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Daclizumab was voluntarily withdrawn from the worldwide market by its manufacturer in March 2018 due to mounting concerns over its safety.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:
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Monitor for encephalitis for 12 months following discontinuation of daclizumab
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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
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Have a high index of suspicion for autoimmune encephalitis if a patient presents with atypical neuropsychiatric symptoms.
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
- 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 (TSH)
- vitamin B12
Investigations to consider
- anti-NMO antibody
- cerebrospinal fluid (CSF) evaluation
- evoked potentials
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, 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
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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