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.
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