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Contraindicated in patients with any known current cancer
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A summary of letters sent to healthcare professionals, including an important reminder about the withdrawal of retigabine (Trobalt) from the market.
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Healthcare professionals should not prescribe them to newly diagnosed patients as first-line treatment, except for those with severe hypertriglyceridaemia or those who cannot take statins.
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Concerns over recent years about the use of antipsychotics to treat the behavioural and psychological symptoms of dementia (BPSD).
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A case of progressive multifocal leukoencephalopathy (PML) with a fatal outcome was reported in a patient with rheumatoid arthritis who had not previously received treatment with methotrexate or a TNF antagonist.
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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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Licensed doses and differences in potency between different inhaled corticosteroids; advice for use with spacer device.
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A summary of letters sent to healthcare professionals in September 2016, including important information for professionals who specialise in epilepsy treatment regarding the withdrawal from the market of retigabine (Trobalt).
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Risk of intraocular lens opacification.
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Risk of extrapyramidal effects or withdrawal symptoms (or both) in newborns after maternal use of antipsychotics during the third trimester of pregnancy.
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The design and content of the Patient Information Leaflets for methylphenidate products are being updated with the latest guidance on safe and effective use for patients and carers
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Screening for hepatitis B virus is now recommended in all patients (not only those at risk of this infection) before starting treatment for all indications.
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Recent information relating to COVID-19 vaccines and medicines that has been published since the December 2021 issue of Drug Safety Update, up to 13 January 2022.
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Healthcare professionals should be aware that these capsules contain potential allergens.
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Sildenafil is not authorised for use in pregnancy for the treatment of intrauterine growth restriction. The STRIDER clinical trial, which was studying the use of sildenafil in pregnancy for intrauterine growth restriction, h…
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In 2008 MHRA commissioned Ipsos MORI to research the public’s perception of herbal medicines, the findings may help doctors and pharmacists when considering how to advise patients.
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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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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices. Includes a recent recall of Accupro (quinapril hydrochloride) and advice on Xagrid (anagrelide hydrochloride…
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The authorisation holder for dapagliflozin has withdrawn the indication for type 1 diabetes mellitus. The removal of the type 1 diabetes indication is not due to any new safety concerns and the other indications of dapaglifl…
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Rarely, severe adverse effects can occur on stopping treatment with topical corticosteroids, often after long-term continuous or inappropriate use of moderate to high potency products. To reduce the risks of these events, pr…
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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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Letters were sent about Cetrotide (cetrorelix acetate), Eperzan▼(albiglutide), darunavir/cobicistat, Keytruda▼ (pembrolizumab), Denzapine (clozapine) 50 mg/mL oral suspension, and Bleo-Kyowa (bleomycin sulphate).
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Alerts were issued about Arrow EZ-IO intraosseous vascular access needle sets, Medicina IV Luer Slip syringes, and Spectra Optia apheresis systems.
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Recall will begin in September 2011 to allow sufficient time for patients to be switched to suitable alternatives.
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In light of feedback, we have clarified our article on concomitant use of these medicines in heart failure.
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Alerts were issued about Telefunken automated external defibrillators and BD Microtainer capillary blood specimen collection tubes.
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Batches of this medicine are being recalled from the market because of low levels of microbial contamination.
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We continue to receive a substantial number of serious and fatal adverse event reports for warfarin through our Yellow Card Scheme.
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Patients who use products that contain maltose, xylose, or galactose should use glucose-specific monitors.
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A European review has begun into the safety of radium-223 dichloride following an observed increase in the incidence of deaths and fractures in patients with chemotherapy-naive metastatic castration-resistant prostate cancer…
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Ongoing patient survey data suggest that more effort is needed by clinicians to achieve full and timely compliance with the valproate Pregnancy Prevention Programme and meet the goal to rapidly reduce and eventually eliminat…
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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…
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Alerts were issued about ConvaTec Suction catheters, gastro-enteral tubes, intermittent urology catheters and sterile urine drainage bags, CME T34 ambulatory syringe pumps, and HeartStart MRx monitor/defibrillators.
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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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Updated guidance on minimising risk of life-threatening and fatal air embolism.
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A European review has considered MHRA evidence together with additional information from spontaneous reporting and published literature.
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Emergency contraceptives remain suitable for all women regardless of the woman’s weight or body mass index (BMI).
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Recent information relating to COVID-19 vaccines and medicines that has been published since the March 2022 issue of Drug Safety Update, up to 14 April 2022.
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Alerts were issued about FreeStyle Libre flash glucose sensors and Arjo Minstrel passive floor lifts (portable hoist).
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Calcium salts (either calcium chloride or calcium gluconate) are used to stabilise the myocardium and prevent cardiac arrest in patients experiencing severe hyperkalaemia. However, the two salts are not equivalent in terms o…
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Advise patients taking hydrochlorothiazide-containing products of the cumulative, dose-dependent risk of non-melanoma skin cancer, particularly in long-term use, and the need to regularly check for (and report) any suspiciou…
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Nicorandil is associated with a risk of gastrointestinal ulceration including perianal ulceration.
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Restricted dose and duration of use.
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Aceclofenac is now contraindicated in patients with certain established cardiovascular diseases.
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Erythema multiforme, Stevens Johnson syndrome and toxic epidermal necrolysis reported in association with isotretinoin - may result in hospitalisation, disability, life-threatening events, or death.
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Healthcare professionals should be aware of this risk when prescribing prasugrel.
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A supply disruption alert was issued by the Department of Health & Social Care (DHSC) on EpiPen and EpiPen Junior; see MHRA advice on extension of use beyond the expiry date for certain batches of EpiPen 300 microgram ad…
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If a patient reports persistent symptoms when switching between different levothyroxine tablet formulations, consider consistently prescribing a specific product known to be well tolerated by the patient. If symptoms or poor…
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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices
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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.