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Fingolimod is associated with an increased risk of major congenital malformations including cardiac, renal, and musculoskeletal defects, when used in pregnancy. Women of childbearing potential must use effective contraceptio…
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Updated guidance to use methylphenidateto safely and effectively for attention deficit hyperactivity disorder (ADHD) in children of 6 years or older and adolescents.
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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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Febuxostat must be stopped immediately if hypersensitivity occurs and must not be re-started in patients who have ever developed a hypersensitivity reaction to febuxostat.
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Aceclofenac is now contraindicated in patients with certain established cardiovascular diseases.…
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Caution should be used in patients with known risk factors for venous thromboembolism in addition to the underlying disease.…
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Before initiating systemic vascular endothelial growth factor (VEGF) pathway inhibitors, carefully consider the risk of aneurysm and artery dissection in patients with risk factors. In patients who receive a systemic VEGF pa…
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Fluoroquinolones should only be used after careful benefit-risk assessment and after consideration of other therapeutic options in patients at risk for heart valve regurgitation (incompetence).
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…Patients with compromised respiratory function, respiratory or neurological disease, renal impairment, concomitant use of central nervous system (CNS) depressants, and elderly people might be at higher risk of experiencing severe respiratory depression.…
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Healthcare professionals should advise patients who need re-vaccination with Pneumovax II to expect a more intense reaction than after their first vaccination.
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Healthcare professionals should be aware of the updated information so they can discuss it with new and existing patients.
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Calciphylaxis is a very rare but serious condition causing vascular calcification and skin necrosis.
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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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Fingolimod can cause persistent bradycardia, which can increase the risk of serious cardiac arrhythmias. New contraindications have been introduced for patients with pre-existing cardiac disorders.
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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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Cases of serious liver injury with elevated transaminases and bilirubin have been reported during treatment with Kaftrio–Kalydeco combination therapy. In all patients, measure alanine aminotransferase (ALT), aspartate aminot…
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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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There have been reports of necrotising and haemorrhagic pancreatitis in people taking exenatide some of which were fatal - stop exenatide treatment if pancreatitis is diagnosed.
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A standardised pre-vaccination checklist has been introduced to ensure the yellow fever vaccine is indicated for the intended travel destination and to enable vaccinators to identify existing contraindications or precautions…
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In patients at risk for aortic aneurysm and dissection, fluoroquinolones should only be used after careful assessment of the benefits and risks and after consideration of other therapeutic options.
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Patients with active infection with this virus should not be treated with ofatumumab.
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Systematic reviews and meta-analyses of randomised controlled trials have highlighted a dose-dependent increased risk of atrial fibrillation in patients with established cardiovascular diseases or cardiovascular risk factors treated with omega-3-acid ethyl ester medicines compared to placebo…
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EU review confirms that the cardiovascular risk of high-dose ibuprofen (≥2400mg/day) is similar to COX 2 inhibitors and diclofenac.
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MHRA has received a small number of reports suggesting lack of efficacy (thromboembolic events) in patients taking 15 mg or 20 mg rivaroxaban on an empty stomach; remind patients to take 15 mg or 20 mg rivaroxaban tablets wi…
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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
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Be vigilant for any suspected adverse reactions associated with use of e-cigarettes or vaping (including lung injury) and report them to the MHRA via the Yellow Card scheme. In this article we provide UK case definitions of …
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New recommendations following a recent clinical trial which found that in patients with type 1 hepatorenal syndrome terlipressin may cause serious or fatal respiratory failure at a frequency higher than previously known, and…
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Tofacitinib should not be used in patients older than 65 years of age, people who are current or past smokers, or individuals with other cardiovascular (such as diabetes or coronary artery disease) or malignancy risk factors unless there are no suitable treatment alternatives.
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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.
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Monitor serum phosphate levels in patients treated with multiple high-dose administrations, or those on long-term treatment, and in those with pre-existing risk factors for hypophosphataemia. Re-evaluate ferric carboxymaltos…
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A review of the benefits and risks of alemtuzumab (including fatal reactions) in the treatment of multiple sclerosis has now concluded and recommended a revised indication, additional contraindications, and strengthened moni…
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Risks such as toxin spread reported mostly with off-label use.
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Before starting treatment with pomalidomide, establish hepatitis B virus status in all patients.
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…Patients with compromised respiratory function, respiratory or neurological disease, renal impairment; those using concomitant central nervous system (CNS) depressants; and people older than 65 years might be at higher risk of experiencing these events and adjustments in dose or dosing…
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Quinine has dose-dependent QT-interval-prolonging effects and should be used with caution in patients with risk factors for QT prolongation or in those with atrioventricular block.
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If constipation occurs during treatment with clozapine (Clozaril, Denzapine, Zaponex), it is vital that it is recognised and actively treated.
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In autoimmune conditions and some cancer therapies, methotrexate should be taken once a week; however, we continue to receive reports of inadvertent overdose due to more frequent dosing (including daily administration). New …
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Calcitonin-containing medicines should no longer be used in treatment of osteoporosis.
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Emerging clinical trial evidence of increased cardiovascular risk.
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While an urgent EU-wide review of new information on liver safety is under way, promptly review patients on treatment. Only initiate daclizumab in restricted groups of patients with limited treatment options and keep all pat…
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Advise patients treated with ingenol mebutate gel to be vigilant for new skin lesions and to seek medical advice immediately should any occur. Use with caution in patients with a history of skin cancer.
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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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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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There have been very rare reports of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) with pseudoephedrine.
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Reminder on risk of serious and fatal toxicity in overdose.
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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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Patients should be tested for hepatitis B virus before starting treatment with BCR-ABL tyrosine kinase inhibitors.
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…Do not use daclizumab in patients with pre-existing hepatic disease or hepatic impairment.…
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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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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.