Important Safety Reminder: Amiodarone Monitoring Requirements Amiodarone is an effective antiarrhythmic agent, but it carries significant risks that demand careful patient supervision and regular monitoring. Healthcare professionals should ensure they are familiar with these risks and implement robust review protocols. Key Safety Concerns Amiodarone has been associated with serious and potentially life-threatening adverse effects affecting: […]
MHRA Alert – Finasteride and Dutasteride: Updated Psychiatric and Sexual Dysfunction Warnings
Updated Safety Warnings for Finasteride and Dutasteride The MHRA has completed a review of finasteride and dutasteride, two commonly prescribed medications for benign prostatic hyperplasia and male-pattern hair loss, and has identified important new safety information regarding psychiatric side effects and sexual dysfunction. Key Points The MHRA has reviewed evidence linking finasteride and dutasteride to […]
MHRA Alert – Nasal Decongestant Sprays: Rebound Congestion and Overuse Risk
MHRA Safety Update: Nasal Decongestant Sprays and Drops The MHRA has issued a safety alert regarding nasal decongestant sprays and drops containing xylometazoline hydrochloride and oxymetazoline hydrochloride. Reports indicate an increased risk of rebound congestion, rhinitis medicamentosa, and tachyphylaxis when these products are overused. What You Need to Know Rebound congestion: Nasal congestion worsens when […]
MHRA Alert – Falsified Mounjaro KwikPen 15mg Detected in UK
Safety Alert: Falsified Mounjaro Identified The MHRA has identified a falsified version of Mounjaro (tirzepatide) KwikPen 15mg solution for injection supplied through an online pharmacy in the UK. This alert applies to a specific batch and requires immediate awareness among clinical teams and patients. Key Points Falsified product identified with batch number D873576 Distribution traced […]
MHRA Alert – IXCHIQ Chikungunya Vaccine Temporarily Restricted in Adults Aged 65+
Temporary Suspension Notice The Commission on Human Medicines (CHM) has temporarily restricted the use of IXCHIQ Chikungunya vaccine in people aged 65 years and over following very rare but serious adverse events reported globally. This is a precautionary measure to allow further investigation. Key Points IXCHIQ should not be administered to patients aged 65 years […]
MHRA Alert – IXCHIQ Chikungunya vaccine: age restrictions updated following safety review
IXCHIQ Chikungunya vaccine: updated use restrictions The MHRA has completed a safety review of IXCHIQ (chikungunya vaccine) and, following recommendations from the Commission on Human Medicines (CHM), important changes to its licensed indications have been made. Key points IXCHIQ is no longer indicated for adults over 60 years of age The vaccine is now contraindicated […]
MHRA Alert – Semaglutide and Risk of Vision Loss (NAION)
Safety Alert: Semaglutide and Non-arteritic Anterior Ischemic Optic Neuropathy The MHRA has issued a safety update regarding a very rare but serious risk associated with semaglutide-containing medicines. Clinicians and responders should be aware of this potential adverse effect, particularly when counselling patients or assessing vision-related complaints. What is NAION? Non-arteritic anterior ischemic optic neuropathy (NAION) […]
MHRA Alert – GLP-1 Agonists: Strengthened Warnings on Acute Pancreatitis Risk
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 […]