Background: Hepatotoxicity related to the use of duloxetine resulted in rewording of the US product insert.
Objective: To characterize the hepatic safety profile of duloxetine.
Methods: We conducted a PubMed search of all English-language articles published between January 1990 and December 2007 and contacted the manufacturer (Eli Lilly, Inc.).
Results: Elevations of alanine aminotransferase to three times the upper limit of normal occurs in 0.9-1.7% of duloxetine-treated patients versus 0.0-0.3% of placebo-treated patients. Hepatocellular, cholestatic and mixed hepatocellular-cholestatic forms of hepatic injury have been described.
Conclusion: Duloxetine does not appear to pose a greater hazard for hepatic toxicity when compared to other conventional antidepressants. Systematic monitoring of liver aminotransferases does not appear to be warranted with routine duloxetine use.