FDA Warns About Risks of Biaxin in Patients With Cardiac Disease

The FDA is warning healthcare providers about 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 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 issue.

The clinical trial, called the CLARICOR trial, observed an unexpected increase in deaths among patients with coronary heart disease who received a 2-week course of clarithromycin that became apparent after patients had been followed for 1 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. All of 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, 2 found evidence of long-term risks from clarithromycin and 4 did not.

Overall, results from the prospective placebo-controlled CLARICOR trial provide the strongest evidence of the increase in risk compared with the observational study results.

Based on these studies, FDA is unable to determine why the risk of death is greater for patients with heart disease. It 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 these patients. FDA also added the study results to the clarithromycin drug labels.

Clarithromycin is used to treat many types of infections affecting the skin, ears, sinuses, lungs, and other parts of the body, including Mycobacterium avium complex (MAC) infection, a type of lung infection that often affects people with HIV. Clarithromycin is not approved to treat heart disease.