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62 updates about Neurology
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Letters sent to healthcare professionals in July 2017
Letters were sent about ibrutinib, daclizumab, aflibercept, valproate medicines, and arsenic trioxide.
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Daclizumab (Zinbryta▼) and risk of severe liver injury: initiation in multiple sclerosis now restricted, promptly review patients already on treatment
While an urgent EU-wide review of new information on liver safety is under way, promptly review patients on treatment.
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Letters sent to healthcare professionals in April 2017, including a reminder of the retigabine (Trobalt) withdrawal
A summary of letters sent to healthcare professionals, including an important reminder about the withdrawal of retigabine (Trobalt) from the market.
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Valproate and developmental disorders: new alert asking for patient review and further consideration of risk minimisation measures
Babies born to mothers who take valproate medicines (Epilim▼, Depakote▼) during pregnancy have a 30–40% risk of developmental disability and a 10% risk of birth defects.
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Multiple sclerosis therapies: signal of rebound effect after stopping or switching therapy
Healthcare professionals should report any suspected adverse effects relating to fingolimod (Gilenya▼) or other treatments for multiple sclerosis, including suspected adverse effects occurring after discontinuation, via the Yellow Card Scheme.
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Letters sent to healthcare professionals in December 2016
A summary of letters sent to relevant healthcare professionals in December 2016.
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Letters sent to healthcare professionals in September 2016, including retigabine withdrawal
A summary of letters sent to healthcare professionals in September 2016, including important information for professionals who specialise in epilepsy treatment regarding the withdrawal from the market of retigabine (Trobalt).
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Letters sent to healthcare professionals in April 2016
In April 2016, letters were sent regarding canagliflozin (Invokana▼, Vokanamet▼), BCR-ABL tyrosine kinase inhibitors, pomalidomide (Imnovid▼), and retigabine (Trobalt)
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Natalizumab (Tysabri▼): progressive multifocal leukoencephalopathy—updated advice to support early detection
Perform a quantitative serum anti-JCV antibody test—including index value—to support risk stratification for progressive multifocal leukoencephalopathy.
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Dimethyl fumarate (Tecfidera): updated advice on risk of progressive multifocal leukoencephalopathy
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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Fingolimod (Gilenya▼): risks of progressive multifocal leukoencephalopathy, basal-cell carcinoma, and opportunistic infections
The immunomodulatory effects of fingolimod increase the risk of progressive multifocal leukoencephalopathy and opportunistic infections.
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Apomorphine with domperidone: minimising risk of cardiac side effects
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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Meprobamate: licence to be cancelled
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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Letters sent to healthcare professionals in March 2016
In March 2016, letters were sent regarding SGLT2 inhibitors, insulin lispro, natalizumab, noradrenaline, radium-223 dichloride, aflibercept and idelalisib.
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Letters sent to healthcare professionals in February 2016
In February 2016, a letter was sent to healthcare professionals regarding medicines containing valproate.
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Valproate and risk of abnormal pregnancy outcomes: new communication materials
Children exposed to valproate in utero are at high risk of developmental disorders and congenital malformations.
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Letters sent to healthcare professionals in January 2016
In January 2016, letters were sent to healthcare professionals regarding fingolimod (Gilenya▼) and erlotinib (Tarceva)
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Letters sent to healthcare professionals in December 2015
In December 2015, a letter was sent to healthcare professionals regarding Reminyl (galantamine hydrobromide).
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Letters sent to healthcare professionals in November 2015
In November, letters were sent regarding thalidomide, mycophenolate mofetil, nicorandil, InductOs, and dimethyl fumarate
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Letters sent to healthcare professionals in April 2015
Last month, letters were sent regarding ketoprofen gel, fingolimod (Gilenya▼) and efavirenz (Sustiva).
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Dimethyl fumarate (Tecfidera): fatal PML in an MS patient with severe, prolonged lymphopenia
Check full blood counts before prescribing dimethyl fumarate and then every 6 to 12 months.
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Drugs and driving: blood concentration limits set for certain drugs
We remind you that a new offence will be enforced from 2 March 2015 in England and Wales.
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Medicines related to valproate: risk of abnormal pregnancy outcomes
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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Drugs and driving: clarification for Wales, Scotland, and Northern Ireland
The new offence introduced in July does not apply in Northern Ireland nor replace any existing offences of driving.
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Interferon-beta: risk of thrombotic microangiopathy and risk of nephrotic syndrome
There have been reports of thrombotic microangiopathy and nephrotic syndrome linked to interferon beta treatment.
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Drugs and driving: blood concentration limits to be set for certain controlled drugs in a new legal offence
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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Zolpidem: risk of drowsiness and reduced driving ability
Taking zolpidem is associated with a risk of impaired driving ability the next day.
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Methysergide: serious fibrotic reactions
Restricted use and new monitoring requirements.
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Risperidone and paliperidone: risk of intraoperative floppy iris syndrome in patients undergoing cataract surgery
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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Sodium valproate: Risk of neurodevelopmental delay in children following maternal use
Not for use in pregnancy unless there is no effective alternative.
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Mefloquine: strengthened warnings on neuropsychiatric side effects
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 patients with active or a history of psychiatric disturbances such as depression, anxiety disorders, schizophrenia, or other psychiatric disorders.
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Antiepileptic drugs: new advice on switching between different manufacturers’ products for a particular drug
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 of seizure control.
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Metoclopramide: risk of neurological adverse effects
Restricted dose and duration of use.
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Retigabine (Trobalt▼): indication restricted to last-line use and new monitoring requirements
Reports of pigment changes in ocular tissue, skin, lips or nails.
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Botulinum toxin type B (Neurobloc): serious known risks
Risks such as toxin spread reported mostly with off-label use.
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Fingolimod (Gilenya▼): bradycardia and heart block
Repeat enhanced cardiovascular monitoring when restarting fingolimod after treatment interruption,
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Carbamazepine, oxcarbazepine and eslicarbazepine: potential risk of serious skin reactions
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 origin.
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Reporting suspected adverse drug reactions to vaccines and biological medicines
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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Antipsychotics: initiative to reduce prescribing to older people with dementia
Concerns over recent years about the use of antipsychotics to treat the behavioural and psychological symptoms of dementia (BPSD).
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Atomoxetine (Strattera▼): increases in blood pressure and heart rate
New contraindications, warnings, and advice for monitoring.
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Buccal midazolam (Buccolam▼): new authorised medicine for paediatric use
Care needed when transferring from unlicensed formulations.
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Vimpat▼ (lacosamide) 15 mg/mL syrup: recall due to quality defect
Recall will begin in September 2011 to allow sufficient time for patients to be switched to suitable alternatives.
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Modafinil (Provigil): now restricted to narcolepsy
Further information is available to support safer use
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Natalizumab (Tysabri▼): risk of progressive multifocal leukoencephalopathy is increased in patients who have had previous immunosuppressant treatment
Risk of developing progressive multifocal leukoencephalopathy (PML) associated with natalizumab is increased in patients who have had previous immunosuppressant therapy.
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Memantine pump device (Ebixa): risk of medication errors
Differences in dose delivery between the pump device and dropper device for memantine.
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Modafinil: restricted use recommended
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 disorder.
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Rivastigmine (Exelon) transdermal patch: risk of medication errors
Medication errors and inappropriate use of the rivastigmine transdermal patch have been reported, some of which resulted in overdose.
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Carbapenems: concomitant use with valproic acid not recommended
A clinically significant interaction between carbapenems and valproic acid results in reduced valproate plasma concentrations with potential for inadequate seizure control.
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Natalizumab (Tysabri▼): risk of progressive multifocal leukoencephalopathy increases after 2 years of therapy
The risk of developing progressive multifocal leukoencephalopathy (PML) with natalizumab increases after 2 years of therapy.
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Phenytoin: risk of Stevens-Johnson syndrome associated with HLA-B*1502 allele in patients of Thai or Han Chinese ethnic origin
If patients are known to be HLA-B*1502-positive, phenytoinshould be avoided when alternative therapy can be given.