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The risk of developing progressive multifocal leukoencephalopathy (PML) with natalizumab increases after 2 years of therapy. Patients with multiple sclerosis should be informed of the risk before treatment, and again after 2…
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Needs a summary
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Recent epidemiological evidence suggests a possible small increased risk of congenital cardiac defects in association with fluoxetine in early pregnancy, similar to that seen with paroxetine. There are insufficient data to d…
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The Food and Drug Administration (FDA) has received 35 reports of chondrolysis involving patients given continuous intra-articular infusions of local anaesthetics.
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Risk of intraocular lens opacification.
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A recent Europe-wide review of the safety information for alli has led to a number of updates, which bring the product information in line with that for Xenical.
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Extension of the indication for nicotine replacement therapy (NRT) to include harm reduction.
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Evidence indicates risks outweigh benefits.
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No unexpected new safety issues have been identified from Yellow Card reports.
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Gadolinium-containing contrast agents are associated with a varying degree of risk of nephrogenic systemic fibrosis. See advice below to minimise risk in the following vulnerable groups: patients with renal impairment; patie…
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The design and content of the Patient Information Leaflets for methylphenidate products are being updated with the latest guidance on safe and effective use for patients and carers
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If patients are known to be HLA-B*1502-positive, phenytoinshould be avoided when alternative therapy can be given.
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Patients should be advised to promptly report to their doctor any changes in their breast tissue such as lumps, pain, or nipple discharge.
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A case of progressive multifocal leukoencephalopathy (PML) with a fatal outcome was reported in a patient with rheumatoid arthritis who had not previously received treatment with methotrexate or a TNF antagonist.
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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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Batches of this medicine are being recalled from the market because of low levels of microbial contamination.
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Cases of severe hypersensitivity syndromes, sometimes fatal, have been reported with etravirine.
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Reminder on risk of serious and fatal toxicity in overdose.
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A certification mark has been designed and launched as an additional visible symbol.
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All patients with cancer should have a dental check-up before bisphosphonate treatment.
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Mixing drugs together, where one is not a vehicle for the administration of the other, creates an unlicensed medicine.
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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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There is no known interaction between oseltamivir and aspirin but aspirin must not be given to anyone younger than 16 year.
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If new movement disorders occur during treatment consider dose reduction or a gradual discontinuation of treatment in consultation with specialist advice.
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Healthcare professionals should be aware of the updated information so they can discuss it with new and existing patients.
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Updated advice for healthcare professionals not to mix or infuse ceftriaxone with solutions containing calcium.
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Doses of theophylline, fluvoxamine, caffeine, coumarins including warfarin and the antipsychotics clozapine and olanzapine may have to be altered.
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The human papillomavirus (HPV) immunisation programme is now entering its second year and this article summarises the safety experience to date.
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The study found no clear evidence that varenicline was associated with an increased risk of fatal or non-fatal self-harm.
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Patients with existing meningioma or a history of meningioma must not be prescribed high-dose (≥25 mg per day) cyproterone acetate.
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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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The European Medicines Agency has advised that no change in recommendations for use is required at present.
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How to reduce risk of illicit use.
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How MHRA monitors the impact of regulatory action taken.
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Important to inquire if patients are taking herbal medicines.
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Cold-chain storage and distribution system now been fully implemented by manufacturer.
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Use of has led to serious paracetamol overdose in a 6-month-old infant.
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Overall benefits of long-acting β-agonists (LABAs) in the treatment of chronic obstructive pulmonary disease (COPD) continue to outweigh any risks.
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Use during breastfeeding
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Healthcare professionals should consider a dose reduction or discontinuation of mycophenolate mofetil if patients develop pure red cell aplasia.
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Abacavir should be used in line with current treatment guidelines and with caution in patients with high cardiovascular risk factors.
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A reminder for those who use topical ketoprofen to avoid direct sunlight, ultraviolet rays, sunbeds or sunlamps.
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New safety information for intensive monitoring of Erlotinib.
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Topical oral salicylate gels are no longer indicated for people younger than 16 years for pain associated with infant teething, orthodontic devices, cold sores, or mouth ulcers.
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How pharmacists can prevent counterfeits reaching patients.
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Continued monitoring of medicines with a black triangle status.
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Use of Antipsychotic may be associated with an increased risk of venous thromboembolic events.
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These medicines are not first-line options for insomnia.
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You should take caution when you use NSAIDs in patients with renal impairment or are at risk.
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Use of aliskiren can cause angioedema, a rare and serious side effect, and or acute renal failure.