Liver injury associated with dimethyl fumarate in multiple sclerosis patients

• Published in: Multiple sclerosis Vol. 23; no. 14; pp. 1947 - 1949
• Main Authors: Muñoz, Monica A, Kulick, Corrinne G, Kortepeter, Cindy M, Levin, Robert L, Avigan, Mark I
• Format: Journal Article
• Language: English
• Published: London, England SAGE Publications 01-12-2017; Sage Publications Ltd
• Subjects: Adult; Bilirubin; Bilirubin - blood; Chemical and Drug Induced Liver Injury - enzymology; Chemical and Drug Induced Liver Injury - etiology; Clinical trials; Dimethyl Fumarate - adverse effects; Female; Humans; Immunosuppressive Agents - adverse effects; Liver; Liver diseases; Male; Medical personnel; Middle Aged; Multiple sclerosis; Multiple Sclerosis - drug therapy; Severity of Illness Index; Transaminases - blood; drug-induced liver injury; drug hypersensitivity; Dimethyl fumarate; multiple sclerosis
• ISSN: 1352-4585; 1477-0970
• DOI: 10.1177/1352458516688351

Background:
In pre-approval trials, there was an increased incidence of mild, transient elevations of liver aminotransferases in study subjects treated with dimethyl fumarate (DMF).
Objective/methods:
To evaluate post-marketing cases of drug-induced liver injury associated with DMF.
Results:
We identified 14 post-marketing cases of clinically significant liver injury. Findings included newly elevated serum liver aminotransferase and bilirubin levels that developed as early as a few days after the first dose of DMF. The pattern of liver injury was primarily hepatocellular. No cases resulted in liver failure.
Conclusion:
Health professionals should be alerted to possible serious liver injury in patients receiving DMF.