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New specific guidance on dose-dependent prolongation of QTc with ondansetron.
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If Fournier’s gangrene is suspected, stop the SGLT2 inhibitor and start treatment urgently (including antibiotics and surgical debridement). Fournier’s gangrene is a rare but potentially life-threatening infection that requi…
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Liver function tests should be carried out at treatment initiation, during treatment, and also when the dose is increased.
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A summary of letters and recent medicine recalls and notifications sent to healthcare professionals.
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Check full blood counts before prescribing dimethyl fumarate and then every 6 to 12 months. Stop treatment immediately if you suspect progressive multifocal leukoencephalopathy.
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We are running a second social media campaign to promote the reporting of suspected adverse drug reactions (ADRs) to the Yellow Card Scheme in support of the ADR awareness week taking place 20-24 November 2017. The main mess…
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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
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New contraindications, warnings, and advice for monitoring.
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The European Medicines Agency (EMA) has recommended the immediate suspension of the marketing authorisation and recall of daclizumab (Zinbryta) in the EU following reports of serious inflammatory brain disorders, including e…
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New maximum daily dose restrictions (including in elderly patients), contraindications, and warnings.
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Addition of a polyethylene glycol (PEG)-based laxative to a liquid that has been thickened with a starch-based thickener may counteract the thickening action, placing patients with dysphagia at a greater risk of aspiration.
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MHRA has received reports of unintentional overdose of fentanyl due to dosing errors, accidental exposure, and exposure of the patch to a heat source.
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We ask healthcare professionals to support new guidance for users of diabetes management equipment, their families, care givers and representatives.
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Use has been restricted to 48 hours’ maximum parenteral use under specialist supervision, after a European safety review.
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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.
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Healthcare professionals should consider the possibility of second primary malignancy in patients treated with lenalidomide.
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Updated advice for healthcare professionals is available, after conclusion of a review of the safety of idelalisib, including the risk of infection.
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Increased risk of stroke in older women should be taken into account in prescribing decisions.
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SGLT2 inhibitor treatment should be interrupted in patients who are hospitalised for major surgical procedures or acute serious medical illnesses and ketone levels measured, preferably in blood rather than urine. Treatment m…
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A 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 …
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Monitoring of blood electrolytes is essential in patients coprescribed a potassium-sparing diuretic and an angiotensin converting enzyme inhibitor (ACEi) or an angiotensin receptor blocker (ARB) for heart failure.
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The 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…
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Monitor glucose levels closely in patients with diabetes during direct-acting antiviral therapy for hepatitis C, particularly within the first 3 months of treatment, and modify diabetes medication or doses when necessary. Pa…
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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 …
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Recent epidemiological studies suggest exposure to ondansetron during the first trimester of pregnancy is associated with a small increased risk of the baby having a cleft lip and/or cleft palate.
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Use of a nebuliser purchased independently of medical advice for use in the home to deliver nebulised asthma rescue medications to children can mask a deterioration in the underlying disease and may increase the risk of pote…
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The seventh annual #MedSafetyWeek social media campaign will take place 7 to 13 November 2022 and this year’s focus is the importance of reporting suspected adverse reactions to medicines and vaccines. We are also encouragin…
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Do not prescribe etoricoxib to patients whose blood pressure is persistently above 140/90 mmHg and inadequately controlled.
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It is recommended that 2 adrenaline auto-injectors are prescribed, which patients should carry at all times.
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Cutaneous amyloidosis at the injection site has been reported in patients using insulin and this may affect glycaemic control. Remind patients to rotate injection sites within the same body region.
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Systemic 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…
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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…
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Our sixth annual #MedSafetyWeek social media campaign will take place on 1 to 7 November 2021. This year’s theme is on the importance of reporting suspected adverse reactions to vaccines.
Show your support by sharing MHRA …
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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…
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There is an increased risk of myopathy associated with high-dose (80 mg) simvastatin.…
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We have introduced pack size restrictions, revised recommended ages for use, and new safety warnings for over-the-counter stimulant laxatives (orally and rectally administered) following a national safety review. Advise pati…
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Cases of severe cutaneous adverse reactions, including Stevens-Johnsons syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in patients treated with immune-stimulatory anti-cancer drugs, including atezoli…
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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.
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Periodically perform skin examinations in patients on bendamustine-containing regimens and consider PML in the differential diagnosis for patients on bendamustine with new or worsening neurological, cognitive, or behavioural…
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Patients with existing meningioma or a history of meningioma must not be prescribed high-dose (≥25 mg per day) cyproterone acetate.
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Carefully consider the benefits and risks before prescribing systemic azithromycin or other systemic macrolide antibiotics (erythromycin or clarithromycin) to patients being treated with hydroxychloroquine or chloroquine. An…
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The ninth annual #MedSafetyWeek social media campaign is taking place 4 to 10 November 2024.
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The indication of ulipristal acetate 5mg for uterine fibroids has been further restricted due to the risk of serious liver injury and liver failure, with some cases requiring liver transplantation. Although the temporary sus…
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Emerade 300 and 500 microgram adrenaline auto-injectors have been re-supplied to the market following the implementation of corrective actions – patients and their caregivers should be provided with training and advice speci…
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Be especially alert for adverse drug reactions (ADRs) in patients taking more than one medicine and report any suspected ADRs to the Yellow Card Scheme. Show your support for the MHRA’s ADR awareness week campaign on 17–23 F…
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Several new high strength insulin products are now on the market. The European Medicines Agency is consulting on guidance to minimise the risk of medication error.
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There have been reports of cardiac events including QT prolongation, torsades de pointes, and cardiac arrest in patients who have taken high or very high doses of loperamide as a drug of abuse or for self-treatment of opioid withdrawal.…
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NHS Evidence Accreditation Scheme recognises organisations that demonstrate high standards in producing health or social care guidance.
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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.…
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…High-risk gadolinium-containing contrast agents are contraindicated in patients with severe renal impairment, patients in the perioperative liver-transplantation period, and in neonates