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Careful monitoring of serum sodium important, co-administration of other drugs that may increase serum sodium not recommended.
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Healthcare professionals are encouraged to report all suspected adverse reactions (ADRs) on the yellow card porftal to melt formulations of desmopressin.
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Abacavir should be used in line with current treatment guidelines and with caution in patients with high cardiovascular risk factors.
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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.…
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…We also advise that periodic monitoring for patients with risk factors for vitamin B12 deficiency should be considered.
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In addition to the 3 risk-based categories of antiepileptic drugs, patient-related factors should be considered when deciding whether it is necessary to maintain continuity of supply for a specific product.…
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Risk of serious haemorrhage—clarified contraindications apply to all 3 medicines.
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…The 10 mg twice-daily dose of tofacitinib (authorised for ulcerative colitis) must not be used in patients at high risk of pulmonary embolism.…
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Statin use may be associated with a level of hyperglycaemia in some patients where formal diabetes care is appropriate.
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New recommendations after a Europe-wide review of cardiovascular safety.
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Photosensitivity reactions are known side effects of methotrexate treatment and can be severe. Patients should be advised to take precautions to protect their skin in the sun.
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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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Minimising the risk of osteonecrosis of the jaw; monitoring for hypocalcaemia.
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Calciphylaxis is a very rare but serious condition causing vascular calcification and skin necrosis.
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Increased risk of arterial thromboembolism, including myocardial infarction and cerebrovascular events for patients treated with thalidomide.
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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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A review of the latest evidence on the risk of thromboembolism advises to consider risk factors and remain vigilant for signs and symptoms.…
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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 carboxymaltose treatment in patients with persistent hypophosphataemia.…
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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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Recent epidemiological evidence of an increased risk of fracture with long-term use of proton pump inhibitors (PPIs).
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…Prescribers are reminded to use caution if using baricitinib in patients with risk factors for deep vein thrombosis or pulmonary embolism in addition to rheumatoid arthritis.…
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Test liver function before and during treatment and tell patients to avoid sunlight exposure.
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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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Healthcare professionals prescribing aripiprazole are reminded to be alert to the risk of addictive gambling and other impulse control disorders. Healthcare professionals should advise patients, their families and friends to…
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There have been rare reports of Nexplanon implants having reached the lung via the pulmonary artery. An implant that cannot be palpated at its insertion site in the arm should be located as soon as possible and removed at th…
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The European Medicines Agency has advised that no change in recommendations for use is required at present.
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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 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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Remain vigilant for signs and symptoms of bleeding complications during treatment with DOACs (apixaban, dabigatran, edoxaban, rivaroxaban), especially in patients with increased bleeding risks. Specific reversal agents are a…
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Latest evidence suggests long-term use of combined oral contraceptives or progestogen-only injectable contraceptives is associated with a small increased risk of cervical cancer.
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Patients receiving apomorphine and domperidone require an assessment of cardiac risk factors and ECG monitoring to reduce the risk of serious arrhythmia related to QT-prolongation.
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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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Warnings about the risk of severe and fatal burns are being extended to all paraffin-based emollients regardless of paraffin concentration. Data suggest there is also a risk for paraffin-free emollients. Advise patients who …
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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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Establish hepatitis B virus status before initiating daratumumab and in patients with unknown hepatitis B virus serology who are already being treated with daratumumab.
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Routine monitoring of liver function now recommended.
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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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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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Rivaroxaban treatment in patients who undergo transcatheter aortic valve replacement (TAVR) should be stopped and switched to standard of care.
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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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…For high-risk patients, consider more frequent MRI screening.
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Reports of acquired haemophilia have been received in association with clopidogrel.
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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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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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Caution is required if prescribing febuxostat in patients with pre-existing major cardiovascular disease, particularly, in those with evidence of high urate crystal and tophi burden or those initiating urate-lowering therapy.…
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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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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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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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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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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…