The Food and Drug Administration (FDA) has issued a warning advising prescribers to practice caution before prescribing the common antibiotic Biaxin, aka clarithromycin, to patients with heart disease because of a “potential increased risk of heart problems or death that can occur years later.”
Biaxin is a medicine used to treat many types of infections of 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, according to the FDA, but it is not approved to treat heart disease.
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This warning is based on the results of a 10-year study of patients with coronary heart disease from a large clinical trial, named the CLARICOR trial, that first observed the issue. Within the trial, there was an unexpected increase in deaths among patients with coronary heart disease who received a two-week course of Biaxin. According to the FDA, the adverse reactions became apparent in these patients after one year or longer.
The FDA notes that there have been six observational studies published following this issue (two found evidence of long-term risks from the drug; four did not), but the prospective, placebo-controlled CLAIRCOR trial provides the strongest evidence of the increase in risk as opposed to only observational reports. However, 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, the FDA has added a new warning about this increased risk of death in patients with heart disease, have advised prescribers to consider other antibiotics instead, and have added the startling study results to all Biaxin labels.
The full report can be viewed at FDA MedWatch Alert.