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The product information for all Glucagon-Like Peptide-1 (GLP-1) receptor agonists and dual GLP-1/glucose-dependent insulinotropic polypeptide (GIP) receptor agonists has been further updated to highlight the potential risk o…
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Long-acting β2 agonists (LABA) should only be prescribed in conjunction with inhaled corticosteroids for the treatment of moderate to severe asthma.
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Maternal administration of magnesium sulfate for longer than 5–7 days in pregnancy has been associated with skeletal adverse effects and hypocalcaemia and hypermagnesemia in neonates. If use of magnesium sulfate in pregnancy…
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A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
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Should not be used for cough under 18 years
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Healthcare professionals prescribing montelukast should be alert to the risk of neuropsychiatric reactions in all patients including children and adolescents. Reported neuropsychiatric reactions include sleep disorders, hall…
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Sildenafil is not authorised for use in pregnancy for the treatment of intrauterine growth restriction. The STRIDER clinical trial, which was studying the use of sildenafil in pregnancy for intrauterine growth restriction, h…
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Patients who take telbivudine and pegylated interferon are at increased risk of peripheral neuropathy and should stop taking both medicines if symptoms occur.
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Healthcare professionals should be aware of epidemiological data showing a small increased risk of fractures associated with the use of TCAs and SSRIs, and should take this risk into account in their discussions with patient…
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Topical steroid products are safe and highly effective treatments for the management of a wide range of inflammatory skin diseases but have important risks, especially with prolonged use at high potency. In the coming months…
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Extension of the indication for nicotine replacement therapy (NRT) to include harm reduction.
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Monitoring blood concentrations of clozapine (Clozaril, Denzapine, Zaponex) for toxicity is now advised in certain clinical situations. Blood level monitoring of other antipsychotics for toxicity may also be helpful in certa…
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A summary of recent safety letters sent to relevant healthcare professionals
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Globally, there has been a very small number of reports of new-onset or aggravation of pre-existing myasthenia gravis with atorvastatin, pravastatin, lovastatin, fluvastatin, simvastatin, rosuvastatin and pitavastatin (singl…
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Children exposed in utero to valproate are at a high risk of serious developmental disorders (in up to 30-40% of cases) and/or congenital malformations (in approximately 10% of cases).
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A summary of recent letters and notifications sent to healthcare professionals about medicines.
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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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New study shows use of oral contraceptives reduces risk of ovarian cancer.
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In the UK, low-dose aspirin is licensed for prevention of thrombotic cerebrovascular or cardiovascular disease only in those who already have vascular disease—ie, secondary prevention.
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Patients with complete or partial dihydropyrimidine dehydrogenase (DPD) deficiency are at increased risk of severe and fatal toxicity during treatment with these medicines. All patients should be tested for DPD deficiency be…
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New guidance on contraceptive methods and frequency of pregnancy testing to reduce inadvertent exposures during pregnancy in a woman taking a medicine of teratogenic potential.
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Take the risk of cardiovascular side effects into account when prescribing tiotropium delivered via Respimat or Handihaler to patients with certain cardiac conditions, who were excluded from clinical trials of tiotropium (in…
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We are aware of reports of serious liver injuries and deaths in patients with primary biliary cholangitis with pre-existing moderate or severe liver impairment who were not adequately dose-adjusted. Follow dose reduction and…
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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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Patients should be transferred to alternative bronchodilator therapy.
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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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How pharmacists can prevent counterfeits reaching patients.
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Risk of psychological and behavioural side effects.
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Reports of acquired haemophilia have been received in association with clopidogrel.
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In view of data showing ongoing exposure to valproate in pregnancy, this article reminds healthcare professionals of the risks in pregnancy and the current Pregnancy Prevention Programme requirements, and provides informatio…
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Risks of Nicobrevin outweigh any benefits.
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…Only initiate daclizumab in restricted groups of patients with limited treatment options and keep all patients under close liver function monitoring.
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Consider progressive multifocal encephalopathy (PML) in the differential diagnosis for patients with new or worsening neurological signs or symptoms, even several years after treatment with cladribine.
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Epidemiological data suggest that the use of SSRIs in pregnancy, particularly in the later stages, may increase the risk of persistent pulmonary hypertension in the newborn. Healthcare professionals are encouraged to enquire…
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A summary of recent letters and notifications sent to healthcare professionals about medicines.
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Evaluate a patient’s individual factors for benefits and risks before initiating treatment with denosumab 60mg, particularly in those with previous vertebral fracture. Patients should not stop denosumab without specialist re…
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Prescribing advice should be followed carefully, particularly recommended upper dose limits due to associated higher gastrointestinal risk than most other NSAIDs in the class.
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Possible illicit drug use should be considered when prescribing medicines that have the potential to interact adversely.
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Healthcare professionals should monitor the use and safety of antiretroviral drugs for the treatment of HIV as they are advanced.
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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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Drug interactions involving CYP2D6, genetic variants, and variability in clinical response
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Reminder to test liver function before and during treatment.
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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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Patients with epilepsy should not take products that contain St John’s wort as any antiepileptic medicine may interact with St John’s wort.
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Surgeons reminded to have competent personnel and emergency facilities available for at least 1 hour after administration of the blue dye.
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Patients who require a liquid oral formulation of a β-agonist should be switched to a more-selective short-acting β2-agonist such as salbutamol or terbutaline.
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Reports of reconstituted solution leaking from some models of extension sets and pumps.
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Prescribers should be vigilant for possible thrombotic adverse reactions.
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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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…No treatment-related pattern in individual cancers or cancer groupings were apparent.