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Liver injury associated with dimethyl fumarate in multiple sclerosis patients

Monica A Muñoz1, Corrinne G Kulick1, Cindy M Kortepeter1

  • 1Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.

Multiple Sclerosis (Houndmills, Basingstoke, England)
|January 14, 2017
PubMed
Abstract

Insights

Post-marketing surveillance identified 14 cases of significant liver injury in patients taking dimethyl fumarate (DMF). While no cases resulted in liver failure, healthcare providers should monitor for potential hepatic adverse events.

Area of Science:

  • Hepatology
  • Pharmacovigilance
  • Drug Safety

Background:

  • Pre-approval studies noted mild, transient liver enzyme elevations with dimethyl fumarate (DMF) use.
  • Post-marketing data is crucial for identifying rare or delayed adverse events.

Purpose of the Study:

  • To investigate and characterize drug-induced liver injury (DILI) cases linked to DMF.
  • To assess the safety profile of DMF in a real-world setting.

Main Methods:

  • Retrospective analysis of spontaneous post-marketing reports.
  • Case series review of patients experiencing liver injury while on DMF.

Main Results:

  • 14 cases of clinically significant liver injury were identified.
  • Elevated liver aminotransferases and bilirubin levels were observed, with onset potentially occurring days after DMF initiation.
  • The predominant pattern of liver injury was hepatocellular; no cases progressed to liver failure.

Conclusions:

  • Dimethyl fumarate (DMF) is associated with a risk of serious drug-induced liver injury.
  • Healthcare professionals must remain vigilant for hepatic adverse events in patients prescribed DMF.
  • Early recognition and monitoring are essential for managing DMF-associated hepatotoxicity.
Keywords:
Dimethyl fumaratedrug hypersensitivitydrug-induced liver injurymultiple sclerosis

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