tag:www.gov.uk,2005:/drug-safety-updateDrug Safety Update2026-05-20T15:48:04+01:00HM Governmenttag:www.gov.uk,2005:/drug-safety-update/amiodarone-cordarone-x-reminder-of-risks-of-treatment-and-need-for-patient-monitoring-and-supervision2026-05-20T15:48:04+01:00Amiodarone: reminder of risks of treatment and need for patient monitoring and supervisionAmiodarone has been associated with serious and potentially life-threatening side effects, particularly of the lung, liver, and thyroid gland. We remind healthcare professionals that patients should be supervised and reviewe…tag:www.gov.uk,2005:/drug-safety-update/finasteride-and-dutasteride-updated-safety-warnings-for-psychiatric-side-effects-and-sexual-dysfunction2026-05-11T14:29:47+01:00Finasteride and Dutasteride – updated safety warnings for psychiatric side effects and sexual dysfunctionThe MHRA has reviewed the evidence for finasteride and dutasteride and the risk of suicidal thoughts and behaviours and has recommended further measures to minimise this risk. tag:www.gov.uk,2005:/drug-safety-update/nasal-decongestant-sprays-and-drops-containing-xylometazoline-hydrochloride-slash-oxymetazoline-hydrochloride-increased-risk-of-rebound-congestion-rhinitis-medicamentosa-and-tachyphylaxis-with-overuse2026-04-30T14:01:45+01:00Nasal decongestant sprays and drops containing xylometazoline hydrochloride / oxymetazoline hydrochloride: increased risk of rebound congestion, rhinitis medicamentosa, and tachyphylaxis with overuse There have been reports of worsening nasal congestion (rebound congestion) when the effects of nasal decongestant sprays or drops containing xylometazoline hydrochloride and oxymetazoline hydrochloride, wear off.tag:www.gov.uk,2005:/drug-safety-update/falsified-mounjaro-kwikpen-15mg-pre-filled-pens2026-02-24T14:00:08+00:00Falsified Mounjaro KwikPen 15mg pre-filled pens A falsified version of Mounjaro (tirzepatide) KwikPen 15mg solution for injection has been found supplied through one online pharmacy in the UK. The falsified product is labelled with batch D873576 and applies to Mounjaro Kw…tag:www.gov.uk,2005:/drug-safety-update/ixchiq-chikungunya-vaccine-temporary-suspension-in-people-aged-65-years-or-older2026-02-11T15:01:50+00:00IXCHIQ Chikungunya vaccine: temporary suspension in people aged 65 years or olderThe Commission on Human Medicines (CHM) has temporarily restricted use of the IXCHIQ Chikungunya vaccine in people aged 65 years and over following very rare fatal reactions reported globally. This is a precautionary measure…tag:www.gov.uk,2005:/drug-safety-update/ixchiq-chikungunya-vaccine-updates-to-restrictions-of-use-following-safety-review2026-02-11T13:59:13+00:00IXCHIQ Chikungunya vaccine: updates to restrictions of use following safety reviewFollowing the completion of a safety review and the recommendations of the Commission on Human Medicines (CHM), the IXCHIQ Chikungunya vaccine is no longer indicated for adults over the age of 60 years, and is contraindicate…tag:www.gov.uk,2005:/drug-safety-update/semaglutide-wegovy-ozempic-and-rybelsus-risk-of-non-arteritic-anterior-ischemic-optic-neuropathy-naion2026-02-05T13:24:42+00:00Semaglutide (Wegovy, Ozempic and Rybelsus): risk of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION)Non-arteritic anterior ischemic optic neuropathy (NAION), a condition that can cause sudden deterioration in vision, usually in one eye at a time, has been very rarely reported in association with semaglutide in the treatmen…tag:www.gov.uk,2005:/drug-safety-update/glp-1-receptor-agonists-and-dual-glp-1-slash-gip-receptor-agonists-strengthened-warnings-on-acute-pancreatitis-including-necrotising-and-fatal-cases2026-01-29T14:07:50+00:00GLP-1 receptor agonists and dual GLP-1/GIP receptor agonists: strengthened warnings on acute pancreatitis, including necrotising and fatal casesThe product information for all Glucagon-Like Peptide-1 (GLP-1) receptor agonists and dual GLP-1/glucose-dependent insulinotropic polypeptide (GIP) receptor agonists has been further updated to highlight the potential risk o…tag:www.gov.uk,2005:/drug-safety-update/isotretinoin-changes-to-prescribing-guidance-and-additional-risk-minimisation-measures2026-01-22T16:15:32+00:00Isotretinoin – changes to prescribing guidance and additional risk minimisation measuresThe Commission on Human Medicines (CHM) has endorsed changes to the risk minimisation measures for isotretinoin, following a review of the impact of the measures implemented in 2023. We ask healthcare professionals to review…tag:www.gov.uk,2005:/drug-safety-update/improving-information-supplied-with-gabapentinoids-pregabalin-slash-gabapentin-benzodiazepines-and-z-drugs2026-01-08T11:01:39+00:00Improving Information Supplied with Gabapentinoids (Pregabalin/Gabapentin), Benzodiazepines and Z-DrugsThe MHRA has reviewed the warnings regarding addiction, dependence, withdrawal, and
tolerance for gabapentin, pregabalin, benzodiazepines, and z-drugs. The findings (detailed in the Public Assessment Report) were that it wa…tag:www.gov.uk,2005:/drug-safety-update/rybelsus-r-semaglutide-tablets-transition-to-new-formulation-and-risk-of-medication-error2025-12-17T14:17:47+00:00Rybelsus ® (semaglutide tablets): transition to new formulation and risk of medication errorThere is a risk of patient harm arising through medication error during a transition period where the original and new formulation of Rybelsus ® tablets, which have different stated mg doses but are bioequivalent, will both …tag:www.gov.uk,2005:/drug-safety-update/mesalazine-and-idiopathic-intracranial-hypertension2025-12-04T14:00:32+00:00Mesalazine and idiopathic intracranial hypertensionIdiopathic intracranial hypertension (IIH) has been very rarely reported in patients treated with mesalazine. Following a recent review, warnings for IIH are being added to the product information for all mesalazine products…tag:www.gov.uk,2005:/drug-safety-update/isotretinoin-updates-to-prescribing-guidance-and-survey-of-services2025-10-27T11:00:14+00:00Isotretinoin – updates to prescribing guidance and survey of servicesThe Commission on Human Medicines (CHM) has endorsed changes to isotretinoin prescribing guidance. In addition, CHM is seeking further information from dermatology services who prescribe isotretinoin to inform any future cha…tag:www.gov.uk,2005:/drug-safety-update/number-medsafetyweek-3-9-november-2025-a-call-to-action-to-improve-patient-safety2025-10-23T14:00:13+01:00#MedSafetyWeek (3-9 November 2025): A call to action to improve patient safetyThe annual #MedSafetyWeek campaign takes place from 3 to 9 November 2025. This year’s campaign theme is ‘we can all help make medicines safer.’tag:www.gov.uk,2005:/drug-safety-update/paracetamol-and-pregnancy-reminder-that-taking-paracetamol-during-pregnancy-remains-safe2025-09-23T17:41:18+01:00Paracetamol and pregnancy - reminder that taking paracetamol during pregnancy remains safePatients should be reminded and reassured that there is no evidence that taking paracetamol during pregnancy causes autism in children. Paracetamol is recommended as the first-choice pain reliever for pregnant women, used at…tag:www.gov.uk,2005:/drug-safety-update/abrysvov-pfizer-rsv-vaccine-and-arexvyv-gsk-rsv-vaccine-be-alert-to-a-small-risk-of-guillain-barre-syndrome-following-vaccination-in-older-adults2025-07-07T13:29:13+01:00Abrysvo▼ (Pfizer RSV vaccine) and Arexvy▼ (GSK RSV vaccine): be alert to a small risk of Guillain-Barré syndrome following vaccination in older adultsThere is a small increase in the risk of Guillain-Barré syndrome following vaccination with Abrysvo (Pfizer respiratory syncytial virus (RSV) vaccine) and Arexvy (GSK RSV vaccine) in adults aged 60 years and older. Healthca…tag:www.gov.uk,2005:/drug-safety-update/valproate-belvo-convulex-depakote-dyzantil-epilim-epilim-chrono-or-chronosphere-episenta-epival-and-syonellv-updated-safety-and-educational-materials-to-support-patient-discussion-on-reproductive-risks2025-06-10T12:02:24+01:00Valproate (Belvo, Convulex, Depakote, Dyzantil, Epilim, Epilim Chrono or Chronosphere, Episenta, Epival, and Syonell▼): updated safety and educational materials to support patient discussion on reproductive risksUpdated safety and educational materials are now available to support the implementation of the regulatory measures announced in the November 2023 National Patient Safety Alert and the September 2024 Drug Safety Update. They…tag:www.gov.uk,2005:/drug-safety-update/thiopurines-and-intrahepatic-cholestasis-of-pregnancy2025-05-15T11:30:20+01:00Thiopurines and intrahepatic cholestasis of pregnancy Intrahepatic cholestasis of pregnancy (ICP) has been rarely reported in patients treated with azathioprine products and is believed to be a risk applicable to all drugs in the thiopurine class (azathioprine, mercaptopurine a…tag:www.gov.uk,2005:/drug-safety-update/kaftriov-ivacaftor-tezacaftor-elexacaftor-risk-of-psychological-side-effects2025-05-07T13:59:47+01:00Kaftrio▼ (Ivacaftor, tezacaftor, elexacaftor): risk of psychological side effectsPsychological side effects such as anxiety, low mood, sleep disturbance, poor concentration, and forgetfulness have been infrequently reported in people with cystic fibrosis treated with Kaftrio. Healthcare professionals sho…tag:www.gov.uk,2005:/drug-safety-update/short-acting-beta-2-agonists-saba-salbutamol-and-terbutaline-reminder-of-the-risks-from-overuse-in-asthma-and-to-be-aware-of-changes-in-the-saba-prescribing-guidelines2025-04-24T12:02:48+01:00Short-acting beta 2 agonists (SABA) (salbutamol and terbutaline): reminder of the risks from overuse in asthma and to be aware of changes in the SABA prescribing guidelinesHealthcare professionals and patients are reminded of the risk of severe asthma attacks and increased mortality associated with overuse of SABA with or without anti-inflammatory maintenance therapy in patients with asthma. H…tag:www.gov.uk,2005:/drug-safety-update/fezolinetantv-veoza-risk-of-liver-injury-new-recommendations-to-minimise-risk2025-04-10T12:00:08+01:00Fezolinetant▼(Veoza): risk of liver injury; new recommendations to minimise riskFezolinetant treatment is associated with a risk of drug induced liver injury. New recommendations have been introduced to minimise this risk. Liver function should be monitored before and during treatment in all patients ta…tag:www.gov.uk,2005:/drug-safety-update/prolonged-release-opioids-removal-of-indication-for-relief-of-post-operative-pain2025-03-12T11:02:10+00:00Prolonged-release opioids: Removal of indication for relief of post-operative painThe indication for the treatment of post-operative pain has been removed from the licences of all prolonged release opioids due to the increased risk of persistent post-operative opioid use (PPOU) and opioid-induced ventilat…tag:www.gov.uk,2005:/drug-safety-update/letters-and-medicine-recalls-sent-to-healthcare-professionals-in-january-20252025-02-26T14:02:39+00:00Letters and medicine recalls sent to healthcare professionals in January 2025A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices. tag:www.gov.uk,2005:/drug-safety-update/valproate-belvo-convulex-depakote-dyzantil-epilim-epilim-chrono-or-chronosphere-episenta-epival-and-syonellv-review-by-two-specialists-is-required-for-initiating-valproate-but-not-for-male-patients-already-taking-valproate2025-02-13T15:02:39+00:00Valproate (Belvo, Convulex, Depakote, Dyzantil, Epilim, Epilim Chrono or Chronosphere, Episenta, Epival, and Syonell▼): review by two specialists is required for initiating valproate but not for male patients already taking valproateReview by two specialists remains in place for patients initiating valproate under 55 years of age but the Commission on Human Medicines (CHM) has advised that it will not be required for men (or males) currently taking valp…tag:www.gov.uk,2005:/drug-safety-update/glp-1-and-dual-gip-slash-glp-1-receptor-agonists-potential-risk-of-pulmonary-aspiration-during-general-anaesthesia-or-deep-sedation2025-01-28T14:00:20+00:00GLP-1 and dual GIP/GLP-1 receptor agonists: potential risk of pulmonary aspiration during general anaesthesia or deep sedation Healthcare professionals should be aware of the potential risk of pulmonary aspiration in patients using GLP-1 or dual GIP/GLP-1 receptor agonists who undergo surgery or procedures with general anaesthesia or deep sedation.tag:www.gov.uk,2005:/drug-safety-update/letters-and-medicine-recalls-sent-to-healthcare-professionals-in-december-20242025-01-28T14:00:09+00:00Letters and medicine recalls sent to healthcare professionals in December 2024A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices. tag:www.gov.uk,2005:/drug-safety-update/letters-and-medicine-recalls-sent-to-healthcare-professionals-in-november-20242024-12-12T11:00:40+00:00Letters and medicine recalls sent to healthcare professionals in November 2024A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.tag:www.gov.uk,2005:/drug-safety-update/medsafetyweek-november-2024-your-yellow-card-report-helps-prevent-future-harm-to-others-and-improves-patient-safety2024-11-06T12:01:42+00:00MedSafetyWeek November 2024: your Yellow Card report helps prevent future harm to others and improves patient safetyThe ninth annual #MedSafetyWeek social media campaign is taking place 4 to 10 November 2024. tag:www.gov.uk,2005:/drug-safety-update/letters-and-medicine-recalls-sent-to-healthcare-professionals-in-october-20242024-11-06T12:01:37+00:00Letters and medicine recalls sent to healthcare professionals in October 2024 A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.tag:www.gov.uk,2005:/drug-safety-update/glp-1-receptor-agonists-reminder-of-the-potential-side-effects-and-to-be-aware-of-the-potential-for-misuse2024-10-24T11:00:32+01:00GLP-1 receptor agonists: reminder of the potential side effects and to be aware of the potential for misuseHealthcare professionals are reminded to inform patients about the common and serious side effects associated with glucagon-like peptide-1 receptor agonists (GLP-1RAs). tag:www.gov.uk,2005:/drug-safety-update/insulin-pumps-and-continuous-glucose-monitoring-cgm-equipment-guidance-for-users-on-reporting-suspected-adverse-incidents-and-safety-concerns-to-the-mhras-yellow-card-scheme2024-10-24T11:00:27+01:00Insulin pumps and continuous glucose monitoring (CGM) equipment: guidance for users on reporting suspected adverse incidents and safety concerns to the MHRA’s Yellow Card schemeWe ask healthcare professionals to support new guidance for users of diabetes management equipment, their families, care givers and representatives.tag:www.gov.uk,2005:/drug-safety-update/bromocriptine-monitor-blood-pressure-when-prescribing-bromocriptine-for-prevention-or-inhibition-of-post-partum-physiological-lactation2024-10-24T11:00:18+01:00Bromocriptine: monitor blood pressure when prescribing bromocriptine for prevention or inhibition of post-partum physiological lactation A safety review has been conducted by the MHRA following a Yellow Card report concerning a patient who was taking bromocriptine. The review concluded that blood pressure monitoring of patients prescribed with this drug is es…tag:www.gov.uk,2005:/drug-safety-update/letters-and-medicine-recalls-sent-to-healthcare-professionals-in-september-20242024-10-24T11:00:11+01:00Letters and medicine recalls sent to healthcare professionals in September 2024 A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.tag:www.gov.uk,2005:/drug-safety-update/letters-and-medicine-recalls-sent-to-healthcare-professionals-in-august-20242024-09-26T15:00:38+01:00Letters and medicine recalls sent to healthcare professionals in August 2024 A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.tag:www.gov.uk,2005:/drug-safety-update/valproate-use-in-men-as-a-precaution-men-and-their-partners-should-use-effective-contraception2024-09-05T14:31:10+01:00Valproate use in men: as a precaution, men and their partners should use effective contraceptionA retrospective observational study has indicated a possible association between valproate use by men around the time of conception and an increased risk of neurodevelopmental disorders in their children.
Inform male p…tag:www.gov.uk,2005:/drug-safety-update/yellow-card-biobank-call-to-contribute-to-study-of-genetic-links-to-side-effects2024-08-21T11:00:45+01:00Yellow Card Biobank: call to contribute to study of genetic links to side effectsSupport this initiative to explore whether there is a genetic basis of side effects associated with direct-acting oral anticoagulants (DOACs) and allopurinol. tag:www.gov.uk,2005:/drug-safety-update/letters-and-medicine-recalls-sent-to-healthcare-professionals-in-july-20242024-08-21T11:00:39+01:00Letters and medicine recalls sent to healthcare professionals in July 2024 A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.tag:www.gov.uk,2005:/drug-safety-update/epimax-ointment-and-epimax-paraffin-free-ointment-reports-of-ocular-surface-toxicity-and-ocular-chemical-injury2024-07-23T14:01:13+01:00Epimax Ointment and Epimax Paraffin-Free Ointment: reports of ocular surface toxicity and ocular chemical injuryEpimax Ointment and Epimax Paraffin-Free Ointment can harm the eyes if used on the face. Do not prescribe these ointments for use on the face. Tell patients to wash their hands and avoid touching their eyes after using these…tag:www.gov.uk,2005:/drug-safety-update/letters-and-medicine-recalls-sent-to-healthcare-professionals-in-june-20242024-07-23T14:01:07+01:00Letters and medicine recalls sent to healthcare professionals in June 2024 A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices. tag:www.gov.uk,2005:/drug-safety-update/topiramate-topamax-introduction-of-new-safety-measures-including-a-pregnancy-prevention-programme2024-06-20T11:11:14+01:00Topiramate (Topamax): introduction of new safety measures, including a Pregnancy Prevention ProgrammeTopiramate is now contraindicated in pregnancy and in women of childbearing potential unless the conditions of a Pregnancy Prevention Programme are fulfilled. This follows a review by the MHRA which concluded that the use of…tag:www.gov.uk,2005:/drug-safety-update/warfarin-be-alert-to-the-risk-of-drug-interactions-with-tramadol2024-06-20T11:11:09+01:00Warfarin: be alert to the risk of drug interactions with tramadolTaking warfarin and tramadol together can cause harmful drug interactions, which can raise the International Normalised Ratio (INR), and result in severe bruising and bleeding, which in some patients could be fatal.tag:www.gov.uk,2005:/drug-safety-update/letters-and-medicine-recalls-sent-to-healthcare-professionals-in-may-20242024-06-20T11:11:05+01:00Letters and medicine recalls sent to healthcare professionals in May 2024A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.tag:www.gov.uk,2005:/drug-safety-update/topical-steroids-introduction-of-new-labelling-and-a-reminder-of-the-possibility-of-severe-side-effects-including-topical-steroid-withdrawal-reactions2024-05-29T14:32:45+01:00Topical steroids: introduction of new labelling and a reminder of the possibility of severe side effects, including Topical Steroid Withdrawal Reactions Topical steroid products are safe and highly effective treatments for the management of a wide range of inflammatory skin diseases but have important risks, especially with prolonged use at high potency. In the coming months…tag:www.gov.uk,2005:/drug-safety-update/letters-and-medicine-recalls-sent-to-healthcare-professionals-in-april-20242024-05-29T14:32:40+01:00Letters and medicine recalls sent to healthcare professionals in April 2024 A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices, and information about the publication of two recent Device Safety Information pages. The article also includ…tag:www.gov.uk,2005:/drug-safety-update/finasteride-reminder-of-the-risk-psychiatric-side-effects-and-of-sexual-side-effects-which-may-persist-after-discontinuation-of-treatment2024-04-29T16:03:17+01:00Finasteride: reminder of the risk psychiatric side effects and of sexual side effects (which may persist after discontinuation of treatment)A patient alert card is being introduced for men taking finasteride to help raise awareness of the risk of psychiatric side effects and sexual dysfunction, including the potential for sexual dysfunction to persist after trea…tag:www.gov.uk,2005:/drug-safety-update/montelukast-reminder-of-the-risk-of-neuropsychiatric-reactions2024-04-29T16:03:13+01:00Montelukast: reminder of the risk of neuropsychiatric reactionsHealthcare professionals prescribing montelukast should be alert to the risk of neuropsychiatric reactions in all patients including children and adolescents. Reported neuropsychiatric reactions include sleep disorders, hall…tag:www.gov.uk,2005:/drug-safety-update/letters-and-medicine-recalls-sent-to-healthcare-professionals-in-march-20242024-04-29T16:03:09+01:00Letters and medicine recalls sent to healthcare professionals in March 2024A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.tag:www.gov.uk,2005:/drug-safety-update/letters-and-medicine-recalls-sent-to-healthcare-professionals-in-february-20242024-03-27T11:53:02+00:00Letters and medicine recalls sent to healthcare professionals in February 2024A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.tag:www.gov.uk,2005:/drug-safety-update/codeine-linctus-codeine-oral-solutions-reclassification-to-prescription-only-medicine2024-02-20T11:01:38+00:00Codeine linctus (codeine oral solutions): reclassification to prescription-only medicineAdvice for healthcare professionals on the reclassification of codeine linctus to a prescription-only medicine (POM), following a public consultation. tag:www.gov.uk,2005:/drug-safety-update/pseudoephedrine-very-rare-risk-of-posterior-reversible-encephalopathy-syndrome-pres-and-reversible-cerebral-vasoconstriction-syndrome-rcvs2024-02-20T11:01:34+00:00Pseudoephedrine: very rare risk of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS)There have been very rare reports of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) with pseudoephedrine.