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November 19, 1997

Losartan-Induced Hepatotoxicity-Reply

Author Affiliations

Merck & Co, Inc West Point, Pa

JAMA. 1997;278(19):1572. doi:10.1001/jama.1997.03550190036038

Dr Bosch provides the first reported case of abnormalities of liver function of this magnitude in a patient treated with losartan documented by rechallenge. Noteworthy was the reversibility of the liver function test result abnormalities after each discontinuation of treatment with losartan.

Controlled clinical trials of losartan in nearly 3000 patients showed that abnormalities of liver function occurred at a frequency comparable with that of placebo or control agents.1 The current prescribing information for losartan states that occasional elevations of liver enzymes and/or serum bilirubin have occurred. In almost 3 years of marketing, Merck & Co, Inc has received approximately 80 reports of liver function abnormalities among an estimated 2 million patients who have received losartan. Overall, losartan remains well tolerated; as with all of our products, we will continue to monitor the safety profile of this drug.