Last reviewed: April 2018
Last updated: March  2018

MS drug daclizumab withdrawn worldwide because of safety concerns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, 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

Original source of update

2017 revisions to the McDonald diagnostic criteria for multiple sclerosis

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.

See Diagnosis: criteria

Original source of update

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):

  • 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.

See Management: approach

Original source of update

Summary

Definition

History and exam

Key diagnostic factors

  • visual disturbance in one eye
  • peculiar sensory phenomena

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 disk or noncorrectable visual loss
  • incorrect responses to Ishihara color blindness test plates
  • abnormal eye movements

Risk factors

  • genetic factors
  • female gender
  • northern latitude
  • smoking
  • vitamin D deficiency
  • autoimmune disease

Diagnostic investigations

1st investigations to order

  • MRI - brain
  • MRI - spinal cord
  • CBC
  • comprehensive metabolic panel
  • TSH
  • vitamin B12
Full details

Investigations to consider

  • anti-NMO antibody
  • CSF evaluation
  • evoked potentials
Full details

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 received payment for participating on the speakers' bureaus of Biogen and Genzyme. 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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