tag:www.gov.uk,2005:/drug-safety-updateDrug Safety Update about Neurology2025-12-04T14:00:32+00:00HM Governmenttag: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/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/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/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-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/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/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/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/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/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/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/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/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-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/valproate-re-analysis-of-study-on-risks-in-children-of-men-taking-valproate2023-08-30T10:31:12+01:00Valproate: re-analysis of study on risks in children of men taking valproate We are providing an update on a retrospective observational study on the risk to children born to men who took valproate in the 3 months before conception and on the need for the re-analysis of the data from this study befor…tag:www.gov.uk,2005:/drug-safety-update/letters-and-medicine-recalls-sent-to-healthcare-professionals-in-july-20232023-08-30T10:31:08+01:00Letters and medicine recalls sent to healthcare professionals in July 2023A summary of recent letters and notifications sent to healthcare professionals about medicines.tag:www.gov.uk,2005:/drug-safety-update/hyoscine-hydrobromide-patches-scopoderm-1-dot-5mg-patch-or-scopoderm-tts-patch-risk-of-anticholinergic-side-effects-including-hyperthermia2023-07-24T13:59:33+01:00Hyoscine hydrobromide patches (Scopoderm 1.5mg Patch or Scopoderm TTS Patch): risk of anticholinergic side effects, including hyperthermia There have been a small number of reports of serious and life-threatening anticholinergic side effects associated with hyoscine hydrobromide patches, particularly when used outside the licence. Healthcare professionals, pati…tag:www.gov.uk,2005:/drug-safety-update/letters-and-medicine-recalls-sent-to-healthcare-professionals-in-april-20232023-05-25T10:53:17+01:00Letters and medicine recalls sent to healthcare professionals in April 2023 Recent MHRA National Patient Safety Alerts to remove from service Philips Health Systems V60 and V60 Plus ventilators and to recall Emerade adrenaline auto-injectors from patients, pharmacies and wholesalers. We also provide…tag:www.gov.uk,2005:/drug-safety-update/valproate-reminder-of-current-pregnancy-prevention-programme-requirements-information-on-new-safety-measures-to-be-introduced-in-the-coming-months2022-12-12T12:00:31+00:00Valproate: reminder of current Pregnancy Prevention Programme requirements; information on new safety measures to be introduced in the coming monthsIn view of data showing ongoing exposure to valproate in pregnancy, this article reminds healthcare professionals of the risks in pregnancy and the current Pregnancy Prevention Programme requirements, and provides informatio…tag:www.gov.uk,2005:/drug-safety-update/methylphenidate-long-acting-modified-release-preparations-caution-if-switching-between-products-due-to-differences-in-formulations2022-09-26T16:19:41+01:00Methylphenidate long-acting (modified-release) preparations: caution if switching between products due to differences in formulationsPrescribers and dispensers should use caution if switching patients between different long-acting formulations of methylphenidate (Concerta XL, Medikinet XL, Equasym XL, Ritalin LA, and generics) as different instructions fo…tag:www.gov.uk,2005:/drug-safety-update/letters-and-medicine-recalls-sent-to-healthcare-professionals-in-august-20222022-09-26T16:19:15+01:00Letters and medicine recalls sent to healthcare professionals in August 2022A summary of recent letters and notifications sent to healthcare professionals about medicinestag:www.gov.uk,2005:/drug-safety-update/letters-and-medicine-recalls-sent-to-healthcare-professionals-in-july-20222022-08-23T11:04:18+01:00Letters and medicine recalls sent to healthcare professionals in July 2022A summary of recent letters and notifications sent to healthcare professionals about medicines, and a patient safety alert on mexiletine hydrochloride.tag:www.gov.uk,2005:/drug-safety-update/topiramate-topamax-start-of-safety-review-triggered-by-a-study-reporting-an-increased-risk-of-neurodevelopmental-disabilities-in-children-with-prenatal-exposure2022-07-21T11:03:55+01:00Topiramate (Topamax): start of safety review triggered by a study reporting an increased risk of neurodevelopmental disabilities in children with prenatal exposureWe have initiated a new safety review into topiramate as a result of an observational study reporting an increased risk of neurodevelopmental disabilities in children whose mothers took topiramate during pregnancy.
Topir…tag:www.gov.uk,2005:/drug-safety-update/letters-and-medicine-recalls-sent-to-healthcare-professionals-in-may-20222022-06-20T16:38:29+01:00Letters and medicine recalls sent to healthcare professionals in May 2022A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devicestag:www.gov.uk,2005:/drug-safety-update/pregabalin-lyrica-findings-of-safety-study-on-risks-during-pregnancy2022-04-19T14:27:52+01:00Pregabalin (Lyrica): findings of safety study on risks during pregnancyA new study has suggested pregabalin may slightly increase the risk of major congenital malformations if used in pregnancy. Patients should continue to use effective contraception during treatment and avoid use in pregnancy …tag:www.gov.uk,2005:/drug-safety-update/cladribine-mavenclad-new-advice-to-minimise-risk-of-serious-liver-injury2022-03-15T14:31:13+00:00Cladribine (Mavenclad): new advice to minimise risk of serious liver injuryLiver monitoring requirements for cladribine in the treatment of multiple sclerosis have been introduced following uncommon cases of serious liver injury. Advise patients to seek urgent medical attention if they develop any …tag:www.gov.uk,2005:/drug-safety-update/haloperidol-haldol-reminder-of-risks-when-used-in-elderly-patients-for-the-acute-treatment-of-delirium2021-12-10T11:01:51+00:00Haloperidol (Haldol): reminder of risks when used in elderly patients for the acute treatment of delirium We remind healthcare professionals that elderly patients are at an increased risk of adverse neurological and cardiac effects when being treated with haloperidol for delirium. The lowest possible dose of haloperidol should b…tag:www.gov.uk,2005:/drug-safety-update/letters-and-medicine-recalls-sent-to-healthcare-professionals-in-november-20212021-12-10T11:00:52+00:00Letters and medicine recalls sent to healthcare professionals in November 2021A summary of recent letters, medicine recalls and notifications sent to healthcare professionals.tag:www.gov.uk,2005:/drug-safety-update/chloral-hydrate-cloral-betaine-welldorm-restriction-of-paediatric-indication2021-10-06T12:25:45+01:00Chloral hydrate, cloral betaine (Welldorm): restriction of paediatric indication The paediatric indication for chloral hydrate (for children aged 2 years and older) and cloral (previously chloral) betaine (children aged 12 years and older) has been restricted to short-term treatment (maximum 2 weeks) of …tag:www.gov.uk,2005:/drug-safety-update/letters-and-medicine-recalls-sent-to-healthcare-professionals-in-august-20212021-09-15T10:37:43+01:00Letters and medicine recalls sent to healthcare professionals in August 2021A summary of recent letters, medicine recalls and notifications sent to healthcare professionalstag:www.gov.uk,2005:/drug-safety-update/letters-and-medicine-recalls-sent-to-healthcare-professionals-in-march-20212021-04-27T14:22:10+01:00Letters and medicine recalls sent to healthcare professionals in March 2021A summary of letters and recent medicine recalls and notifications sent to healthcare professionals.tag:www.gov.uk,2005:/drug-safety-update/letters-and-drug-alerts-sent-to-healthcare-professionals-in-february-20212021-03-24T14:27:38+00:00Letters and drug alerts sent to healthcare professionals in February 2021A summary of letters and drug alerts recently sent to healthcare professionals.tag:www.gov.uk,2005:/drug-safety-update/pregabalin-lyrica-reports-of-severe-respiratory-depression2021-02-18T11:36:41+00:00Pregabalin (Lyrica): reports of severe respiratory depressionPregabalin has been associated with infrequent reports of severe respiratory depression, including some cases without the presence of concomitant opioid medicines. Patients with compromised respiratory function, respiratory …tag:www.gov.uk,2005:/drug-safety-update/antiepileptic-drugs-in-pregnancy-updated-advice-following-comprehensive-safety-review2021-01-07T11:02:01+00:00Antiepileptic drugs in pregnancy: updated advice following comprehensive safety review A review of the risks of major congenital malformations and of adverse neurodevelopmental outcomes for antiepileptic drugs by the Commission on Human Medicines has confirmed that lamotrigine (Lamictal) and levetiracetam (Kep…tag:www.gov.uk,2005:/drug-safety-update/dimethyl-fumarate-tecfidera-updated-advice-on-the-risk-of-progressive-multifocal-leukoencephalopathy-pml-associated-with-mild-lymphopenia2021-01-07T11:01:04+00:00Dimethyl fumarate (Tecfidera): updated advice on the risk of progressive multifocal leukoencephalopathy (PML) associated with mild lymphopenia The monitoring requirements and discontinuation criteria for dimethyl fumarate (Tecfidera) have been strengthened following a small number of reports of progressive multifocal leukoencephalopathy (PML) in patients with mild …tag:www.gov.uk,2005:/drug-safety-update/fingolimod-gilenyav-updated-advice-about-the-risks-of-serious-liver-injury-and-herpes-meningoencephalitis2021-01-07T11:00:51+00:00Fingolimod (Gilenya▼): updated advice about the risks of serious liver injury and herpes meningoencephalitis Liver monitoring requirements and discontinuation criteria for fingolimod have been updated following reports of serious liver injury. Fatal cases of encephalitis and meningitis caused by herpes simplex and varicella zoster …tag:www.gov.uk,2005:/drug-safety-update/letters-and-drug-alerts-sent-to-healthcare-professionals-in-december-20202021-01-07T11:00:06+00:00Letters and drug alerts sent to healthcare professionals in December 2020A summary of letters and drug alerts recently sent to healthcare professionals.tag:www.gov.uk,2005:/drug-safety-update/letters-and-drug-alerts-sent-to-healthcare-professionals-in-november-20202020-12-17T17:08:25+00:00Letters and drug alerts sent to healthcare professionals in November 2020A summary of letters and drug alerts recently sent to healthcare professionals.
tag:www.gov.uk,2005:/drug-safety-update/modafinil-provigil-increased-risk-of-congenital-malformations-if-used-during-pregnancy2020-11-16T16:00:51+00:00Modafinil (Provigil): increased risk of congenital malformations if used during pregnancy Modafinil potentially increases the risk of congenital malformations when used in pregnancy. Modafinil should not be used during pregnancy and women of childbearing potential must use effective contraception during treatment…tag:www.gov.uk,2005:/drug-safety-update/letters-and-drug-alerts-sent-to-healthcare-professionals-in-september-20202020-10-22T14:14:36+01:00Letters and drug alerts sent to healthcare professionals in September 2020A summary of letters and drug alerts recently sent to healthcare professionals.tag:www.gov.uk,2005:/drug-safety-update/valproate-pregnancy-prevention-programme-temporary-advice-for-management-during-coronavirus-covid-192020-05-21T14:45:59+01:00 Valproate Pregnancy Prevention Programme: temporary advice for management during coronavirus (COVID-19)Guidance has been published to support initiation of valproate in female patients and for annual review and pregnancy testing during the coronavirus pandemic. tag:www.gov.uk,2005:/drug-safety-update/letters-and-drug-alerts-sent-to-healthcare-professionals-in-april-20202020-05-21T14:45:31+01:00Letters and drug alerts sent to healthcare professionals in April 2020A summary of letters and drug alerts recently sent to healthcare professionals.tag:www.gov.uk,2005:/drug-safety-update/letters-and-drug-alerts-sent-to-healthcare-professionals-in-march-20202020-04-27T15:59:03+01:00Letters and drug alerts sent to healthcare professionals in March 2020A summary of letters and drug alerts recently sent to healthcare professionals.