• Drug Safety Update on Nasal decongestant sprays and drops containing xylometazoline hydrochloride / oxymetazoline hydrochloride: increased risk of rebound congestion, rhinitis medicamentosa, and tachyphylaxis with overuse.
• Drug Safety Update on Finasteride and Dutasteride – updated safety warnings for psychiatric side effects and sexual dysfunction.
• Device safety Information on Kimal Procedure Packs containing recalled components: Namic Angiographic Syringe with the risk of syringe disconnection; Namic Manifolds with the risk of foreign particulates. Important guidance for use in urgent procedures where there are no alternatives.
• Device safety Information on Risk of severe harm from use of incorrect giving (administration) set for blood transfusion.
• Device safety Information on Allurion Gastric Balloon: Updated safety information due to the risks of gastric outlet obstruction, small bowel obstruction and gastric perforation.
• Letters, medicines recalls and device notifications sent to healthcare professionals in May 2026.
• News and guidance on:
• Dostarlimab (Jemperli) and immune-related skin adverse reactions: updates to the product information.
• BNF and BNFC updated guidance on medicines that cause drowsiness to help prevent co-sleeping deaths.

• Letters, medicines recalls and device notifications sent to healthcare professionals in April 2026.

News and guidance on:

• EMA recommends withdrawal of marketing authorisations for levamisole medicines following safety review.
• Publication of RSV vaccine factsheet.

• Drug Safety Update on Falsified Mounjaro KwikPen 15mg pre-filled pens 
• Drug Safety Update on Semaglutide (Wegovy, Ozempic and Rybelsus): risk of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) 
• Drug Safety Update on IXCHIQ Chikungunya vaccine: updates to restrictions of use following safety review 
• Drug Safety Update on GLP-1 receptor agonists and dual GLP-1/GIP receptor agonists: strengthened warnings on acute pancreatitis, including necrotising and fatal cases 
• Letters, medicines recalls and device notifications sent to healthcare professionals in February 2026  
• News and guidance on:
  • UKHSA and MHRA issue reminder to healthcare professionals regarding use of non-sterile alcohol-free wipes 
  • Updates to instructions for use (IFUs) of Cardinal Health Chest Drainage Units & accessories 
  • Respiratory tube connector: risk of patient harm due to manufacturing defect 
  • Medical devices regulations: targeted consultation on the indefinite recognition of CE marked devices 

• Drug Safety Update on Isotretinoin – changes to prescribing guidance and additional risk minimisation measures
• Drug Safety Update on Improving Information Supplied with Gabapentinoids (Pregabalin/Gabapentin), Benzodiazepines and Z-Drugs
• Device Safety Information on M6-C Artificial Cervical Disc, Spinal Kinetics LLC: New monitoring requirements for the risk of osteolysis (DSI/2026/001)
• Letters, medicines recalls and device notifications sent to healthcare professionals in January 2026
• News and guidance on:
  • Statins: update to product information on the role of the nocebo effect in muscle-related events.
  • Increased semaglutide dose for adults with obesity – prescribing advice.
  • Epimax Ointment and Epimax Paraffin-Free Ointment: reports of ocular surface toxicity and ocular chemical injury.
  • MMRV vaccine factsheet published.
  • New MHRA guidance for healthcare professionals and the public on the use of mental health apps and technologies.

• Letters, medicines recalls and device notifications sent to healthcare professionals in March 2026.

News and guidance on:

• Publication of meningitis factsheet .
• Patients to get new medicines up to six months sooner under new joint MHRA-NICE approval process.

• Gabapentinoids (pregabalin and gabapentin), benzodiazepines and z-drugs are three classes of medicines used to treat a variety of conditions such as neuropathic pain, anxiety and insomnia. Specialist use of these medications for conditions such as epilepsy, or sedation during medical procedures are not included in this review.
• All three classes of medications are known to pose risks of addiction, dependency, withdrawal and tolerance.
• The Summary of Product Characteristics, Patient Information Leaflets and Outer Packaging of these medicines will have strengthened warnings to better communicate the risks of addiction, dependency, withdrawal and tolerance to healthcare professionals and patients. Updates are in progress and will be rolled out over the coming months.
• Prior to starting treatment with these medicines, a discussion should be held with patients to put in place a strategy for reducing or ending treatment. By doing this the risk of addiction, dependence, and drug withdrawal syndrome is reduced. NICE guideline, NG215, has resources that include visual summaries which are available to support these discussions. The Agency has also developed additional patient resources for benzodiazepines, gabapentinoids and z-drugs which highlight key messages concerning these risks and should be made available to patients when these medications are prescribed.
• Addiction and dependence are related but have distinct presentations. Healthcare professionals are reminded of the importance of using non-judgmental language when discussing these terms.
• Patients may find that treatment is less effective with chronic use and express a need to increase the dose to obtain the same level of symptom control as initially experienced. This could be a sign that the patient is developing tolerance. The risks of developing tolerance should be explained to the patient.
• Drug withdrawal syndrome may occur upon abrupt cessation of therapy or dose reduction. When a patient no longer requires therapy, it is advisable to taper the dose gradually to reduce symptoms of withdrawal. Tapering from a high dose may take weeks or months. Patients should be informed of this when the medication is first prescribed and should be encouraged to speak to their healthcare professional or prescriber before stopping their medicine. See NICE guideline NG 215 for identifying and managing withdrawal symptoms.
• Provide regular support especially to individuals at increased risk of drug withdrawal syndrome, such as those with current or past history of substance use disorder (including alcohol misuse) or mental health disorder.
• Addiction, dependence, withdrawal or tolerance in response to these medications can be reported via the Yellow Card scheme

Advice for healthcare professionals to provide to patients:

• As these medicines carry risks of addiction, dependence and withdrawal reactions, before starting treatment with these medicines, your healthcare professional should explain how long you might need to take them for, and how to stop safely. This helps reduce the risk of addiction, dependence, and drug withdrawal syndrome.
• Anyone can become physically dependent on these medicines, meaning that their body gets used to it, and this can cause them to have withdrawal symptoms if the medicine is suddenly stopped, or the dose is reduced.
• Drug addiction can feel like a strong desire to take the medicine, and difficulties in controlling medicine use (for example feeling like you want to take more or use the medicine when you shouldn’t).
• Addiction and dependence are related but they are not the same, being physically dependent on a medicine does not necessarily mean you are addicted to it.
• Drug tolerance can mean no longer feeling like the medicine is working well, or feeling that a higher dose is required to achieve the same symptom relief as before.
• If you want to stop taking your medicine there are additional resources to help you. Never stop taking your medication without asking a healthcare professional first.
• If you are taking this medicine for epilepsy, you should keep taking it for as long as your doctor says it’s needed.
• If you find that your treatment is not working as well, you should speak to your healthcare professional about possible alternative treatment options, and you should never take more of your medicine than you have been prescribed.
• When it is time to stop your medication, your healthcare professional will tell you how to gradually reduce the amount of medicine you are taking over time (known as dose tapering). This is very important to reduce the risk of drug withdrawal syndrome. Dose tapering can sometimes take weeks or months. Mild symptoms may still occur, but you should contact your healthcare professional if the withdrawal symptoms become intolerable.

• Drug Safety Update on Mesalazine and idiopathic intracranial hypertension
• Drug Safety Update on Rybelsus ® (semaglutide tablets): transition to new formulation and risk of medication error
• Letters, medicines recalls and device notifications sent to healthcare professionals in December 2025
• News and guidance on:
  • Patient and family experiences inform antidepressant safety information review
  • Vaccine factsheet published
  • Call for evidence: Regulation of AI in Healthcare
  • MHRA updates guidance on the Health Institution Exemption to support safe use of medical devices
  • MHRA host workshop to improve Patient Information Leaflets

Who can take part

This Call for Evidence invites contributions from people and organisations across the UK and internationally. The information gathered will help inform the Commission’s recommendations and help address key challenges in regulating AI in healthcare.

Other opportunities such as workshops are also planned to hear directly from patients and members of the public.

Anyone can take part, but they especially want to hear from:

• Patients, the public, and charities
• AI health tech companies and industry groups
• NHS and independent healthcare leaders and health and care professionals
• Healthcare provider organisations and professional bodies
• UK and international healthcare regulators

Topics considered in the Call for Evidence

The Call for Evidence invites evidence and views on:

• whether the UK’s framework for regulating AI in healthcare is sufficient
• how the UK’s regulatory framework may need to be improved to ensure fast access to safe and effective AI medical devices
• approaches to checking safety once AI medical devices are in use
• how responsibility and liability are managed between different parties involved in the deployment of AI medical devices.

• Letters, medicines recalls and device notifications sent to healthcare professionals in November 2025 

News and guidance on:

• Reported Cases of Patient Deaths Among Duchenne Muscular Dystrophy Patients Receiving Duvyzat®▼ (givinostat) and reminder of risk mitigation measures 
• Tamoxifen: update to product information on QT prolongation and monitoring recommendations for high-risk patients 
• MHRA begins hosting Patient Safety Commissioner 

• Drug Safety Update on Isotretinoin – updates to prescribing guidance and survey of services.
• Device Safety Information on BD BodyComm™ version 3.3 software used for BodyGuard infusion pumps, BodyGuard-T and T34 syringe drivers: Important steps to manage transition to Windows 11.
• Drug Safety Update on #MedSafetyWeek (3-9 November 2025): A call to action to improve patient safety.
• Letters, medicines recalls and device notifications sent to healthcare professionals in October 2025. 

News and guidance on:

• Reminder of the risk of incorrect dosing when switching between different drug formulations
• Patient safety essay writing competition 2025 for medical students and foundation doctors now open 
• Side effects from drug interactions to be predicted by AI before reaching patients.

• Drug Safety Update on Paracetamol and pregnancy - reminder that taking paracetamol during pregnancy remains safe
• Device Safety Information on Profemur Cobalt Chrome Modular Neck Hip Replacements: Higher than anticipated risk of revision surgery, metal-wear effects and component fracture
• Letters, medicines recalls and device notifications sent to healthcare professionals in September 2025 
• News and guidance on:
• Nitrofurantoin: reminder of the risks of pulmonary and hepatic adverse drug reactions
• Trodelvy: Update to SmPC and reminder of risk of serious side effects
• Valproate prescribing report published
• MHRA reassures the public that taking paracetamol during pregnancy remains safe
• MHRA investigating unlicensed Botox products
• New Commission launched to accelerate NHS use of AI
• MHRA and partners unite to reaffirm prescription weight loss medicine advertising rules

• Letters, medicines recalls and device notifications sent to healthcare professionals in July and August 2025 
• News on:
• MHRA launches a Cosmetic Breast Augmentation Risk Awareness Tool.
• Specific brand of children’s magnesium gummies found to contain undeclared melatonin.
• Health Institution Exemption for medical devices – Stakeholder survey.
• Self-sampling at the point-of-care – enhancing access, improving care.

• Drug Safety Update on Abrysvo (Pfizer RSV vaccine) and Arexvy (GSK RSV vaccine): be alert to a small risk of Guillain-Barré syndrome following vaccination in older adults 
• Device Safety Information on Aurum pre-filled syringes - phased introduction of new 10ml CONNECT syringe barrel: Importance of selecting compatible needle-free connectors to minimise the risk of syringe blockage
• Device Safety Information on Trinity Biotech Premier Hb9210™ HbA1c Analyser: Risk of Positive Bias and Updates to Instructions for Use (IFU), including use as a diagnostic aid in diabetes mellitus
• Device Safety Information on Updated guidance on the management of the recalled Endologix Nellix EndoVascular Aneurysm Sealing System 
• Letters, medicines recalls and device notifications sent to healthcare professionals in June and July 2025 
• News on:
• Contamination of non-sterile alcohol-free skin cleansing wipes - actions for healthcare professionals
• Passy Muir speaking valve (PMV) - reminder of safe management after incident reports
• Yellow Card Biobank recruiting patients taking GLP-1’s and experiencing acute pancreatitis
• Publication of fluoroquinolone antibiotics Public Assessment Report (PAR)
• Launch of MHRA medical device survey – Have your say 

Whilst Ralstonia pickettii rarely causes an infection and the health risk to most people is very low, individuals with a weakened immune system are more likely to be affected. Those using the affected products should stop doing so and return them to their supplier or retailer.

These products have a wide range of uses within healthcare settings such as hospitals, but can also be used outside of healthcare organisations, for example as part of first aid kits purchased from shops.  

The brand names of the affected products are:

• Sodium Chloride Irrigation Solution 0.9 % w/v 20 ml (Blue Dot)
• Sodium Chloride Inhalation Solution 0.9 % w/v 2.5 ml
• Aerowash 20 ml Eyewash

Individuals and organisations can check if they have any of the affected batches listed in the company’s Field Safety Notice (FSN) by looking for the batch numbers on the product packaging. Any affected products should be returned promptly to their original place of purchase.   This will only affect products manufactured by Legency Remedies Pvt Ltd between April and November 2023.

If you  have been using a recalled product and have been feeling unwell, for example experiencing shaking or shivering and a raised temperature, you should inform a healthcare professional.

Retailers have been advised, where possible, to contact patients who have purchased any of the affected batches and ask them to return the product.

This new ‘roadmap’ for new regulations, from the Medicines and Healthcare products Regulatory Agency (MHRA), will enhance the UK’s ability to benefit from rapidly advancing medical technology, offering significant new opportunities for patients and healthcare.

Transformative technologies such as new implantable devices, healthcare AI and software, and diagnostics for early detection and prevention of disease, all demand a new regulatory framework.

The MHRA’s roadmap sets out a route to deliver enabling regulation via a series of new Statutory Instruments (SIs). Priority measures to protect patient safety will be put in place this year, with core elements of the new framework intended to be in place by 2025.

The planned regulations are also designed to deliver greater international harmonisation, with more patient-centred, proportionate requirements for medical devices which are responsive to technological advances.

• Systemic (by mouth, injection, or inhalation) fluoroquinolones can cause long-lasting (up to months or years), disabling, and potentially irreversible side effects, sometimes affecting multiple systems, organ classes, and senses
• Despite new restrictions and precautions introduced in 2019, a new study has shown no evidence of a change in fluoroquinolone prescribing patterns in the UK, and the MHRA has continued to receive Yellow Card reports of these side effects.
• Advise patients to stop treatment at the first signs of a serious adverse reaction, such as tendinitis or tendon rupture, muscle pain, muscle weakness, joint pain, joint swelling, peripheral neuropathy, and central nervous system effects, and to contact their doctor immediately for further advice.
• Do not prescribe fluoroquinolones:
• for non-severe or self-limiting infections, or non-bacterial conditions, for example non-bacterial (chronic) prostatitis.
• for mild to moderate infections (such as in acute exacerbation of chronic bronchitis and chronic obstructive pulmonary disease).unless other antibiotics that are commonly recommended for these infections are consider inappropriate (see below)
• Do not prescribe ciprofloxacin or levofloxacin for uncomplicated cystitis unless other antibiotics that are commonly recommended are considered inappropriate (see below).
• Avoid fluoroquinolone use in patients who have previously had serious adverse reactions with a quinolone antibiotic (for example, nalidixic acid) or a fluoroquinolone antibiotic
• Prescribe fluoroquinolones with special caution for people older than 60 years and for those with renal impairment or solid-organ transplants, because they are at a higher risk of tendon injury
• Avoid use of a corticosteroid with a fluoroquinolone since coadministration could exacerbate fluoroquinolone-induced tendinitis and tendon rupture
• Report suspected adverse drug reactions to fluoroquinolone antibiotics on the Yellow Card website or via the Yellow Card app (download it from the Apple App Store, or Google Play Store

Advice for healthcare professionals to give to patients and caregivers:

• Fluoroquinolone antibiotics are a group of antibiotics that include ciprofloxacin, delafloxacin, levofloxacin, moxifloxacin, and ofloxacin – sometimes these medicines may also have a brand name so patients should check the details of all antibiotics prescribed to them.
• Fluoroquinolone antibiotics have been reported to cause serious side effects involving tendons, muscles, joints, nerves, or mental health – in some patients, these side effects have caused long-lasting or permanent disability.
• Stop taking your fluoroquinolone antibiotic and contact your doctor immediately if you have any of the following signs of a side effect:
• tendon pain or swelling – if this happens, rest the painful area until you can see your doctor
• pain in your joints or swelling in your shoulders, arms, or legs
• abnormal pain or sensations (such as persistent pins and needles, tingling, tickling, numbness, or burning), weakness in your body, especially in the legs or arms, or difficulty walking
• severe tiredness, depressed mood, anxiety, or problems with your memory or severe problems sleeping
• changes in your vision, taste, smell, or hearing
• tell your doctor if you have had any of the above effects during or shortly after taking a fluoroquinolone – this means you should avoid them in the future.