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Possible increased risk of retinopathy with epoetin beta in premature infants calls for careful consideration of options for preventing anaemia of prematurity.…
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Recombinant human erythropoietin (r-HuEPO) treatment has been associated with very rare cases of life-threatening severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS) and toxic epidermal necro…
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Over-correction of haemoglobin concentration may increase the risk of death and serious cardiovascular events in patients with chronic kidney disease; it may increase the risk of thrombosis and related complications in patie…
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A similar biological medicinal product (biosimilar) is a new biological product that has been developed to be similar to an existing biological product (“reference” product).
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Increased risk of arterial thromboembolism, including myocardial infarction and cerebrovascular events for patients treated with thalidomide.
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There have been reports of thrombotic microangiopathy and nephrotic syndrome linked to interferon beta treatment.
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New advice to minimise risk
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Take particular care when prescribing or dispensing medicines that could be confused with others (ie, they sound-alike or look-alike).
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Letters were sent to healthcare professionals about Zinbryta▼ (daclizumab beta), Lynparza 50 mg capsules, and radium-223-dichloride (Xofigo▼).…
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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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New advice for extended early monitoring for those with significant bradycardia or heart block after first dose.
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Letters were sent about daclizumab beta (Zinbryta▼), alteplase (Actilyse), Esmya (ulipristal acetate), and Xofigo▼ (radium-223-dichloride). MHRA issued alerts and recalls for batches of Nutriflex Omega Special 2500 ml and Nutriflex Lipid Special 2500 ml.…
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Healthcare professionals and patients are reminded of the risk of severe asthma attacks and increased mortality associated with overuse of SABA with or without anti-inflammatory maintenance therapy in patients with asthma. H…
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Tazocin (piperacillin/tazobactam) has been reformulated to meet European Pharmacopoeia requirements on particle size.
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Mirabegron is now contraindicated in patients with severe uncontrolled hypertension; advice about regular monitoring is being introduced because of cases of severe hypertension.
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A clinically significant interaction between carbapenems and valproic acid results in reduced valproate plasma concentrations with potential for inadequate seizure control. Concomitant use of these agents is not recommended,…
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Recent information relating to COVID-19 vaccines and medicines that has been published since the December 2022 issue of Drug Safety Update, up to 23 January 2022.
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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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Risk of developing progressive multifocal leukoencephalopathy (PML) associated with natalizumab is increased in patients who have had previous immunosuppressant therapy.
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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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Test for raised ketones in patients with ketoacidosis symptoms, even if plasma glucose levels are near-normal.
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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
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Repeat enhanced cardiovascular monitoring when restarting fingolimod after treatment interruption,
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The risk of developing progressive multifocal leukoencephalopathy (PML) with natalizumab increases after 2 years of therapy. Patients with multiple sclerosis should be informed of the risk before treatment, and again after 2…
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Prescribers should be alert for neuropsychiatric reactions in patients taking montelukast and carefully consider the benefits and risks of continuing treatment if they occur.
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Monitoring for encephalitis should continue for 12 months following discontinuation of daclizumab. Inform all patients who have discontinued daclizumab and their caregivers of the common symptoms of encephalitis and the need…
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The use of daclizumab (daclizumab beta) is now restricted to adults with relapsing multiple sclerosis who have had an inadequate response to at least 2 other disease-modifying therapies (DMTs) and for whom other DMTs are contraindicated or unsuitable.…
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Healthcare professionals prescribing montelukast should be alert to the risk of neuropsychiatric reactions in all patients including children and adolescents. Reported neuropsychiatric reactions include sleep disorders, hall…
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The immunomodulatory effects of fingolimod increase the risk of progressive multifocal leukoencephalopathy and opportunistic infections.
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Globally, there has been a very small number of reports of new-onset or aggravation of pre-existing myasthenia gravis with atorvastatin, pravastatin, lovastatin, fluvastatin, simvastatin, rosuvastatin and pitavastatin (singl…
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A summary of recent letters, medicine recalls and notifications sent to healthcare professionals.
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Perform a quantitative serum anti-JCV antibody test—including index value—to support risk stratification for progressive multifocal leukoencephalopathy. For high-risk patients, consider more frequent MRI screening.