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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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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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Test for raised ketones in patients with acidosis symptoms, even if plasma glucose levels are near-normal.
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Several new high strength insulin products are now on the market. The European Medicines Agency is consulting on guidance to minimise the risk of medication error.
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Last month, letters were sent regarding ketoconazole HRA and radium-223 dichloride (Xofigo).
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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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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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New warnings due to risk of hyperkalaemia, hypotension, and impaired renal function have been agreed following an EU-wide review.
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Restricted indication and new monitoring requirements.
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The risk of foetal malformation with oral retinoids is extremely high, even when used at a low dose or for a short time during pregnancy. All oral retinoids have an associated Pregnancy Prevention Programme (PPP), which is s鈥�
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Updated prescribing advice provided.
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Recent interruption to the supply of liothyronine 20 microgram tablets from Amdipharm Mercury.
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liver-function testing recommended in patients with symptoms that may indicate liver injury.
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Care needed to minimise risk of error, including training for patients.
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The maximum recommended dose for simvastatin in conjunction with amlodipine and diltiazem is now 20 mg/day.
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There have been reports of acute pancreatitis associated with drugs in the dipeptidylpeptidase-4 (DPP-4) inhibitor class of antidiabetic agents (鈥榞liptins鈥�).
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Calcitonin-containing medicines should no longer be used in treatment of osteoporosis.
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Updated contraindications and maximum dose recommendations when taken with a number of other medicines.
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Careful monitoring of serum sodium important, co-administration of other drugs that may increase serum sodium not recommended.
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Following a review by the Commission on Human Medicines (CHM), the marketing authorisation (licence) for levothyroxine 100 microgram tablets manufactured by Teva has been suspended.
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Evidence does not support any increased risk of cancer in patients who use these medicines.
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Studies of cardiovascular risk don鈥檛 support prescribing changes.
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Use of pioglitazone is associated with a small聽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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Atypical femoral fractures reported rarely with bisphosphonate therapy, mainly in patients receiving long-term treatment for osteoporosis.
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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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Insufficient evidence to confirm a link between oral bisphosphonate use and an increased risk of oesophageal cancer.
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Suspension of the marketing authorisations of rosiglitazone (Avandia, Avandamet) recommended across the European Union.
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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鈥�
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Zoledronic acid is associated with reports of renal impairment and renal failure, especially in patients with pre-existing renal dysfunction or other risk factors. Renal function should be measured before each dose, and pati鈥�
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Contraindicated in patients with any known current cancer
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All patients with cancer should have a dental check-up before bisphosphonate treatment.
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Patients with existing meningioma or a history of meningioma must not be prescribed high-dose (鈮�25 mg per day) cyproterone acetate.
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The European Medicines Agency has advised that no change in recommendations for use is required at present.
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Continued monitoring of medicines with a black triangle status.
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High intravenous doses of methylthioninium chloride (methylene blue) should be avoided for patients being treated with serotonergic antidepressants (eg, SSRIs, clomipramine, and venlafaxine).
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There have been reports of necrotising and haemorrhagic pancreatitis in people taking exenatide some of which were fatal - stop exenatide treatment if pancreatitis is diagnosed.
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New warnings and contraindications for ergot-derived dopamine agonists due to risk of fibrosis associated with chronic use.
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Clinical trial results suggest an increased risk of atrial fibrillation for zoledronic acid (Aclasta鈻�), pamidronic acid, and possibly for alendronic acid, although the balance-risk remains favourable for bisphosphonates.
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Do not prescribe ergots to patients who have had fibrosis in the heart, lungs, or abdomen.
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A similar biological medicinal product (biosimilar) is a new biological product that has been developed to be similar to an existing biological product (鈥渞eference鈥� product).
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Healthcare professionals are encouraged to report all suspected adverse reactions (ADRs) on the yellow card porftal to melt formulations of desmopressin.
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To avoid the risk of air embolism, these products should not be infused under pressure.
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Increased risk of stroke in older women should be taken into account in prescribing decisions.
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Patients should be assessed regularly due to reported cases of suicidal ideation and suicidal behaviour during treatment with duloxetine or shortly after stopping treatment.
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Risk of early psychiatric side-effects is one of several important safety issues for healthcare professionals to discuss with patients and carers, who should seek urgent medical advice in the event of any worrying symptoms.
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Nasal formulations of desmopressin are no longer indicated for primary nocturnal enuresis.
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Before prescribing hormone-replacement therapy, healthcare professionals should consider carefully the potential benefits and risks for every woman
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Healthcare professionals should warn patients that compulsive behaviour with dopamine agonists may be dose-related.
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Patients who use products that contain maltose, xylose, or galactose should use glucose-specific monitors.