The hepatic safety profile of duloxetine: a review.
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.


CONCLUSIONS
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.
McIntyre
Roger S
RS
University Health Network, Mood Disorders Psychopharmacology Unit, 399 Bathurst Street, Toronto, ON, M5T 2S8, Canada. roger.mcintyre@uhn.on.ca
Panjwani
Zilomi D
ZD
Nguyen
Ha T
HT
Woldeyohannes
Hanna O
HO
Alsuwaidan
Mohammad
M
Soczynska
Joanna K
JK
Lourenco
Maria T
MT
Konarski
Jakub Z
JZ
Kennedy
Sidney H
SH
D000410:Alanine Transaminase / Q000097:blood; D000928:Antidepressive Agents / Q000009:adverse effects*; D001219:Aspartate Aminotransferases / Q000097:blood; D000068736:Duloxetine Hydrochloride; D006801:Humans; D008099:Liver / Q000187:drug effects*; D013876:Thiophenes / Q000009:adverse effects*
D000928:Antidepressive Agents; D013876:Thiophenes; D000068736:Duloxetine Hydrochloride; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase