Drug Safety Communication for Clarithromycin (Biaxin)

PUBLISHED: Feb 23, 2018
Relevant to: Ambulatory Care, Critical Access Hospitals, Hospitals, Long Term Care, Medical Office, Pharmacy, Rural Health Clinics

The US 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. FDAs 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.

The large clinical trial, called 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. 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, 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. FDA also added the study results to the clarithromycin drug labels. As part of FDA’s usual ongoing safety monitoring of drugs, they are continuing to monitor safety reports in patients taking clarithromycin.

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.

Recommendations for Healthcare Professionals:

  • Be aware of the above described 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; also 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.

The Drug Safety Communication also contains recommendations for patients. Follow the link below to review the safety communication in its entirety.

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