New FDA Drug Safety Communication on Biaxin (clarithromycin)

www.fda.gov

The U.S. Food and Drug Administration (FDA) is advising caution before prescribing the antibiotic clarithromycin (Biaxin) to patients with heart disease because of a potential increased risk of heart problems or death that can occur years later. The recommendation is based on our review of the results of a 10-year follow-up study1 of patients with coronary heart disease from a large clinical trial that first observed this safety issue.
As a result, the FDA has 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.
Health care professionals are advised to be aware of the 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. Patients with heart disease should be advised of the signs and symptoms of cardiovascular problems, regardless of the medical condition for which they are being treated with clarithromycin.
As part of its ongoing safety monitoring of drugs, FDA will continue to monitor safety reports in patients taking clarithromycin.

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