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.