tag:www.gov.uk,2005:/drug-safety-updateDrug Safety Update2025-03-12T11:02:10+00:00HM Governmenttag: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. tag:www.gov.uk,2005:/drug-safety-update/letters-and-medicine-recalls-sent-to-healthcare-professionals-in-january-20242024-02-20T11:01:30+00:00Letters and medicine recalls sent to healthcare professionals in January 2024A 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-new-safety-and-educational-materials-to-support-regulatory-measures-in-men-and-women-under-55-years-of-age2024-01-22T15:41:20+00:00Valproate (Belvo, Convulex, Depakote, Dyzantil, Epilim, Epilim Chrono or Chronosphere, Episenta, Epival, and Syonell�): new safety and educational materials to support regulatory measures in men and women under 55 years of ageNew safety and educational materials have been introduced for men and women and healthcare professionals to reduce the harms from valproate, including the significant risk of serious harm to the baby if taken during pregnanc�tag:www.gov.uk,2005:/drug-safety-update/fluoroquinolone-antibiotics-must-now-only-be-prescribed-when-other-commonly-recommended-antibiotics-are-inappropriate2024-01-22T15:41:07+00:00Fluoroquinolone antibiotics: must now only be prescribed when other commonly recommended antibiotics are inappropriateSystemic fluoroquinolones must now only be prescribed when other commonly recommended antibiotics are inappropriate. This follows a review by the MHRA which looked at the effectiveness of current measures to reduce the ident�tag:www.gov.uk,2005:/drug-safety-update/omega-3-acid-ethyl-ester-medicines-omacor-slash-teromeg-1000mg-capsules-dose-dependent-increased-risk-of-atrial-fibrillation-in-patients-with-established-cardiovascular-diseases-or-cardiovascular-risk-factors2024-01-22T15:40:54+00:00Omega-3-acid ethyl ester medicines (Omacor/Teromeg 1000mg capsules): dose-dependent increased risk of atrial fibrillation in patients with established cardiovascular diseases or cardiovascular risk factorsSystematic reviews and meta-analyses of randomised controlled trials have highlighted a dose-dependent increased risk of atrial fibrillation in patients with established cardiovascular diseases or cardiovascular risk factors�tag:www.gov.uk,2005:/drug-safety-update/letters-and-medicine-recalls-sent-to-healthcare-professionals-in-december-20232024-01-22T15:40:41+00:00Letters and medicine recalls sent to healthcare professionals in December 2023A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices. tag:www.gov.uk,2005:/drug-safety-update/aripiprazole-abilify-and-generic-brands-risk-of-pathological-gambling2023-12-18T14:51:18+00:00Aripiprazole (Abilify and generic brands): risk of pathological gambling Healthcare professionals prescribing aripiprazole are reminded to be alert to the risk of addictive gambling and other impulse control disorders. Healthcare professionals should advise patients, their families and friends to�tag:www.gov.uk,2005:/drug-safety-update/vitamin-b12-hydroxocobalamin-cyanocobalamin-advise-patients-with-known-cobalt-allergy-to-be-vigilant-for-sensitivity-reactions2023-12-18T14:51:12+00:00Vitamin B12 (hydroxocobalamin, cyanocobalamin): advise patients with known cobalt allergy to be vigilant for sensitivity reactions The medicines used to treat vitamin B12 deficiency (hydroxocobalamin, cyanocobalamin) contain cobalt. There are case reports in the literature describing cobalt sensitivity-type reactions in patients being treated for vitami�tag:www.gov.uk,2005:/drug-safety-update/letters-and-medicine-recalls-sent-to-healthcare-professionals-in-november-20232023-12-18T14:51:06+00:00Letters and medicine recalls sent to healthcare professionals in November 2023 A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices, and a recent National Patient Safety Alert asking organisations to put a plan in place to implement new regu�tag:www.gov.uk,2005:/drug-safety-update/ozempicv-semaglutide-and-saxenda-liraglutide-vigilance-required-due-to-potentially-harmful-falsified-products2023-11-23T14:15:41+00:00Ozempic�(semaglutide) and Saxenda (liraglutide): vigilance required due to potentially harmful falsified products Falsified, potentially harmful Ozempic� and Saxenda products have been found in the UK. tag:www.gov.uk,2005:/drug-safety-update/nirmatrelvir-ritonavir-paxlovidv-be-alert-to-the-risk-of-drug-interactions-with-ritonavir2023-11-23T14:15:36+00:00Nirmatrelvir, ritonavir (Paxlovid�): be alert to the risk of drug interactions with ritonavir There is a risk of harmful drug interactions with the ritonavir component of the COVID-19 treatment Paxlovid� due to its inhibition of the enzyme CYP3A, which metabolises many commonly used drugs. Prescribers should obtain a�tag:www.gov.uk,2005:/drug-safety-update/e-cigarette-use-or-vaping-reminder-to-remain-vigilant-for-suspected-adverse-reactions-and-safety-concerns-and-report-them-to-the-yellow-card-scheme2023-11-23T14:15:31+00:00E-cigarette use or vaping: reminder to remain vigilant for suspected adverse reactions and safety concerns and report them to the Yellow Card scheme Healthcare professionals should be vigilant for suspected adverse reactions and safety concerns associated with e-cigarettes and e-liquids, commonly known as vapes. Please report adverse reactions to the Yellow Card scheme a�tag:www.gov.uk,2005:/drug-safety-update/letters-and-medicine-recalls-sent-to-healthcare-professionals-in-october-20232023-11-23T14:15:26+00:00 Letters and medicine recalls sent to healthcare professionals in October 2023A summary of recent letters and notifications sent to healthcare professionals about medicines.tag:www.gov.uk,2005:/drug-safety-update/isotretinoin-roaccutanev-introduction-of-new-safety-measures-including-additional-oversight-of-the-initiation-of-treatment-for-patients-under-18-years-of-age2023-10-31T10:29:28+00:00Isotretinoin (Roaccutane�): introduction of new safety measures, including additional oversight of the initiation of treatment for patients under 18 years of ageWe have strengthened the safe use of isotretinoin through the introduction of additional oversight of the initiation of isotretinoin in patients under 18 years and through improved assessment and monitoring of mental health �tag:www.gov.uk,2005:/drug-safety-update/medsafetyweek-november-2023-your-yellow-card-report-helps-to-improve-patient-safety2023-10-31T10:29:22+00:00MedSafetyWeek November 2023: your Yellow Card report helps to improve patient safetyThe eighth annual #MedSafetyWeek social media campaign will take place from 6 to 12 November 2023. It will focus on the importance of reporting suspected adverse reactions to medicines and suspected problems with medical dev�tag:www.gov.uk,2005:/drug-safety-update/valproate-dispense-full-packs-of-valproate-containing-medicines2023-10-31T10:29:15+00:00Valproate: dispense full packs of valproate-containing medicinesUnless there are exceptional circumstances, valproate-containing medicines must always be dispensed in the manufacturer’s original full pack. tag:www.gov.uk,2005:/drug-safety-update/letters-and-medicine-recalls-sent-to-healthcare-professionals-in-september-20232023-10-31T10:29:09+00:00Letters and medicine recalls sent to healthcare professionals in September 2023A 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. tag:www.gov.uk,2005:/drug-safety-update/statins-very-infrequent-reports-of-myasthenia-gravis2023-09-26T14:30:33+01:00Statins: very infrequent reports of myasthenia gravis Globally, there has been a very small number of reports of new-onset or aggravation of pre-existing myasthenia gravis with atorvastatin, pravastatin, lovastatin, fluvastatin, simvastatin, rosuvastatin and pitavastatin (singl�tag:www.gov.uk,2005:/drug-safety-update/fluoroquinolone-antibiotics-suicidal-thoughts-and-behaviour2023-09-26T14:30:19+01:00Fluoroquinolone antibiotics: suicidal thoughts and behaviourHealthcare professionals prescribing fluoroquinolone antibiotics (ciprofloxacin, delafloxacin, levofloxacin, moxifloxacin, ofloxacin) are reminded to be alert to the risk of psychiatric reactions, including depression and ps�tag:www.gov.uk,2005:/drug-safety-update/letters-and-medicine-recalls-sent-to-healthcare-professionals-in-august-20232023-09-26T14:30:07+01:00Letters and medicine recalls sent to healthcare professionals in August 2023A summary of recent letters and notifications sent to healthcare professionals about medicines, and a recent National Patient Safety Alert highlighting the risk of deaths and serious injuries from entrapment or falls relatin�tag:www.gov.uk,2005:/drug-safety-update/fluoroquinolone-antibiotics-reminder-of-the-risk-of-disabling-and-potentially-long-lasting-or-irreversible-side-effects2023-08-30T10:48:23+01:00Fluoroquinolone antibiotics: reminder of the risk of disabling and potentially long-lasting or irreversible side effectsHealthcare professionals prescribing fluoroquinolone antibiotics (ciprofloxacin, delafloxacin, levofloxacin, moxifloxacin, ofloxacin) are reminded to be alert to the risk of disabling and potentially long-lasting or irrevers�tag:www.gov.uk,2005:/drug-safety-update/methotrexate-advise-patients-to-take-precautions-in-the-sun-to-avoid-photosensitivity-reactions2023-08-30T10:31:17+01:00Methotrexate: advise patients to take precautions in the sun to avoid photosensitivity reactionsPhotosensitivity reactions are known side effects of methotrexate treatment and can be severe. Patients should be advised to take precautions to protect their skin in the sun.