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Restricted dose and duration of use.
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Reports of pigment changes in ocular tissue, skin, lips or nails.
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Risks such as toxin spread reported mostly with off-label use.
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Repeat enhanced cardiovascular monitoring when restarting fingolimod after treatment interruption,
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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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The growing number of oral tacrolimus products available on the market increases the potential for inadvertent switching between products, which has been associated with reports of toxicity and graft rejection. Therefore, to…
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New advice for extended early monitoring for those with significant bradycardia or heart block after first dose.
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Concerns over recent years about the use of antipsychotics to treat the behavioural and psychological symptoms of dementia (BPSD).
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New contraindications, warnings, and advice for monitoring.
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Care needed when transferring from unlicensed formulations.
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Recall will begin in September 2011 to allow sufficient time for patients to be switched to suitable alternatives.
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Further information is available to support safer use
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Risk of developing progressive multifocal leukoencephalopathy (PML) associated with natalizumab is increased in patients who have had previous immunosuppressant therapy.
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Differences in dose delivery between the pump device and dropper device for memantine.
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European Medicines Agency has recommends the use of modafinil should be restricted to treat only sleepiness associated with narcolepsy - should no longer be used for obstructive sleep apnoea or chronic shift work sleep disor…
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Medication errors and inappropriate use of the rivastigmine transdermal patch have been reported, some of which resulted in overdose. Healthcare professionals should be aware of the correct use of rivastigmine, and should ad…
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A clinically significant interaction between carbapenems and valproic acid results in reduced valproate plasma concentrations with potential for inadequate seizure control. Concomitant use of these agents is not recommended,…
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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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If patients are known to be HLA-B*1502-positive, phenytoinshould be avoided when alternative therapy can be given.
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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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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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Cold-chain storage and distribution system now been fully implemented by manufacturer.
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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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Data suggests that long-term use of carbamazepine, phenytoin, primidone, and sodium valproate is associated with decreased bone mineral density that may lead to osteopenia, osteoporosis, and increased fractures.
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Spontaneous reporting on the Yellow Card portal has provided important information in the identification of PML associated with some drugs.
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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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Antiepileptic treatment is associated with a small risk of suicidal thoughts and behaviour.
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Do not prescribe ergots to patients who have had fibrosis in the heart, lungs, or abdomen.
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Patients who take telbivudine and pegylated interferon are at increased risk of peripheral neuropathy and should stop taking both medicines if symptoms occur.
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Patients with epilepsy should not take products that contain St John’s wort as any antiepileptic medicine may interact with St John’s wort.
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To avoid the risk of air embolism, these products should not be infused under pressure.
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Products that contain botulinum toxin are associated with the risk of serious adverse reactions due to distant spread of toxin.
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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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Healthcare professionals should warn patients that compulsive behaviour with dopamine agonists may be dose-related.