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Prescribing information has been updated to help to minimise the risk of serious adverse reactions in patients with cardiac disease.
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Monitoring of blood electrolytes is essential in patients coprescribed a potassium-sparing diuretic and an angiotensin converting enzyme inhibitor (ACEi) or an angiotensin receptor blocker (ARB) for heart failure.
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In light of feedback, we have clarified our article on concomitant use of these medicines in heart failure.
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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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A summary of letters sent to healthcare professionals in July 2016 to inform of safety information for riociguat and for posaconazole.
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Calciphylaxis is a very rare but serious condition causing vascular calcification and skin necrosis.
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In view of reports of serious bleeding events in patients taking miconazole and warfarin, we are considering further measures to minimise the risk of potentially serious interactions between miconazole and warfarin.
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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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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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In November, letters were sent regarding thalidomide, mycophenolate mofetil, nicorandil, InductOs, and dimethyl fumarate
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Avoid concomitant use of amiodarone with simeprevir (Olysio▼) and sofosbuvir (Sovaldi▼) combination therapy, unless other antiarrhythmics cannot be given.
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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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Avoid concomitant use of amiodarone with ledipasvir-sofosbuvir (Harvoni▼), and amiodarone with sofosbuvir (Sovaldi▼) and daclatasvir (Daklinza▼), unless other antiarrhythmics cannot be given.
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New monitoring instructions to detect these side effects as soon as possible.
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The new module helps clinicians understand how to identify, manage and avoid side effects when using corticosteroids.
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While this defect is still being investigated, we remind you to always have a full spare cylinder loaded on the delivery device so the cylinders can be switched without delay.
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Since November 2014, letters were sent regarding vismodegib (Erivedge ▼), chlorhexidine solutions, carbocisteine oral liquid (Mucodyne Paediatric 125mg/5ml), regadenoson (Rapiscan), a parenteral nutrition emulsion (Triomel),…
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New advice to minimise risk
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Reports of reconstituted solution leaking from some models of extension sets and pumps.
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Emerging clinical trial evidence of increased cardiovascular risk.
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New warnings due to risk of hyperkalaemia, hypotension, and impaired renal function have been agreed following an EU-wide review.
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Statins (HMG-CoA reductase inhibitors) are widely used medicines for patients with lipid disorders and in the primary and secondary prevention of heart attack and stroke.
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New clinical trial information is available on the timing of the loading dose of prasugrel when used in patients with unstable angina or non-ST segment elevation myocardial infarction.
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Reports of acquired haemophilia have been received in association with clopidogrel.
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Use has been restricted to 48 hours’ maximum parenteral use under specialist supervision, after a European safety review.
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Risk of serious haemorrhage—clarified contraindications apply to all 3 medicines.
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Indication restricted to second-line treatment and contraindicated with some cardiovascular conditions and medicines
Furthermore, cilostazol is now contraindicated in patients with any of the following:
Unstable ang…
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Risk of thrombosis and haemorrhage in patients with prosthetic heart valve(s) requiring anti-coagulant treatment.
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Preliminary HPS2-THRIVE trial failed to show benefit outweighs risks
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The non-identical nature of biological medicines and vaccines means it is very important that safety surveillance is carried out on a brand/product-specific basis.
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The maximum recommended dose for simvastatin in conjunction with amlodipine and diltiazem is now 20 mg/day.
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Updated contraindications and maximum dose recommendations when taken with a number of other medicines.
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Contraindications clarified and reminder to monitor renal function.
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New contraindications and warnings for combination of aliskiren (Rasilez) with angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs).
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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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Evidence does not support any increased risk of cancer in patients who use these medicines.
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Following new evidence of cardiovascular, hepatic and pulmonary risk, a review of dronedarone has concluded that the benefits of treatment continue to outweigh the risks for the maintenance of sinus rhythm after successful c…
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There is a risk of rhabdomyolysis if Systemic fusidic acid (Fucidin) is given with statins.
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Healthcare professionals should be aware of this risk when prescribing prasugrel.
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Sitaxentan (Thelin▼) withdrawn due to hepatotoxicity.
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There is an increased risk of myopathy associated with high-dose (80 mg) simvastatin. The 80-mg dose should be considered only in patients with severe hypercholesterolaemia and high risk of cardiovascular complications who h…
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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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Extension of the indication for nicotine replacement therapy (NRT) to include harm reduction.
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We continue to receive a substantial number of serious and fatal adverse event reports for warfarin through our Yellow Card Scheme.
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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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Use during breastfeeding
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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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Mothers who are breastfeeding should not take ACE inhibitors or angiotensin II receptor antagonists in the first few weeks after delivery.
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Use the central alerting system to view and search new alerts, as well as past alerts that were issued through the public health link and safety alert broadcast system.
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Updated information on supply and clinical advice on enoxaparin (Clexane) pre-filled syringes, contaminated with over-sulphated-chondroitin sulphate (OSCS).