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In April 2016, letters were sent regarding canagliflozin (Invokana▼, Vokanamet▼), BCR-ABL tyrosine kinase inhibitors, pomalidomide (Imnovid▼), and retigabine (Trobalt)
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Perform a quantitative serum anti-JCV antibody test—including index value—to support risk stratification for progressive multifocal leukoencephalopathy. For high-risk patients, consider more frequent MRI screening.
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Cases of progressive multifocal leukoencephalopathy have been reported in patients taking dimethyl fumarate for multiple sclerosis, who all had prolonged lymphopenia.
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The immunomodulatory effects of fingolimod increase the risk of progressive multifocal leukoencephalopathy and opportunistic infections.
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Patients receiving apomorphine and domperidone require an assessment of cardiac risk factors and ECG monitoring to reduce the risk of serious arrhythmia related to QT-prolongation.
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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 March 2016, letters were sent regarding SGLT2 inhibitors, insulin lispro, natalizumab, noradrenaline, radium-223 dichloride, aflibercept and idelalisib.
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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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In January 2016, letters were sent to healthcare professionals regarding fingolimod (Gilenya▼) and erlotinib (Tarceva)
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In December 2015, a letter was sent to healthcare professionals regarding Reminyl (galantamine hydrobromide).
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In November, letters were sent regarding thalidomide, mycophenolate mofetil, nicorandil, InductOs, and dimethyl fumarate
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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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We remind you that a new offence will be enforced from 2 March 2015 in England and Wales. Talk to patients who are on medicines with potential to impair driving and discuss the patient leaflet advice.
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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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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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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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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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Cold-chain storage and distribution system now been fully implemented by manufacturer.
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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.