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Reminder on risk of serious and fatal toxicity in overdose.
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The authorisation holder for dapagliflozin has withdrawn the indication for type 1 diabetes mellitus.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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Calcitonin-containing medicines should no longer be used in treatment of osteoporosis.
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Patients with pulmonary hypertension associated with idiopathic interstitial pneumonias should not be treated with riociguat in light of interim results from a recently terminated study.
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New maximum daily dose restrictions (including in elderly patients), contraindications, and warnings.
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There are new interim treatment recommendations for idelalisib for chronic lymphocytic leukaemia and follicular lymphoma in light of new findings from clinical trials outside its currently authorised drug combinations or ind…
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…Fezolinetant should be avoided in patients with known liver disease or at a higher risk of liver disease.
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…Do not use daclizumab in patients with pre-existing hepatic disease or hepatic impairment.…
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Solu-Medrone 40 mg may contain trace amounts of milk proteins. Do not use in patients with a known or suspected allergy to cows’ milk.
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Patients should be tested for hepatitis B virus before starting treatment with BCR-ABL tyrosine kinase inhibitors.
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The Commission on Human Medicines (CHM) has temporarily restricted use of the IXCHIQ Chikungunya vaccine in people aged 65 years and over following very rare fatal reactions reported globally. This is a precautionary measure…
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Prescribing advice should be followed carefully, particularly recommended upper dose limits due to associated higher gastrointestinal risk than most other NSAIDs in the class.
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Zoledronic acid is associated with reports of renal impairment and renal failure, especially in patients with pre-existing renal dysfunction or other risk factors. Renal function should be measured before each dose, and pati…
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There have been very rare reports of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) with pseudoephedrine.
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Avoid treatment with febuxostat in patients with pre-existing major cardiovascular disease (for example, myocardial infarction, stroke, or unstable angina), unless no other therapy options are appropriate.…
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Spontaneous reporting on the Yellow Card portal has provided important information in the identification of PML associated with some drugs.
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Recent information relating to COVID-19 vaccines and medicines that has been published since the October 2021 issue of Drug Safety Update, up to 12 November 2021.
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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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Dental examination and appropriate preventive dentistry should be considered before treatment with bevacizumab or sunitinib.
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Extension of the indication for nicotine replacement therapy (NRT) to include harm reduction.
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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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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…
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Safety studies of Spiriva Respimat▼
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New study shows use of oral contraceptives reduces risk of ovarian cancer.
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Recent information relating to COVID-19 vaccines and medicines that has been published since the November 2021 issue of Drug Safety Update, up to 3 December 2021.
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There have been reports of thrombotic microangiopathy and nephrotic syndrome linked to interferon beta treatment.
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Discontinue baricitinib treatment permanently if clinical features of deep vein thrombosis or pulmonary embolism occur. Prescribers are reminded to use caution if using baricitinib in patients with risk factors for deep vein…
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While an urgent EU safety review evaluates reports of serious cardiovascular events and immune-mediated reactions, including autoimmune hepatitis, the use of alemtuzumab (Lemtrada) has been restricted and strengthened requir…
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Use baricitinib with caution in patients with diverticular disease and in those concomitantly treated with medications associated with an increased risk of diverticulitis.…
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A signal of increased lower limb amputation (primarily of the toe) in people taking canagliflozin compared with placebo in a clinical trial in high cardiovascular risk patients is currently under investigation.
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Risk of serious side effects on fertility, the liver, kidneys, immune system, blood, and heart.
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Healthcare professionals working in primary and secondary care should ensure that clinically significant immunosuppression in a patient is identified before administration of a live attenuated vaccine.
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Routine monitoring of liver function now recommended.
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A clinical trial has shown an increased risk of recurrent thrombotic events associated with rivaroxaban compared with warfarin, in patients with antiphospholipid syndrome and a history of thrombosis. Other direct-acting oral…
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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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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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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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Alerts were issued about paclitaxel drug coated balloons (DCBs) and implantable drug-eluting stents (DESs) in the treatment of patients with peripheral artery disease, and Aisys and Aisys CS2 anaesthesia devices.…
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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…
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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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Temporarily discontinue ibrutinib in patients who develop symptoms suggestive of ventricular arrhythmia and assess benefit-risk before restarting therapy. Establish hepatitis B virus status before initiating ibrutinib. Consi…
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Healthcare professionals should report any suspected adverse effects relating to fingolimod (Gilenya▼) or other treatments for multiple sclerosis, including suspected adverse effects occurring after discontinuation, via the …
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Decreased vitamin B12 levels, or vitamin B12 deficiency, is now considered to be a common side effect in patients on metformin treatment, especially in those receiving a higher dose or longer treatment duration and in those …
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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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Stop prescribing Picato and consider other treatment options for actinic keratosis as appropriate. The licence of ingenol mebutate (Picato) has been suspended as a precautionary measure while the European Medicines Agency (E…
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Recent interruption to the supply of liothyronine 20 microgram tablets from Amdipharm Mercury.
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Patients who take telbivudine and pegylated interferon are at increased risk of peripheral neuropathy and should stop taking both medicines if symptoms occur.
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The maximum adult daily dose of hydroxyzine is now 100 mg. Do not prescribe hydroxyzine to people with a prolonged QT interval or risk factors for QT interval prolongation.
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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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The immunomodulatory effects of fingolimod increase the risk of progressive multifocal leukoencephalopathy and opportunistic infections.