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, characterizing the evolving benefit/risk profile of daclizumab will not be possible going forward given the limited number of patients being treated.”See Management: approach
The 2017 McDonald criteria include the following changes:
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.
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 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):
Myocardial infarction or unstable angina
Transient ischemic attack or stroke
Decompensated heart failure requiring inpatient treatment or NYHA class III/IV heart failure within the last 6 months.
Demyelinating CNS condition clinically defined by 2 episodes of neurologic dysfunction (brain, spinal cord, or optic nerves) that are separated in space and time.
Classically presents in white women, aged between 20 to 40 years, with temporary visual or sensory loss. However, may affect either sex and any age or ethnic group, and may have variable neurological symptom location and/or duration.
May have subtle changes in vision, ambulation, and reflexes on examination that provide evidence of previous attacks (which may not have been noticed by the patient).
MRI brain is sensitive, but very susceptible to over-interpretation in the absence of clinical correlation. Spinal MRI is abnormal less often, but lends greater specificity when present with brain lesions.
Treatment of the condition can be divided into 3 parts: treatment of the acute attack; prevention of future attacks by reducing triggers and use of disease-modifying therapies; and symptomatic treatments of neurologic difficulties such as spasticity, pain, fatigue, and bladder dysfunction.
Multiple sclerosis (MS) is defined as an inflammatory demyelinating disease characterized by the presence of episodic neurologic dysfunction in at least 2 areas of the CNS (brain, spinal cord, and optic nerves) separated in time and space. 
Mellen Center for MS Treatment and Research
Cleveland Clinic Foundation
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.
Project Leader for Neurology
ARG declares that he has no competing interests.
Associate Professor of Neurology
Department of Clinical Neurological Sciences
London Health Sciences Centre
SAM declares that she has no competing interests.
The London Multiple Sclerosis Clinic
Schulich School of Medicine
University of Western Ontario
Clinical Neurological Sciences Department
London Health Sciences Centre
MK declares that he has no competing interests.
Department of Neurology
AC declares that he has no competing interests.
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