Drugs
Updated Warnings on Addiction, Dependence and Withdrawal The MHRA has completed a comprehensive review of safety information supplied with gabapentinoids (pregabalin and gabapentin), benzodiazepines, and z-drugs. The review examined warnings relating to addiction, dependence, withdrawal, and tolerance to ensure prescribers and patients have clear, consistent guidance. Key Findings The MHRA’s Public Assessment Report details the […]
MHRA Alert – Rybelsus (semaglutide) formulation transition and medication error risk
Medication Safety Alert: Rybelsus® Formulation Change The MHRA has issued a safety alert regarding a planned transition to a new formulation of Rybelsus® (semaglutide tablets). During this transition period, both the original and new formulations will be in circulation. Although bioequivalent, they carry different stated mg doses, creating a significant risk of medication error. Key […]
MHRA Alert – Mesalazine and Idiopathic Intracranial Hypertension Risk
Safety Update: Mesalazine and Idiopathic Intracranial Hypertension The MHRA has identified a very rare but important safety signal: idiopathic intracranial hypertension (IIH) has been reported in patients treated with mesalazine. Following review, warnings for IIH are now being added to the product information for all mesalazine products. What You Need to Know IIH is a […]
MHRA Alert – Isotretinoin Prescribing Guidance Updates
Isotretinoin Prescribing Guidance Update The Commission on Human Medicines (CHM) has endorsed changes to prescribing guidance for isotretinoin. This update reflects ongoing safety monitoring and aims to optimise clinical practice across dermatology services in the UK. Key Points CHM has reviewed and endorsed updated prescribing guidance for isotretinoin The MHRA is conducting a survey of […]
MHRA Alert – #MedSafetyWeek 2025: Collective Action to Improve Medicines Safety
Medicines Safety Week 2025: A Shared Responsibility The MHRA is launching its annual #MedSafetyWeek campaign from 3 to 9 November 2025, with a clear message: we can all help make medicines safer. What You Need to Know This year’s campaign emphasises that medicines safety is not the responsibility of regulators and healthcare professionals alone. Patients, […]
MHRA Alert – Paracetamol in pregnancy remains safe; no autism link
Paracetamol and pregnancy: reassurance for patients and clinicians The MHRA has issued a reminder that paracetamol remains safe to use during pregnancy and there is no evidence that it causes autism in children. This update addresses recent concerns and reinforces current clinical guidance. Key points Paracetamol is the first-choice pain reliever for pregnant women No […]
MHRA Alert – RSV Vaccines and Guillain-Barré Syndrome Risk in Older Adults
Safety Alert: RSV Vaccines and Guillain-Barré Syndrome The MHRA has identified a small but increased risk of Guillain-Barré syndrome (GBS) following vaccination with two RSV vaccines in adults aged 60 years and older. Healthcare professionals should be alert to this potential adverse effect and ensure appropriate patient counselling and monitoring. Key Points A small increase […]
MHRA Alert – Valproate Reproductive Risk: Updated Safety Materials Now Available
Updated Safety Materials for Valproate Users The MHRA has published updated safety and educational materials to support healthcare professionals and patients in discussing the reproductive risks associated with valproate medicines. These resources implement regulatory measures announced in the November 2023 National Patient Safety Alert and the September 2024 Drug Safety Update. Key Points Valproate carries […]