Drug safety
Drug safety alerts, for event medics.
When the MHRA publishes a drug safety alert, we summarise what changed and what it could mean for a patient at your event, with a link to the alert itself.
20 May 2026 · MHRA Drug Safety Update
MHRA Alert – Amiodarone: Essential Monitoring and Supervision Reminder
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. Amiodarone has been associated with…
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11 May 2026 · MHRA Drug Safety Update
MHRA Alert – Finasteride and Dutasteride: Updated Psychiatric and Sexual Dysfunction Warnings
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. The MHRA has reviewed…
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30 April 2026 · MHRA Drug Safety Update
MHRA Alert – Nasal Decongestant Sprays: Rebound Congestion and Overuse Risk
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. Rebound…
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24 February 2026 · MHRA Drug Safety Update
MHRA Alert – Falsified Mounjaro KwikPen 15mg Detected in UK
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. Falsified product identified with…
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11 February 2026 · MHRA Drug Safety Update
MHRA Alert – IXCHIQ Chikungunya Vaccine Temporarily Restricted in Adults Aged 65+
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. IXCHIQ should not be…
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11 February 2026 · MHRA Drug Safety Update
MHRA Alert – IXCHIQ Chikungunya vaccine: age restrictions updated following safety review
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. IXCHIQ is no longer indicated for adults over 60 years of age The vaccine is now…
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5 February 2026 · MHRA Drug Safety Update
MHRA Alert – Semaglutide and Risk of Vision Loss (NAION)
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. Non-arteritic…
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29 January 2026 · MHRA Drug Safety Update
MHRA Alert – GLP-1 Agonists: Strengthened Warnings on Acute Pancreatitis Risk
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. Product information for all GLP-1 and GLP-1/GIP agonists has been updated to…
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22 January 2026 · MHRA Drug Safety Update
MHRA Alert – Isotretinoin prescribing guidance and risk minimisation updates
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. Risk minimisation…
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8 January 2026 · MHRA Drug Safety Update
MHRA Alert – Updated Safety Information for Gabapentinoids, Benzodiazepines and Z-Drugs
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,…
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17 December 2025 · MHRA Drug Safety Update
MHRA Alert – Rybelsus (semaglutide) formulation transition and medication error risk
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…
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4 December 2025 · MHRA Drug Safety Update
MHRA Alert – Mesalazine and Idiopathic Intracranial Hypertension Risk
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. IIH is a rare neurological…
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27 October 2025 · MHRA Drug Safety Update
MHRA Alert – Isotretinoin Prescribing Guidance Updates
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. CHM has reviewed and endorsed updated prescribing guidance for…
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23 October 2025 · MHRA Drug Safety Update
MHRA Alert – #MedSafetyWeek 2025: Collective Action to Improve Medicines Safety
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. This year's campaign emphasises that medicines safety is not the responsibility of regulators and healthcare professionals alone. Patients, carers,…
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23 September 2025 · MHRA Drug Safety Update
MHRA Alert – Paracetamol in pregnancy remains safe; no autism link
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. Paracetamol is the first-choice pain reliever for pregnant women No…
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7 July 2025 · MHRA Drug Safety Update
MHRA Alert – RSV Vaccines and Guillain-Barré Syndrome Risk in Older Adults
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. A…
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10 June 2025 · MHRA Drug Safety Update
MHRA Alert – Valproate Reproductive Risk: Updated Safety Materials Now Available
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…
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15 May 2025 · MHRA Drug Safety Update
MHRA Alert – Thiopurines and Intrahepatic Cholestasis of Pregnancy
The MHRA has issued a safety update regarding a rare but serious risk associated with thiopurine medications in pregnant patients. Intrahepatic cholestasis of pregnancy (ICP) has been rarely reported in patients treated with azathioprine and is believed to be a risk applicable to all drugs in the…
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7 May 2025 · MHRA Drug Safety Update
MHRA Alert – Kaftrio: Psychological Side Effects in Cystic Fibrosis Treatment
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. Psychological side effects…
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24 April 2025 · MHRA Drug Safety Update
MHRA Alert – SABA Overuse in Asthma: Safety Reminder and Prescribing Guideline Changes
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.…
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10 April 2025 · MHRA Drug Safety Update
MHRA Alert – Fezolinetant (Veoza): Liver Injury Risk & Monitoring Guidance
The MHRA has issued new safety recommendations for fezolinetant (Veoza) following reports of drug-induced liver injury in patients receiving this treatment. Healthcare providers should be aware of this risk and implement appropriate monitoring protocols. Fezolinetant treatment carries a documented…
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12 March 2025 · MHRA Drug Safety Update
MHRA Alert – Prolonged-Release Opioids: Post-Operative Pain Indication Removed
The MHRA has removed the post-operative pain indication from all prolonged-release opioid medicines. This change reflects growing evidence of the risk of persistent post-operative opioid use (PPOU) and opioid-induced ventilatory impairment in this patient group. Prolonged-release opioid formulations…
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26 February 2025 · MHRA Drug Safety Update
MHRA Alert – January 2025 Medicine Recalls and Safety Notifications
The MHRA has published a summary of letters and notifications issued to healthcare professionals during January 2025 concerning medicines and medical devices. This update consolidates recent safety communications to help you stay informed of regulatory actions affecting clinical practice. This alert…
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13 February 2025 · MHRA Drug Safety Update
MHRA Alert – Valproate: Two-Specialist Review Now Required for New Patients Under 55
The Commission on Human Medicines (CHM) has clarified prescribing requirements for valproate, a medication used to treat epilepsy and other conditions. Two specialist reviews are now mandatory for all patients under 55 years of age initiating valproate, regardless of sex or gender. Male patients…
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28 January 2025 · MHRA Drug Safety Update
MHRA Alert – GLP-1 Agonists and Pulmonary Aspiration Risk During Anaesthesia
Healthcare professionals should be aware of a potential risk of pulmonary aspiration in patients taking GLP-1 or dual GIP/GLP-1 receptor agonists who undergo surgery or procedures requiring general anaesthesia or deep sedation. GLP-1 and GIP/GLP-1 receptor agonists are associated with delayed…
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28 January 2025 · MHRA Drug Safety Update
MHRA Alert – December 2024 Medicine Recalls and Safety Letters
The Medicines and Healthcare products Regulatory Agency (MHRA) has published a summary of letters and notifications issued to healthcare professionals during December 2024 concerning medicines and medical devices. This update consolidates recent safety communications to help you stay informed of…
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12 December 2024 · MHRA Drug Safety Update
MHRA Alert – November 2024 Medicine Recalls and Safety Letters
The MHRA has published a summary of letters and notifications issued to healthcare professionals throughout November 2024 concerning medicines and medical devices. This monthly round-up helps ensure all clinical teams remain informed of emerging safety issues and regulatory actions. The November…
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6 November 2024 · MHRA Drug Safety Update
MHRA Alert – MedSafetyWeek 2024: Yellow Card Reporting Campaign
The MHRA's ninth annual #MedSafetyWeek campaign runs from 4 to 10 November 2024. This year's focus emphasises the critical role that Yellow Card reports play in preventing future harm and improving patient safety across the UK. Every adverse drug reaction report submitted via the Yellow Card…
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6 November 2024 · MHRA Drug Safety Update
MHRA Alert – October 2024 Medicine Recalls and Safety Updates
The MHRA has published a summary of letters and notifications issued to healthcare professionals during October 2024 concerning medicines and medical devices. This monthly round-up ensures all clinical staff remain informed of important safety updates and product recalls. The MHRA regularly…
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24 October 2024 · MHRA Drug Safety Update
MHRA Alert – GLP-1 Receptor Agonists: Side Effects and Misuse Risk
The MHRA has issued a reminder for healthcare professionals regarding glucagon-like peptide-1 receptor agonists (GLP-1RAs). This update emphasises the importance of patient counselling on potential side effects and highlights emerging concerns around misuse of these medications. GLP-1RAs are…
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24 October 2024 · MHRA Drug Safety Update
MHRA Alert – Insulin Pumps and CGM Equipment: Report Safety Concerns via Yellow Card
The MHRA has published updated guidance to help users of insulin pumps and continuous glucose monitoring (CGM) equipment report suspected adverse incidents and safety concerns through the Yellow Card scheme. This guidance is aimed at: Users of insulin pumps and CGM devices Family members and…
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24 October 2024 · MHRA Drug Safety Update
MHRA Alert – Bromocriptine: Blood Pressure Monitoring Essential
The MHRA has issued a safety update following a Yellow Card report concerning bromocriptine prescribed for prevention or inhibition of post-partum physiological lactation. A safety review has concluded that blood pressure monitoring is essential when prescribing this medication. Bromocriptine…
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24 October 2024 · MHRA Drug Safety Update
MHRA Alert – September 2024 Letters and Medicine Recalls Summary
The MHRA has published a summary of letters and notifications issued to healthcare professionals during September 2024 concerning medicines and medical devices. This regular update ensures all clinical staff remain informed of important safety communications and product recalls. The September 2024…
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26 September 2024 · MHRA Drug Safety Update
MHRA Alert – August 2024 Medicine Recalls and Safety Updates
The MHRA has published a summary of letters and notifications issued to healthcare professionals during August 2024 concerning medicines and medical devices. This update consolidates recent safety communications to help you stay informed of regulatory actions affecting your practice. The August 2024…
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5 September 2024 · MHRA Drug Safety Update
MHRA Alert – Valproate Use in Men and Contraception Advice
The MHRA has issued a precautionary safety alert regarding valproate use in men. A retrospective observational study has identified a possible association between valproate use by men around the time of conception and an increased risk of neurodevelopmental disorders in their children. The alert…
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21 August 2024 · MHRA Drug Safety Update
MHRA Alert – Yellow Card Biobank study on genetic links to DOAC and allopurinol side effects
The MHRA is inviting healthcare professionals and patients to contribute to an important research initiative exploring the genetic basis of side effects associated with two commonly prescribed medication classes. The Yellow Card Biobank is a collaborative study designed to investigate whether…
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21 August 2024 · MHRA Drug Safety Update
MHRA Alert – July 2024 Medicine Recalls and Safety Letters
The Medicines and Healthcare products Regulatory Agency (MHRA) has published a summary of letters and notifications issued to healthcare professionals during July 2024. These communications cover a range of medicines and medical devices and include safety alerts, recalls, and important clinical…
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23 July 2024 · MHRA Drug Safety Update
MHRA Alert – Epimax Ointment: Risk of Eye Injury if Used on Face
The MHRA has issued a safety alert regarding Epimax Ointment and Epimax Paraffin-Free Ointment due to reports of ocular surface toxicity and ocular chemical injury. Both Epimax Ointment and Epimax Paraffin-Free Ointment can cause serious eye damage if applied to the face Cases of ocular surface…
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23 July 2024 · MHRA Drug Safety Update
MHRA Alert – June 2024 Medicine Recalls and Safety Letters
The Medicines and Healthcare products Regulatory Agency (MHRA) has published a summary of letters and notifications issued to healthcare professionals during June 2024. This update covers recent medicine recalls and safety communications affecting clinical practice. The MHRA regularly issues…
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20 June 2024 · MHRA Drug Safety Update
MHRA Alert – Topiramate: New Pregnancy Prevention Programme Requirements
The MHRA has introduced new safety measures for topiramate following a comprehensive review of its use in pregnancy. Topiramate is now contraindicated in pregnancy and in women of childbearing potential unless strict conditions are met. Topiramate carries a significant risk of birth defects and…
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20 June 2024 · MHRA Drug Safety Update
MHRA Alert – Warfarin and Tramadol: Critical Drug Interaction Risk
The MHRA has issued a safety alert regarding a significant drug interaction between warfarin and tramadol. This combination can cause harmful interactions that elevate the International Normalised Ratio (INR) and result in severe bruising, bleeding, and in some cases, fatal outcomes. Warfarin and…
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20 June 2024 · MHRA Drug Safety Update
MHRA Alert – May 2024 Medicine Recalls and Safety Updates
The MHRA has published a summary of letters and safety notifications issued to healthcare professionals during May 2024. This update covers recent medicines and medical device alerts that may affect your clinical practice and patient care. The MHRA regularly communicates important safety information…
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29 May 2024 · MHRA Drug Safety Update
MHRA Alert – Topical Steroids: New Labelling and Withdrawal Risk Reminder
The MHRA has issued an important reminder about topical steroid safety, with new labelling coming to products in the coming months. While these medications are safe and effective for managing inflammatory skin conditions, prolonged use—especially at high potency—carries significant risks that all…
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29 May 2024 · MHRA Drug Safety Update
MHRA Alert – April 2024 Medicine Recalls and Safety Updates
The MHRA has published a comprehensive summary of letters and safety notifications issued to healthcare professionals during April 2024. This update covers recent medicine recalls and device safety information relevant to clinical practice across all care settings. This monthly summary…
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29 April 2024 · MHRA Drug Safety Update
MHRA Alert – Finasteride: Psychiatric and Persistent Sexual Side Effects
The MHRA has issued a reminder about important side effects associated with finasteride, a commonly prescribed medication for male pattern baldness and benign prostatic hyperplasia. A new patient alert card is being introduced to raise awareness among men taking this drug. Finasteride carries a…
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29 April 2024 · MHRA Drug Safety Update
MHRA Alert – Montelukast and Neuropsychiatric Reactions in All Ages
The MHRA has issued a reminder about the risk of neuropsychiatric reactions associated with montelukast use. This alert applies to all patient groups, including children and adolescents, and reinforces previous safety communications on this issue. Neuropsychiatric reactions have been reported in…
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29 April 2024 · MHRA Drug Safety Update
MHRA Alert – March 2024 Medicine Recalls and Safety Updates
The MHRA has published a summary of letters and notifications issued to healthcare professionals during March 2024 concerning medicines and medical devices. This update consolidates important safety information relevant to clinical practice across primary and secondary care. Multiple safety…
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27 March 2024 · MHRA Drug Safety Update
MHRA Alert – February 2024 Medicine Recalls & Safety Updates
The MHRA has published a summary of letters and notifications issued to healthcare professionals during February 2024. This update covers important safety information on medicines and medical devices that may affect your clinical practice and patient care. Regular safety alerts from the MHRA help…
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20 February 2024 · MHRA Drug Safety Update
MHRA Alert – Codeine Linctus Reclassified to Prescription-Only Medicine
The MHRA has reclassified codeine linctus (codeine oral solutions) from a general sales list (GSL) medicine to a prescription-only medicine (POM). This change follows a public consultation and reflects updated safety considerations for this commonly used cough suppressant. Codeine linctus can no…
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20 February 2024 · MHRA Drug Safety Update
MHRA Alert – Pseudoephedrine and Risk of PRES and RCVS
The MHRA has issued a safety alert regarding very rare reports of serious neurological conditions associated with pseudoephedrine use. Very rare cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported in patients taking…
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20 February 2024 · MHRA Drug Safety Update
MHRA Alert – January 2024 Medicine Recalls and Safety Updates
The MHRA has published a summary of letters and notifications issued to healthcare professionals during January 2024 concerning medicines and medical devices. This update consolidates important safety information relevant to prescribers, dispensers, and clinical teams across all settings. The…
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22 January 2024 · MHRA Drug Safety Update
MHRA Alert – Valproate Safety Materials for Under-55s
The MHRA has published new safety and educational materials for valproate-containing medicines to support regulatory measures protecting men and women under 55 years of age from serious harm. Valproate carries a significant risk of serious birth defects and developmental disorders if taken during…
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22 January 2024 · MHRA Drug Safety Update
MHRA Alert – Fluoroquinolone Antibiotics: Restricted Prescribing Now in Effect
The MHRA has issued updated guidance on systemic fluoroquinolone antibiotics, effective immediately. These agents must now be prescribed only when other commonly recommended antibiotics are inappropriate. Following a comprehensive safety review, fluoroquinolones are no longer considered first-line…
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