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80 updates about Neurology
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Valproate medicines (Epilim▼, Depakote▼): Pregnancy Prevention Programme materials online
Use materials online now and hardcopies arriving over the coming weeks by post to ensure women and girls of childbearing potential on valproate medicines meet the requirements of the Pregnancy Prevention Programme.
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Letters sent to healthcare professionals in April 2018
Letters were sent about insulin Fiasp and Tresiba and Inhixa (enoxaparin sodium); use survey to feedback your thoughts on Direct Healthcare Professional Communications (DHPCs) and on the way medicines safety issues are communicated.
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Valproate medicines (Epilim▼, Depakote▼): contraindicated in women and girls of childbearing potential unless conditions of Pregnancy Prevention Programme are met
Valproate medicines must no longer be used in women or girls of childbearing potential unless a Pregnancy Prevention Programme is in place.
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Letters sent to healthcare professionals in March 2018
Letters were sent to healthcare professionals about Zinbryta▼ (daclizumab beta), Lynparza 50 mg capsules, and radium-223-dichloride (Xofigo▼).
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Daclizumab (Zinbryta▼): suspension and recall for safety reasons; review patients as soon as possible and start alternative therapy
The European Medicines Agency (EMA) has recommended the immediate suspension of the marketing authorisation and recall of daclizumab (Zinbryta) in the EU following reports of serious inflammatory brain disorders, including encephalitis and meningoencephalitis, in patients with multiple sclerosis.
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Letters sent to healthcare professionals in February 2018
Letters were sent about ellaOne, ERWINASE, Eperzan▼, Ocaliva▼, Velcade, Esmya, and Bleo-Kyowa.
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Gadolinium-containing contrast agents: Omniscan and iv Magnevist no longer authorised, MultiHance and Primovist for use only in liver imaging
Omniscan and intravenous Magnevist are now no longer authorised for use and a product recall of any existing unexpired stock is underway.
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Letters sent to healthcare professionals in January 2018
Letters were sent about Buccolam (midazolam), misoprostol vaginal delivery system (Mysodelle), noradrenaline, Relenza (zanamivir), mycophenolate mofetil/mycophenolic acid, Flolan, and Fludara.
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Daclizumab (Zinbryta▼) and risk of severe liver injury: new restrictions to use and strengthened liver monitoring
The use of daclizumab (daclizumab beta) is now restricted to adults with relapsing multiple sclerosis who have had an inadequate response to at least 2 other disease-modifying therapies (DMTs) and for whom other DMTs are contraindicated or unsuitable.
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Letters sent to healthcare professionals in December 2017
Letters were sent about cladribine (Litak and Leustat), radium-223-dichloride (Xofigo▼), and ERWINASE.
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Gadolinium-containing contrast agents: removal of Omniscan and iv Magnevist, restrictions to the use of other linear agents
A review has found that low levels of gadolinium can be retained in the brain and other tissues after administration of gadolinium-containing contrast agents (GdCAs).
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Cladribine (Litak, Leustat) for leukaemia: reports of progressive multifocal encephalopathy (PML); stop treatment if PML suspected
Consider progressive multifocal encephalopathy (PML) in the differential diagnosis for patients with new or worsening neurological signs or symptoms, even several years after treatment with cladribine.
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Fingolimod (Gilenya▼): new contraindications in relation to cardiac risk
Fingolimod can cause persistent bradycardia, which can increase the risk of serious cardiac arrhythmias.
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Fingolimod (Gilenya▼): updated advice about risk of cancers and serious infections
Monitor patients closely for skin cancers.
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Letters sent to healthcare professionals in November 2017
Letters were sent about eluxadoline (Truberzi), fingolimod (Gilenya), Bleo-Kyowa (bleomycin sulphate), Buccolam (midazolam), and ERWINASE.
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Quinine: reminder of dose-dependent QT-prolonging effects; updated medicine interactions
Quinine has dose-dependent QT-interval-prolonging effects and should be used with caution in patients with risk factors for QT prolongation or in those with atrioventricular block.
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Antiepileptic drugs: updated advice on switching between different manufacturers’ products
In addition to the 3 risk-based categories of antiepileptic drugs, patient-related factors should be considered when deciding whether it is necessary to maintain continuity of supply for a specific product.
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Gabapentin (Neurontin): risk of severe respiratory depression
Gabapentin has been associated with a rare risk of severe respiratory depression even without concomitant opioid medicines.
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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.