Answers to the most common questions about the hepatic safety profile of duloxetine.

ABSTRACT

Since its first FDA approval in 2004, duloxetine has been taken by more than 5 million patients. A small fraction of patients treated with duloxetine develop elevations in liver enzymes, which generally resolve spontaneously without any change in treatment. Very rare cases (estimated 1-2 per 100,000 exposures) of idiosyncratic hepatic toxicity have been reported in patients taking duloxetine, particularly in those with substantial alcohol use and/or preexisting liver disease. In the context of more than 23,000 patients exposed during clinical trials, and more than 1.5 million patient years of exposure subsequent to product launch, the hepatic risk after exposure to duloxetine appears to be within the range identified for other therapeutic agents. Therefore, it does not warrant hepatic enzyme monitoring. As with any medication, physicians should follow prescribing guidelines and educate patients on the risks and benefits of duloxetine.