tag:www.gov.uk,2005:/drug-safety-update 2026-05-11T14:29:47+01:00 HM Government tag:www.gov.uk,2005:/drug-safety-update/finasteride-and-dutasteride-updated-safety-warnings-for-psychiatric-side-effects-and-sexual-dysfunction 2026-05-11T14:29:47+01:00

The 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-overuse 2026-04-30T14:01:45+01:00

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-pens 2026-02-24T14:00:08+00:00

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/semaglutide-wegovy-ozempic-and-rybelsus-risk-of-non-arteritic-anterior-ischemic-optic-neuropathy-naion 2026-02-05T13:24:42+00:00

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-cases 2026-01-29T14:07:50+00:00

The 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-measures 2026-01-22T16:15:32+00:00

The 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-drugs 2026-01-08T11:01:39+00:00

The 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-error 2025-12-17T14:17:47+00:00

There 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-hypertension 2025-12-04T14:00:32+00:00

Idiopathic 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-services 2025-10-27T11:00:14+00:00

The 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-safety 2025-10-23T14:00:13+01:00

The 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-safe 2025-09-23T17:41:18+01:00

Patients 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-adults 2025-07-07T13:29:13+01:00

There 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-risks 2025-06-10T12:02:24+01:00

Updated 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/kaftriov-ivacaftor-tezacaftor-elexacaftor-risk-of-psychological-side-effects 2025-05-07T13:59:47+01:00

Psychological 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-guidelines 2025-04-24T12:02:48+01:00

Healthcare 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-risk 2025-04-10T12:00:08+01:00

Fezolinetant 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…