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 […]
MHRA Alert – Thiopurines and Intrahepatic Cholestasis of Pregnancy
Safety Update: Thiopurine Use in Pregnancy The MHRA has issued a safety update regarding a rare but serious risk associated with thiopurine medications in pregnant patients. What You Need to Know Intrahepatic cholestasis of pregnancy (ICP) has been rarely reported in patients treated with azathioprine and is believed to be a risk applicable to all […]
MHRA Alert – Kaftrio: Psychological Side Effects in Cystic Fibrosis Treatment
Safety Update: Kaftrio Psychological Side Effects The MHRA has issued a safety update regarding psychological side effects reported in patients with cystic fibrosis treated with Kaftrio. While these effects are infrequent, healthcare professionals should be aware of the risk profile and monitor patients accordingly. Key Points Psychological side effects including anxiety, low mood, sleep disturbance, […]
MHRA Alert – SABA Overuse in Asthma: Safety Reminder and Prescribing Guideline Changes
MHRA Safety Reminder: Short-Acting Beta 2 Agonist Overuse Healthcare professionals and patients are reminded of the significant risks associated with overuse of short-acting beta 2 agonists (SABA) in asthma management. The MHRA has issued this alert to reinforce existing safety guidance and highlight recent changes to SABA prescribing recommendations. Key Safety Points Overuse of SABA—with […]