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Clarithromycin Linked to Increased Risk of Heart Problems or Death in Patients with Heart Disease

Washington, DC: The US Food and Drug Administration (FDA) has issued an advisory for health care professionals concerning the use of antibiotic clarithromycin (Biaxin) in patients with heart disease. The issue is 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 this safety issue.

In their communication, the FDA cites the large clinical trial, CLARICOR, which saw 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.

The agency notes 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 the studies had limitations in how they were designed. Of the six 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. Overall, results from the prospective, placebo-controlled CLARICOR trial provide the strongest evidence of the increase in risk compared to the observational study results. Based on these studies, the FDA is unable to determine why the risk of death is greater for patients with heart disease.

As a result, 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. Further, the FDA has 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 human immunodeficiency virus (HIV). Clarithromycin is not approved to treat heart disease.

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Published on Feb-22-18


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