title: Liver injury associated with dimethyl fumarate in multiple sclerosis patients.
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
  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.
  
  
  CONCLUSIONS
  Health professionals should be alerted to possible serious liver injury in patients receiving DMF.
authors.affiliation: Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: Monica A
authors.initials: MA
authors.lastname: Muñoz
authors.affiliation: Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: Corrinne G
authors.initials: CG
authors.lastname: Kulick
authors.affiliation: Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: Cindy M
authors.initials: CM
authors.lastname: Kortepeter
authors.affiliation: Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: Robert L
authors.initials: RL
authors.lastname: Levin
authors.affiliation: Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
authors.forename: Mark I
authors.initials: MI
authors.lastname: Avigan
mesh_terms: D000328:Adult; D001663:Bilirubin / Q000097:blood*; D056486:Chemical and Drug Induced Liver Injury / Q000201:enzymology* / Q000209:etiology*; D000069462:Dimethyl Fumarate / Q000009:adverse effects*; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000188:drug therapy*; D012720:Severity of Illness Index; D000637:Transaminases / Q000097:blood*
chemical_list: D007166:Immunosuppressive Agents; D000637:Transaminases; D000069462:Dimethyl Fumarate; D001663:Bilirubin
keywords: Dimethyl fumarate; drug hypersensitivity; drug-induced liver injury; multiple sclerosis