FDA Drug Safety Podcast: FDA review finds additional data supports the potential for increased long-term risks with antibiotic clarithromycin (Biaxin) in patients with heart disease

Welcome to the FDA Drug Safety Podcast for health care professionals from the Division of Drug Information.

On February 22, 2018, FDA advised caution before prescribing the antibiotic clarithromycin (brand name Biaxin) to patients with heart disease because of a potential increased risk of heart problems or death that can occur years later. FDA’s recommendation is based on a review of the results of a 10-year follow-up study of patients with coronary heart disease who were part of a large clinical trial that first observed this safety issue.

As a result, we have added a new warning about this increased risk of death in patients with heart disease, and advised prescribers to consider using other antibiotics with such patients. We have also added the study results to the clarithromycin drug labels. As part of FDA’s usual ongoing safety monitoring of drugs, we are continuing to monitor safety reports in patients taking clarithromycin.

Health care 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 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.

Clarithromycin is used to treat many types of infections affecting the skin, ears, sinuses, lungs, and other parts of the body.

We previously communicated about this safety issue in December 2005, before the 10-year follow-up study results were available.

Report side effects involving clarithromycin to FDA’s MedWatch program at www.fda.gov/medwatch.

A link to the full communication detailing specific information for health care professionals can be found at www.fda.gov/DrugSafety. If you have drug questions, you can reach us at druginfo@fda.hhs.gov.

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