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    New warning on antibiotic for heart disease patients


    FDA is advising caution before healthcare professionals prescribe the antibiotic clarithromycin (Biaxin, AbbVie) to patients with heart disease due to a potential increased risk of heart problems or death that can occur years later.

    FDA’s new recommendation, detailed in a MedWatch Safety Alert, is based on a review of the results of a 10-year follow-up study of patients with coronary heart disease from a large clinical trial that first observed the safety issue.

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    The CLARICOR trial observed an unexpected increase in deaths among patients with coronary heart disease who received a two-week course of clarithromycin that became apparent after patients had been followed for one year or longer.

    “There is no clear explanation for how clarithromycin would lead to more deaths than placebo. Some observational studies also found an increase in deaths or other serious heart-related problems, while others did not,” FDA said in the Alert.

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    All the studies had limitations in how they were designed. Of the 6 observational studies published to date in patients with or without coronary artery disease, two found evidence of long-term risks from clarithromycin, and four did not.

    However, results from the prospective, placebo-controlled CLARICOR trial provide the strongest evidence of the increase in risk compared to the observational study results, FDA said.

    FDA added a new warning about this increased risk of death in patients with heart disease, and advised prescribers to consider using other antibiotics in such patients. FDA also added the study results to the clarithromycin drug labels.

    “Healthcare professionals should be aware of these significant risks and weigh the benefits and risks of clarithromycin before prescribing it to any patient, particularly in patients with heart disease and even for short periods, and consider using other available antibiotics. Advise patients with heart disease of the signs and symptoms of cardiovascular problems, regardless of the medical condition for which you are treating them with clarithromycin,” FDA said in the Alert.

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