MS drug daclizumab withdrawn worldwide because of safety concerns
Daclizumab, an immunomodulatory drug used in the treatment of relapsing forms of multiple sclerosis, has been removed from the worldwide market due to mounting concerns over its safety.
The manufacturer voluntarily withdrew the drug on the same day that the European Medicines Agency announced an urgent review due to seven case reports of serious inflammatory brain disorders. Doctors should review patients currently being treated with the drug and initiate alternative therapy as soon as possible. New patients should not be started on daclizumab.
The manufacturer believes the decision is in the best interests of patients, stating “given the nature and complexity of adverse events being reported, characterising the evolving benefit/risk profile of daclizumab will not be possible going forward given the limited number of patients being treated.”
See Management: approach2017 revisions to the McDonald diagnostic criteria for multiple sclerosis
The 2017 McDonald criteria include the following changes:
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In patients with a typical clinically isolated syndrome and clinical or MRI demonstration of dissemination in space, the presence of CSF-specific oligoclonal bands allows a diagnosis of multiple sclerosis.
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Symptomatic lesions can be used to demonstrate dissemination in space or time in patients with supratentorial, infratentorial, or spinal cord syndrome; cortical lesions can be used to demonstrate dissemination in space.
Fingolimod: UK MHRA introduces new contraindications for patients with cardiovascular disorders
Fingolimod can cause persistent bradycardia, which can increase the risk of serious cardiac arrhythmias.
Following an EU review that identified 44 reports of serious ventricular tachyarrhythmia and 6 reports of sudden death worldwide, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has ruled that fingolimod is now contraindicated in patients with a history of cardiovascular disorders including (but not limited to):
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Myocardial infarction or unstable angina
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Transient ischaemic attack or stroke
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Decompensated heart failure requiring inpatient treatment or NYHA class III/IV heart failure within the last 6 months.
Summary
Definition
History and exam
Other diagnostic factors
- female
- age 20 to 40 years
- foot dragging or slapping
- leg cramping
- fatigue
- urinary frequency
- bowel dysfunction
- spasticity/increased muscle tone
- increased deep tendon reflexes
- imbalance/incoordination
- pale optic disc or non-correctable visual loss
- incorrect responses to Ishihara colour blindness test plates
- abnormal eye movements
Risk factors
- genetic factors
- female sex
- northern latitude
- smoking
- vitamin D deficiency
- autoimmune disease
Diagnostic investigations
1st investigations to order
- MRI - brain
- MRI - spinal cord
- FBC
- comprehensive metabolic panel
- thyroid-stimulating hormone (TSH)
- vitamin B12
Treatment algorithm
Contributors
Authors VIEW ALL
Staff Neurologist
Mellen Center for MS Treatment and Research
Neurological Institute
Cleveland Clinic Foundation
Cleveland
OH
Disclosures
MAW has been compensated by Biogen, Novartis, Genzyme, and Ipsen for speaking on multiple sclerosis and spasticity management. MAW also serves on the board of directors for the Multiple Sclerosis Association of America, and on the editorial board for the International Journal of MS Care.
Dr Mary Alissa Willis would like to gratefully acknowledge Dr Lael A. Stone, a previous contributor to this monograph. LAS declares that she has no competing interests.
Peer reviewers VIEW ALL
Project Leader for Neurology
Neurological Institute
Cleveland Clinic
Cleveland
OH
Disclosures
ARG declares that he has no competing interests.
Associate Professor of Neurology
Department of Clinical Neurological Sciences
London Health Sciences Centre
University Hospital
Ontario
Canada
Disclosures
SAM declares that she has no competing interests.
Director
The London Multiple Sclerosis Clinic
Associate Professor
Schulich School of Medicine
University of Western Ontario
Neurologist
Clinical Neurological Sciences Department
University Hospital
London Health Sciences Centre
Ontario
Canada
Disclosures
MK declares that he has no competing interests.
Consultant Neurologist
Department of Neurology
Queen’s Hospital
Romford
UK
Disclosures
AC declares that he has no competing interests.
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