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Mult Scler. 2017 Dec;23(14):1947-1949. doi: 10.1177/1352458516688351. Epub 2017 Jan 13.

Liver injury associated with dimethyl fumarate in multiple sclerosis patients.

Author information

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

Abstract

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.

KEYWORDS:

Dimethyl fumarate; drug hypersensitivity; drug-induced liver injury; multiple sclerosis

PMID:
28086032
DOI:
10.1177/1352458516688351
[Indexed for MEDLINE]

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