Drug Safety Update

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Finasteride and Dutasteride 鈥� updated safety warnings for psychiatric side effects and sexual dysfunction

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.
- Therapeutic area: Dermatology and 7 others
- Published: 11 May 2026
Nasal 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.
- Therapeutic area: Dispensing GP practices and 5 others
- Published: 30 April 2026
Falsified 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鈥�
- Therapeutic area: Dispensing GP practices and 5 others
- Published: 24 February 2026
Semaglutide (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鈥�
- Therapeutic area: Emergency medicine and 5 others
- Published: 5 February 2026
GLP-1 receptor agonists and dual GLP-1/GIP receptor agonists: strengthened warnings on acute pancreatitis, including necrotising and fatal cases

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鈥�
- Therapeutic area: Emergency medicine and 5 others
- Published: 29 January 2026
Isotretinoin 鈥� changes to prescribing guidance and additional risk minimisation measures

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鈥�
- Therapeutic area: Dermatology and 4 others
- Published: 22 January 2026
Improving Information Supplied with Gabapentinoids (Pregabalin/Gabapentin), Benzodiazepines and Z-Drugs

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鈥�
- Therapeutic area: General practice and 2 others
- Published: 8 January 2026
Rybelsus 庐 (semaglutide tablets): transition to new formulation and risk of medication error

There is a risk of patient harm arising through medication error during a transition period where the original and new formulation of Rybelsus 庐 tablets, which have different stated mg doses but are bioequivalent, will both 鈥�
- Therapeutic area: Care home staff and 6 others
- Published: 17 December 2025
Mesalazine and idiopathic intracranial hypertension

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鈥�
- Therapeutic area: Emergency medicine and 4 others
- Published: 4 December 2025
Isotretinoin 鈥� updates to prescribing guidance and survey of services

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鈥�
- Therapeutic area: Dermatology and 4 others
- Published: 27 October 2025
#MedSafetyWeek (3-9 November 2025): A call to action to improve patient safety

The annual #MedSafetyWeek campaign takes place from 3 to 9 November 2025. This year鈥檚 campaign theme is 鈥榳e can all help make medicines safer.鈥�
- Therapeutic area: Anaesthesia and intensive care and 39 others
- Published: 23 October 2025
Paracetamol and pregnancy - reminder that taking paracetamol during pregnancy remains safe

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鈥�
- Therapeutic area: Anaesthesia and intensive care and 34 others
- Published: 23 September 2025
Abrysvo鈻� (Pfizer RSV vaccine) and Arexvy鈻� (GSK RSV vaccine): be alert to a small risk of Guillain-Barr茅 syndrome following vaccination in older adults

There is a small increase in the risk of Guillain-Barr茅 syndrome following vaccination with Abrysvo (Pfizer respiratory syncytial virus (RSV) vaccine) and Arexvy (GSK RSV vaccine) in adults aged 60 years and older. Healthca鈥�
- Therapeutic area: Anaesthesia and intensive care and 5 others
- Published: 7 July 2025
Valproate (Belvo, Convulex, Depakote, Dyzantil, Epilim, Epilim Chrono or Chronosphere, Episenta, Epival, and Syonell鈻�): updated safety and educational materials to support patient discussion on reproductive risks

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鈥�
- Therapeutic area: General practice and 5 others
- Published: 10 June 2025
Kaftrio鈻� (Ivacaftor, tezacaftor, elexacaftor): risk of psychological side effects

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鈥�
- Therapeutic area: General practice and 2 others
- Published: 7 May 2025
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

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鈥�
- Therapeutic area: General practice and 2 others
- Published: 24 April 2025
Fezolinetant鈻�(Veoza): risk of liver injury; new recommendations to minimise risk

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鈥�
- Therapeutic area: Dispensing GP practices and 2 others
- Published: 10 April 2025

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