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In light of feedback, we have clarified our article on concomitant use of these medicines in heart failure.
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A summary of recent safety letters sent to relevant healthcare professionals
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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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Medicines or herbal remedies that induce CYP3A4 enzymes reduce blood levels of levonorgestrel, which may reduce emergency contraceptive efficacy.
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There have been rare reports of Nexplanon implants having reached the lung via the pulmonary artery. An implant that cannot be palpated at its insertion site in the arm should be located as soon as possible and removed at th…
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In May 2016, letters were sent regarding Nexplanon (etonogestrel implant) and ERWINASE.
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Patients should be tested for hepatitis B virus before starting treatment with BCR-ABL tyrosine kinase inhibitors.
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Before starting treatment with pomalidomide, establish hepatitis B virus status in all patients.
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Healthcare professionals working in primary and secondary care should ensure that clinically significant immunosuppression in a patient is identified before administration of a live attenuated vaccine.
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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 February 2016, a letter was sent to healthcare professionals regarding medicines containing valproate.
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Children exposed to valproate in utero are at high risk of developmental disorders and congenital malformations. Use the new communication materials below to discuss these risks with patients
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Levonorgestrel-releasing intrauterine systems should always be prescribed by brand name because products have different indications, durations of use, and introducers.
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Mycophenolate mofetil and its active metabolite mycophenolic acid are associated with a high rate of serious birth defects and increased risk of spontaneous abortion.
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Osteonecrosis of the external auditory canal has been reported very rarely (fewer than 1 in 10 000 patients) with bisphosphonates, mainly in association with long-term therapy (2 years or longer).
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In November, letters were sent regarding thalidomide, mycophenolate mofetil, nicorandil, InductOs, and dimethyl fumarate
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Mirabegron is now contraindicated in patients with severe uncontrolled hypertension; advice about regular monitoring is being introduced because of cases of severe hypertension.
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A letter was sent to healthcare professionals about mirabegron for symptomatic treatment of urgency, increased
micturition frequency, or urgency incontinence.
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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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The most important risk factors for uterine perforation are insertion during lactation and insertion in the 36 weeks after giving birth. Before inserting an IUS or IUD, inform women of the risk and the symptoms of perforatio…
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Last month, letters were sent regarding ketoprofen gel, fingolimod (Gilenya▼) and efavirenz (Sustiva).
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Check full blood counts before prescribing dimethyl fumarate and then every 6 to 12 months. Stop treatment immediately if you suspect progressive multifocal leukoencephalopathy.
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The licence-holder of ferumoxytol has voluntarily withdrawn it from the UK market for commercial reasons.
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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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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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If you suspect exfoliative dermatitis caused by an adverse drug reaction to ustekinumab, stop treatment.
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Measure serum immunoglobulin levels if recurrent infections develop. Consider bronchiectasis or pulmonary fibrosis if patients develop persistent respiratory symptoms.
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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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Reports of reconstituted solution leaking from some models of extension sets and pumps.
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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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Basiliximab (Simulect) is indicated for preventing acute organ rejection only for allogeneic renal transplantation in patients receiving organ transplantation for the first time.
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There have been reports of thrombotic microangiopathy and nephrotic syndrome linked to interferon beta treatment.
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Minimising the risk of osteonecrosis of the jaw; monitoring for hypocalcaemia.
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New recommendations are being introduced to minimise the risk of serious hypersensitivity reactions with ferumoxytol.
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Emergency contraceptives remain suitable for all women regardless of the woman’s weight or body mass index (BMI).
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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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Reporting suspected adverse reactions experienced by the woman or child associated with medicines taken during pregnancy.
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Risk of tuberculosis - screen all patients before starting treatment and monitor them closely.
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Non-hormonal or progestogen-only contraception should be considered in some situations.
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St John’s wort interacts with hormonal contraceptives reducing the effectiveness and increasing the risk of unplanned pregnancy.
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Restricted indication and new monitoring requirements.
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A review of the latest evidence on the risk of thromboembolism advises to consider risk factors and remain vigilant for signs and symptoms.
- the risk of blood clots with all low-dose CHCs is small
- there is good evid…
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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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Not for use in pregnancy unless there is no effective alternative.
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Use has been restricted to 48 hours’ maximum parenteral use under specialist supervision, after a European safety review.