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Reminder to test liver function before and during treatment.
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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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There have been reports of thrombotic microangiopathy and nephrotic syndrome linked to interferon beta treatment.
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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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Taking zolpidem is associated with a risk of impaired driving ability the next day.
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Restricted use and new monitoring requirements.
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Cases of intraoperative floppy iris syndrome (IFIS) during cataract surgery have been reported in patients taking the atypical antipsychotics risperidone or paliperidone.
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Not for use in pregnancy unless there is no effective alternative.
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A recent review of the prescribing information has led to strengthened warnings and new measures to help minimise risks.
To minimise the risk of these adverse reactions, mefloquine must not be used for chemoprophylaxis in…
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Different antiepileptic drugs (AEDs) vary considerably in their characteristics, which influences the risk of whether switching between different manufacturers’ products of a particular drug may cause adverse effects or loss…
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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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Liver function tests should be carried out at treatment initiation, during treatment, and also when the dose is increased.
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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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New maximum daily dose restrictions (including in elderly patients), contraindications, and warnings.
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Care needed when transferring from unlicensed formulations.
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A UK and Europe-wide review of available efficacy and safety data confirmed that reboxetine has benefit over placebo in its authorised indication.
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Risk of extrapyramidal effects or withdrawal symptoms (or both) in newborns after maternal use of antipsychotics during the third trimester of pregnancy.
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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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Supporting safer use
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Risks of Nicobrevin outweigh any benefits.
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Reminder to monitor and manage weight, glucose, and lipid levels.
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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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Healthcare professionals should be aware of epidemiological data showing a small increased risk of fractures associated with the use of TCAs and SSRIs, and should take this risk into account in their discussions with patient…
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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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Epidemiological data suggest that the use of SSRIs in pregnancy, particularly in the later stages, may increase the risk of persistent pulmonary hypertension in the newborn. Healthcare professionals are encouraged to enquire…
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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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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 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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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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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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Cold-chain storage and distribution system now been fully implemented by manufacturer.
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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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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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Updated guidance to use methylphenidateto safely and effectively for attention deficit hyperactivity disorder (ADHD) in children of 6 years or older and adolescents.
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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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Atomoxetine is associated with treatment-emergent psychotic or manic symptoms in children and adolescents - consider stopping this if symptoms occur.
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New warnings and contraindications for ergot-derived dopamine agonists due to risk of fibrosis associated with chronic use.