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Risk of serious side effects on fertility, the liver, kidneys, immune system, blood, and heart.
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Use of pioglitazone is associated with a small increased risk of bladder cancer. Healthcare professionals should be aware of new warnings and precautions for use in at-risk patients
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Recall will begin in September 2011 to allow sufficient time for patients to be switched to suitable alternatives.
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Supporting safer use
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Suspension of the licences (marketing authorisations) for Octagam (intravenous human normal immunoglobulin 5% and 10%) lifted.
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Use restricted to adults with advanced or metastatic breast cancer only.
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Increased risk of arterial thromboembolism, including myocardial infarction and cerebrovascular events for patients treated with thalidomide.
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Updated dosing for paediatric paracetamol liquids has been developed to ensure children receive the optimum dose for their age.
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A reminder to healthcare professionals to fill out Yellow Card reports.
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Risk of venous thromboembolism (VTE) for drospirenone-containing combined oral contraceptives (COCs), including Yasmin, is higher than for levonorgestrel-containing COCs.
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Atypical femoral fractures reported rarely with bisphosphonate therapy, mainly in patients receiving long-term treatment for osteoporosis.
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Risks of Nicobrevin outweigh any benefits.
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Healthcare professionals should be aware of this risk when prescribing prasugrel.
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Reminder to monitor and manage weight, glucose, and lipid levels.
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Use only when other antibiotics are unsuitable
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Where possible, use an appropriate alternative therapy for patients at increased risk of thrombosis.
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Stavudine should only be used when there are no appropriate alternatives, and for the shortest possible time.
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Further information is available to support safer use
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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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Prescribers should be vigilant for possible thrombotic adverse reactions.
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Patients receiving lenalidomide for management of multiple myeloma should be closely monitored for evidence of arterial and venous thromboembolic events.
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Risk of aseptic peritonitis with Dianeal, Extraneal, and Nutrineal peritoneal dialysis solutions due to possible presence of endotoxin.
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If eosinophilic pneumonia is suspected, daptomycin should be discontinued immediately and if appropriate the patient treated with corticosteroids.
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If pioglitazone is used in combination with insulin patients should be observed for signs and symptoms of heart failure, weight gain, and oedema.
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(Dextro)propoxyphene can have serious effects on the electrical activity of the heart (resulting in prolongation of the P-R and Q-T intervals, and widened QRS complexes), even at normal therapeutic doses.
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Dental examination and appropriate preventive dentistry should be considered before treatment with bevacizumab or sunitinib.
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Use in pelvic inflammatory disease only when other antibacterials are inappropriate or ineffective.
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Sitaxentan (Thelin▼) withdrawn due to hepatotoxicity.
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No evidence of increased risk of febrile convulsions in children.
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Saquinavir at a reduced dose for the first week of treatment
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Differences in dose delivery between the pump device and dropper device for memantine.
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Safety studies of Spiriva Respimat▼
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Drug interactions involving CYP2D6, genetic variants, and variability in clinical response
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Insufficient evidence to confirm a link between oral bisphosphonate use and an increased risk of oesophageal cancer.
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Report of febrile promptly.
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All healthcare professionals trained in inserting Implanon must make sure they are trained in using Nexplanon before the changeover.
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Second year safety review
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Suspension of the marketing authorisations of rosiglitazone (Avandia, Avandamet) recommended across the European Union.
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Should not be used for cough under 18 years
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Outline of the safety experience of these medicines in the UK from our proactive safety monitoring strategy.
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Prescribers should remain vigilant with regards to the similarity of these 2 drug names.
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Benefits of these medicines used in conjunction with inhaled corticosteroids (ICS) in the control of asthma symptoms in children outweigh any apparent risks.
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Check pumps after MRI.
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Risk of psychological and behavioural side effects.
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Update on managing risk of misuse.
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Erythema multiforme, Stevens Johnson syndrome and toxic epidermal necrolysis reported in association with isotretinoin - may result in hospitalisation, disability, life-threatening events, or death.
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Aluminium can be leached from glass after contact with calcium gluconate solution, leading to a risk of exposure to aluminium. Accumulation of aluminium might have adverse effects on bone mineralisation and neurological deve…
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European Medicines Agency has recommends the use of modafinil should be restricted to treat only sleepiness associated with narcolepsy - should no longer be used for obstructive sleep apnoea or chronic shift work sleep disor…
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European Medicines Agency says further measures should be put in place to minimise the risk of adverse skin reactions.