The hepatic safety profile of duloxetine: a review

Roger S McIntyre University of Toronto, Department of Psychiatry, Toronto, ON, Canada; University of Toronto, Department of Pharmacology, Toronto, ON, Canada; University Health Network, Mood Disorders Psychopharmacology Unit, 399 Bathurst Street, Toronto, ON, M5T 2S8, Canada +1 416 603 5279; +1 416 603 5368; [email protected]; University of Toronto, Institute of Medical Science, Toronto, ON, Canada

Zilomi D Panjwani University Health Network, Mood Disorders Psychopharmacology Unit, 399 Bathurst Street, Toronto, ON, M5T 2S8, Canada +1 416 603 5279; +1 416 603 5368; [email protected]

Ha T Nguyen University Health Network, Mood Disorders Psychopharmacology Unit, 399 Bathurst Street, Toronto, ON, M5T 2S8, Canada +1 416 603 5279; +1 416 603 5368; [email protected]

Hanna O Woldeyohannes University Health Network, Mood Disorders Psychopharmacology Unit, 399 Bathurst Street, Toronto, ON, M5T 2S8, Canada +1 416 603 5279; +1 416 603 5368; [email protected]

Mohammad Alsuwaidan University of Toronto, Department of Psychiatry, Toronto, ON, Canada; University Health Network, Mood Disorders Psychopharmacology Unit, 399 Bathurst Street, Toronto, ON, M5T 2S8, Canada +1 416 603 5279; +1 416 603 5368; [email protected]

Joanna K Soczynska University Health Network, Mood Disorders Psychopharmacology Unit, 399 Bathurst Street, Toronto, ON, M5T 2S8, Canada +1 416 603 5279; +1 416 603 5368; [email protected]; University of Toronto, Institute of Medical Science, Toronto, ON, Canada

Maria T Lourenco University of Toronto, Department of Psychiatry, Toronto, ON, Canada; University Health Network, Mood Disorders Psychopharmacology Unit, 399 Bathurst Street, Toronto, ON, M5T 2S8, Canada +1 416 603 5279; +1 416 603 5368; [email protected]

Jakub Z Konarski University Health Network, Mood Disorders Psychopharmacology Unit, 399 Bathurst Street, Toronto, ON, M5T 2S8, Canada +1 416 603 5279; +1 416 603 5368; [email protected]; University of Toronto, Institute of Medical Science, Toronto, ON, Canada

Sidney H Kennedy University of Toronto, Department of Psychiatry, Toronto, ON, Canada; University Health Network, Mood Disorders Psychopharmacology Unit, 399 Bathurst Street, Toronto, ON, M5T 2S8, Canada +1 416 603 5279; +1 416 603 5368; [email protected]; University of Toronto, Institute of Medical Science, Toronto, ON, Canada

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Abstract

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.

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