A study showing a higher death rate among heart disease patients a year after taking clarithromycin (Biaxin) has led the FDA to issue an alert to the public. The CLARICOR study, which was published in the British Medical Journal, reported on data from over 4,300 Danish heart disease patients who took the antibiotic or a placebo for 14 days. Within 3 years of treatment, 9.8% of patients who took clarithromycin died, compared with 7.8% of those who took a placebo. There were no differences in death rates until a year after surgery.

Previous studies of the medication and similar drugs have not detected any increase in deaths. The FDA has not recommended any changes in the use of the drug based on the study findings. The alert is a preliminary analysis.

The FDA has discussed the findings with the Danish Medicines Agency, and the FDA's recommendation is consistent with that of the Danish agency. The FDA is attempting to get more information regarding the study and its findings.