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Some batches of gentamicin sulphate active pharmaceutical ingredient (API) used to manufacture gentamicin may contain higher than expected levels of histamine, which is a residual from the manufacturing process. Monitor pati…
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Quinine has dose-dependent QT-interval-prolonging effects and should be used with caution in patients with risk factors for QT prolongation or in those with atrioventricular block.
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An alert was issued about Alere HIV Combo professional HIV tests.
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Patients taking warfarin should not use over-the-counter miconazole oral gel (Daktarin). If you plan to prescribe miconazole oral gel in a patient on warfarin, you should closely monitor them and advise that if they experien…
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Alerts were issued about NovoPen Echo and NovoPen 5 insulin pens and BioMérieux antimicrobial susceptibility tests.
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Temporarily discontinue ibrutinib in patients who develop symptoms suggestive of ventricular arrhythmia and assess benefit-risk before restarting therapy. Establish hepatitis B virus status before initiating ibrutinib. Consi…
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Recent clinical trials have shown increased mortality when bendamustine (Levact) was used in combination treatments outside its approved indications. Be aware that the risk of opportunistic infections for all patients receiv…
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Letters were sent about Arsenic Trioxide (Trisenox), Uptravi▼ (selexipag), DepoCyte (cytarabine), Cinryze▼ (C1 esterase inhibitor [human]), and Clexane (enoxaparin sodium).
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Denosumab is associated with a risk of osteonecrosis of the jaw, osteonecrosis of the external auditory canal has also been reported with denosumab.
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A summary of letters sent to healthcare professionals, including an important reminder about the withdrawal of retigabine (Trobalt) from the market.
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All patients should be screened for hepatitis B before starting treatment for chronic hepatitis C with direct-acting antiviral interferon-free regimens. Patients who are co-infected with hepatitis B and C viruses are at risk…
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INR should be monitored closely during treatment of chronic hepatitis C with direct-acting antivirals in patients also receiving vitamin K antagonists (eg, warfarin), because of possible changes in liver function during trea…
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A summary of recent letters sent to relevant healthcare professionals, to inform them of updated safety information.
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Switching from posaconazole oral solution to tablets has resulted in cases of dose-related toxicity, whereas switching from tablets to oral solution has resulted in underdosing and lack of efficacy.
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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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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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In April 2016, letters were sent regarding canagliflozin (Invokana▼, Vokanamet▼), BCR-ABL tyrosine kinase inhibitors, pomalidomide (Imnovid▼), and retigabine (Trobalt)
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Perform a quantitative serum anti-JCV antibody test—including index value—to support risk stratification for progressive multifocal leukoencephalopathy. For high-risk patients, consider more frequent MRI screening.
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Cases of progressive multifocal leukoencephalopathy have been reported in patients taking dimethyl fumarate for multiple sclerosis, who all had prolonged lymphopenia.
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The immunomodulatory effects of fingolimod increase the risk of progressive multifocal leukoencephalopathy and opportunistic infections.
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Dental examination and appropriate preventive dentistry should be considered before treatment, especially for patients also treated with an intravenous bisphosphonate.
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In March 2016, letters were sent regarding SGLT2 inhibitors, insulin lispro, natalizumab, noradrenaline, radium-223 dichloride, aflibercept and idelalisib.
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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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Avoid concomitant use of amiodarone with simeprevir (Olysio▼) and sofosbuvir (Sovaldi▼) combination therapy, unless other antiarrhythmics cannot be given.
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Patient reminder cards about the risk of osteonecrosis of the jaw are being introduced; denosumab 120 mg is now contraindicated in patients with unhealed lesions from dental or oral surgery.
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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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Last month, letters were sent regarding ketoprofen gel, fingolimod (Gilenya▼) and efavirenz (Sustiva).
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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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Since November 2014, letters were sent regarding vismodegib (Erivedge ▼), chlorhexidine solutions, carbocisteine oral liquid (Mucodyne Paediatric 125mg/5ml), regadenoson (Rapiscan), a parenteral nutrition emulsion (Trio…
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A short course (3 to 7 days) may be used with caution in certain patients with an eGFR of 30 to 44 ml/min/1.73m2
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A European review identified baseline markers as predictive factors for morbidity requiring hospitalisation and mortality in cirrhotic patients.
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From October 2014 Dexamethasone 4 mg/ml injection (Organon Laboratories Limited) will be replaced by Dexamethasone 3.8 mg/ml solution for injection (Aspen Pharma Trading Limited).
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Test liver function before and during treatment and tell patients to avoid sunlight exposure.
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Risk of tuberculosis - screen all patients before starting treatment and monitor them closely.
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Initiate orlistat treatment only after careful consideration of the possible impact on efficacy of antiretroviral HIV medicines.
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Screening for hepatitis B virus is now recommended in all patients (not only those at risk of this infection) before starting treatment for all indications.
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A recent review of the prescribing information has led to strengthened warnings and new measures to help minimise risks.
To minimise the risk of these adverse reactions, mefloquine must not be used for chemoprophylaxis in…
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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 recommendations after a Europe-wide review of cardiovascular safety.
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Remember to report any suspected adverse reactions
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Please be vigilant as life-threatening errors may occur
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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 Commission on Human Medicines recommend that existing levels of monitoring, education, and awareness measures by pharmacists should be maintained.
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Healthcare professionals should advise patients and/or carers of the changes in the dose, packaging, dose dispenser and leaflet.
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Levofloxacin (a fluoroquinolone antibiotic) is unfavourable as first-line treatment for several indications.
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Previous dosing regimens for doripenem in such patients found to be insufficient.
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Healthcare professionals are reminded that chlorhexidine is known to induce hypersensitivity, including generalised allergic reactions and anaphylactic shock.
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Reminder that paediatric paracetamol liquids had been developed to ensure children receive optimum dosing for their age.