Last reviewed: February 2019
Last updated: February  2019
10 Oct 2018

New daclizumab alert: encephalitis cases reported several months after discontinuation

Prescribers are being advised to contact patients who have discontinued daclizumab to ensure they are aware of the symptoms of immune-mediated encephalitis after cases were reported several months after discontinuing the drug.

Daclizumab was voluntarily withdrawn from the worldwide market by its manufacturer in March 2018 due to mounting concerns over its safety. Physicians were advised then to switch patients to an alternative treatment as soon as possible.

Now the UK Medicines and Healthcare products Regulatory Agency has issued updated advice stating that clinicians should:

  • Monitor for encephalitis for 12 months following discontinuation of daclizumab

  • Ensure all patients who have discontinued daclizumab and their carers are aware of the common prodromal symptoms and early neuropsychiatric, behavioural, neurological, cognitive, or movement-related symptoms of encephalitis and the need to contact their doctor immediately if they occur

  • Have a high index of suspicion for autoimmune encephalitis if a patient presents with atypical neuropsychiatric symptoms.

See Management: approach

Original source of update



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 disc or non-correctable visual loss
  • incorrect responses to Ishihara colour blindness test plates
  • abnormal eye movements

Risk factors

  • female sex
  • genetic factors
  • northern latitude
  • smoking
  • vitamin D deficiency
  • autoimmune disease
  • Epstein-Barr virus (EBV)

Diagnostic investigations

1st investigations to order

  • MRI - brain
  • MRI - spinal cord
  • FBC
  • comprehensive metabolic panel
  • thyroid-stimulating hormone
  • vitamin B12
Full details

Investigations to consider

  • anti-neuromyelitis optica antibody
  • cerebrospinal fluid evaluation
  • evoked potentials
Full details

Treatment algorithm


Authors VIEW ALL

Staff Neurologist

Mellen Center for MS Treatment and Research

Neurological Institute

Cleveland Clinic Foundation




MAW has received payment for participating on the speakers' bureaus of Biogen, Genzyme, and Novartis. MAW also serves 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 topic. LAS declares that she has no competing interests.

Peer reviewers VIEW ALL

Project Leader for Neurology

Neurological Institute

Cleveland Clinic




ARG declares that he has no competing interests.

Associate Professor of Neurology

Department of Clinical Neurological Sciences

London Health Sciences Centre

University Hospital




SAM declares that she has no competing interests.


The London Multiple Sclerosis Clinic

Associate Professor

Schulich School of Medicine

University of Western Ontario


Clinical Neurological Sciences Department

University Hospital

London Health Sciences Centre




MK declares that he has no competing interests.

Consultant Neurologist

Department of Neurology

Queen’s Hospital




AC declares that he has no competing interests.

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