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SSRIs and SNRIs are known to increase bleeding risks due to their effect on platelet function. Data from observational studies suggest that the use of SSRI/SNRI antidepressants during the month before delivery may result in …
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Rivaroxaban treatment in patients who undergo transcatheter aortic valve replacement (TAVR) should be stopped and switched to standard of care.
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Coadministration of a corticosteroid with an HIV-treatment-boosting agent may increase the risk of adrenal suppression due to a pharmacokinetic interaction.
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Reminder to monitor and manage weight, glucose, and lipid levels.
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A summary of letters and drug alerts recently sent to healthcare professionals.
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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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New data have confirmed that the risk of breast cancer is increased during use of all types of HRT, except vaginal estrogens, and have also shown that an excess risk of breast cancer persists for longer after stopping HRT th…
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Five cases of necrotising fasciitis have been reported in patients treated with panitumumab in combination with chemotherapy.
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Letters were sent about Myocrisin (sodium aurothiomalate), Cerliponase alfa (Brineura▼), Darzalex▼(daratumumab), retinoids▼, and febuxostat (Adenuric). A recall alert was issued for medicines that were taken out of the regul…
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Diabetic ketoacidosis has been reported in patients with type 2 diabetes on a combination of a GLP-1 receptor agonist and insulin who had doses of concomitant insulin rapidly reduced or discontinued. GLP-1 receptor agonists …
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Further evidence that the cardiovascular risk with diclofenac is higher than other non-selective NSAIDs and similar to the selective COX-2 inhibitors.
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New reports of serious hypersensitivity reactions (including anaphylaxis) in patients receiving panitumumab, some of which were fatal.
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In light of the most recent evidence, the previous advice on the concomitant use of clopidogrel with proton pump inhibitors has now been modified. Use of either omeprazole or esomeprazole with clopidogrel should be discourag…
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Where possible, use an appropriate alternative therapy for patients at increased risk of thrombosis.
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New safety information for intensive monitoring of Erlotinib.
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Amended advice on the insertion site for Nexplanon contraceptive implants following concerns regarding reports of neurovascular injury and implants migrating to the vasculature (including the pulmonary artery).
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As the safety of COVID-19 antivirals in pregnancy has not been established, please report any pregnancies which occur during use of an antiviral, including paternal use, to the UK COVID-19 Antivirals Pregnancy Registry. This…
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With the exception of medicines containing zidovudine, stavudine, or didanosine, product information will no longer include warnings on fat redistribution or lactic acidosis.
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We have recently received 2 reports of fatal adverse reactions to the yellow fever vaccine (Stamaril). Due to an increased risk of life-threatening reactions, the vaccine must not be given to anyone with a medical history of…
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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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Prescribers should consider reducing the dose of ponatinib to 15 mg a day for patients with chronic phase chronic myeloid leukaemia (CP-CML) who have achieved a major cytogenetic response.
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Erythromycin has been associated with events secondary to QT interval prolongation such as cardiac arrest and ventricular fibrillation. Erythromycin should not be given to patients with a history of QT interval prolongation…
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Cases of interstitial lung disease and pneumonitis have been reported in patients receiving CDK4/6 inhibitors indicated for some breast cancers. Ensure that patients taking these medicines are aware of the need to seek advic…
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A summary of letters and drug alerts recently sent to healthcare professionals.
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The Commission on Human Medicines has issued a series of recommendations to strengthen measures to minimise risk with the yellow fever vaccine (Stamaril) following very rare fatal reactions. Key recommendations include new a…
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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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New maximum single intravenous dose of ondansetron for the management of chemotherapy-induced nausea and vomiting (CINV) restricted due to risk of QTc prolongation.
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You should take caution when you use NSAIDs in patients with renal impairment or are at risk.
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Use of aliskiren can cause angioedema, a rare and serious side effect, and or acute renal failure.
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Sitaxentan (Thelin▼) withdrawn due to hepatotoxicity.
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Canagliflozin may increase the risk of lower-limb amputation (mainly toes) in patients with type 2 diabetes. Evidence does not show an increased risk for dapagliflozin and empagliflozin, but the risk may be a class effect. P…
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Healthcare professionals prescribing nitrofurantoin should be alert to the risks of pulmonary and hepatic adverse drug reactions and advise patients to be vigilant for the signs and symptoms in need of further investigation.
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Risk minimisation materials are available to support the safe use of new paediatric formulations of rivaroxaban (Xarelto) and dabigatran etexilate (Pradaxa). In addition, we ask healthcare professionals to consult the curren…
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Central serous chorioretinopathy is a retinal disorder that has been linked to the systemic use of corticosteroids. Recently, it has also been reported after local administration of corticosteroids via inhaled and intranasal…
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Risk of early psychiatric side-effects is one of several important safety issues for healthcare professionals to discuss with patients and carers, who should seek urgent medical advice in the event of any worrying symptoms.
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Reports of acquired haemophilia have been received in association with clopidogrel.
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Maintenance doses of brolucizumab (after the first 3 doses) should not be given at intervals of less than 8 weeks apart.
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Use restricted to adults with advanced or metastatic breast cancer only.
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Consider progressive multifocal encephalopathy (PML) in the differential diagnosis for patients with new or worsening neurological signs or symptoms, even several years after treatment with cladribine.
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Capillary leak syndrome (CLS) has been reported in recipients of filgrastim, including patients undergoing chemotherapy and a healthy donor undergoing peripheral blood progenitor-cell mobilisation; it has also been reported …
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Risk of developing progressive multifocal leukoencephalopathy (PML) associated with natalizumab is increased in patients who have had previous immunosuppressant therapy.
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A retrospective observational study has indicated a possible association between valproate use by men around the time of conception and an increased risk of neurodevelopmental disorders in their children.
Inform male p…
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Care needed when transferring from unlicensed formulations.
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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…
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New specific guidance on dose-dependent prolongation of QTc with ondansetron.
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Updated advice on use of nicorandil as second-line treatment for stable angina - some ulcers may progress to complications unless treatment is stopped.
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Doses of theophylline, fluvoxamine, caffeine, coumarins including warfarin and the antipsychotics clozapine and olanzapine may have to be altered.
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How MHRA monitors the impact of regulatory action taken.
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Stavudine should only be used when there are no appropriate alternatives, and for the shortest possible time.
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Liver function tests should be carried out at treatment initiation, during treatment, and also when the dose is increased.