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Clarithromycin (Biaxin, Biaxin XL) - study shows increased cardiovascular mortality

December 13, 2005

A placebo controlled study with 4373 Danish patients (CLARICOR) has shown an increase in mortality for patients taking a 14 day course of clarithromycin (Biaxin, Biaxin XL) compared to placebo. The cardiovascular mortality (hazard ratio 1.45 (95% CI 1.09 to 1.92; p=0.01) and overall mortality (1.27, 1.03 to 1.54; p=0.03) were increased in patients taking clarithromycin compared to placebo. The increase in mortality was observed in patients who were followed for one year.  Previous trials using clarithromycin have not shown an increase in patient mortality and the mechanism has not been identified.  The FDA and Danish Medicines Agency are not recommending any changes to clarithromycin use at this time.  However, alert patients and providers to exercise caution when using clarithromycin in patients with a history of myocardial infarction or angina pectoris.

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Updated
December 13, 2005; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.