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New advice to minimise risk
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To be used only in patients with acute blood loss and when crystalloids alone are not sufficient.
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Do not use in closed body cavities or on deep or large wounds.
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Reports of reconstituted solution leaking from some models of extension sets and pumps.
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A European review has considered MHRA evidence together with additional information from spontaneous reporting and published literature.
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The new offence introduced in July does not apply in Northern Ireland nor replace any existing offences of driving.
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The Department for Transport has introduced a new offence of driving with certain controlled drugs above specified limits in the blood; this is likely to come into force on 2 March 2015.
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Use a filter needle when drawing up reconstituted dantrolene solution.
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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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Cases of intraoperative floppy iris syndrome (IFIS) during cataract surgery have been reported in patients taking the atypical antipsychotics risperidone or paliperidone.
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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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Restricted dose and duration of use.
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All products to be named and prescribed as caffeine citrate.
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New advice on dilution and administration in patients age 65 years or older refers only to the indication for prevention of chemotherapy-induced nausea and vomiting.
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Codeine should only be used to relieve acute moderate pain in children older than 12 years and only if it cannot be relieved by other painkillers such as paracetamol or ibuprofen alone.
Furthermore, a significant risk of se…
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New specific guidance on dose-dependent prolongation of QTc with ondansetron.
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Clinical trials have reported an increased risk of renal dysfunction and mortality in critically ill or septic patients who received hydroxyethyl starch (HES) compared with crystalloids.
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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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Updated guidance on minimising risk of life-threatening and fatal air embolism.
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Preliminary HPS2-THRIVE trial failed to show benefit outweighs risks
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Safety review initiated following post-surgical fatalities in ultra-rapid metabolisers
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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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Do not use in children aged 16 years or less, except in specialist settings under expert medical supervision.
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New simplified guidance on treating paracetamol overdose with intravenous acetylcysteine including an updated treatment nomogram.
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New maximum single intravenous dose of ondansetron for the management of chemotherapy-induced nausea and vomiting (CINV) restricted due to risk of QTc prolongation.
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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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False blood glucose readings when used to flush arterial lines leading to incorrect insulin administration and potentially fatal hypoglycaemia.
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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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The Food and Drug Administration (FDA) has received 35 reports of chondrolysis involving patients given continuous intra-articular infusions of local anaesthetics.
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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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Patients with existing meningioma or a history of meningioma must not be prescribed high-dose (≥25 mg per day) cyproterone acetate.