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Letters were sent about eluxadoline (Truberzi), fingolimod (Gilenya), Bleo-Kyowa (bleomycin sulphate), Buccolam (midazolam), and ERWINASE.
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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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Gabapentin has been associated with a rare risk of severe respiratory depression even without concomitant opioid medicines. Patients with compromised respiratory function, respiratory or neurological disease, renal impairmen…
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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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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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Coadministration of a corticosteroid with an HIV-treatment-boosting agent may increase the risk of adrenal suppression due to a pharmacokinetic interaction.
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Prescribing information has been updated to introduce a lower recommended dose of 60 mg daily for patients with rheumatoid arthritis or ankylosing spondylitis.
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A summary of letters sent to healthcare professionals in September 2016, including important information for professionals who specialise in epilepsy treatment regarding the withdrawal from the market of retigabine (Trobalt).
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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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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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Dental examination and appropriate preventive dentistry should be considered before treatment, especially for patients also treated with an intravenous bisphosphonate.
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Following an EU wide review of meprobamate, the remaining licence holder in the UK has ceased manufacturing and the licence will be cancelled by the end of 2016.
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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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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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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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Do not use codeine in children under 12 as it is associated with a risk of respiratory side effects. Codeine is not recommended for adolescents (12 to 18) who have problems with breathing.
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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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We remind you that a new offence will be enforced from 2 March 2015 in England and Wales. Talk to patients who are on medicines with potential to impair driving and discuss the patient leaflet advice.
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Oral diclofenac is associated with a small increased risk of cardiovascular side effects and is therefore no longer available over the counter.
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Aceclofenac is now contraindicated in patients with certain established cardiovascular diseases.
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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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We remind you to provide clear information to patients and caregivers regarding risk of accidental patch transfer and ingestion of patches, and need for appropriate disposal of patches.
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Public consultation launched on the continued availability of oral diclofenac as a pharmacy (P) medicine and on risk-minimisation measures advised by the Commission on Human Medicines.
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Restricted dose and duration of use.
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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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Safety review initiated following post-surgical fatalities in ultra-rapid metabolisers
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Risk of serious skin-related adverse drug reactions, including Stevens-Johnson syndrome, occurring with carbamazepine may be increased in the presence of the HLA-A*3101 allele in patients of European descent or Japanese orig…
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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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Further evidence that the cardiovascular risk with diclofenac is higher than other non-selective NSAIDs and similar to the selective COX-2 inhibitors.
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New simplified guidance on treating paracetamol overdose with intravenous acetylcysteine including an updated treatment nomogram.
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Levofloxacin (a fluoroquinolone antibiotic) is unfavourable as first-line treatment for several indications.
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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.
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Supporting safer use
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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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(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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European Medicines Agency says further measures should be put in place to minimise the risk of adverse skin reactions.
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Risk of accidental overdose, particularly in infants and neonates.
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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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All patients with cancer should have a dental check-up before bisphosphonate treatment.
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The tighter controls being introduced to minimise risk of overuse and or addiction of painkillers containing codeine or dihydrocodeine.
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Use of has led to serious paracetamol overdose in a 6-month-old infant.
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A reminder for those who use topical ketoprofen to avoid direct sunlight, ultraviolet rays, sunbeds or sunlamps.