FDA Warns of Long-Term Cardiovascular Mortality Risk With Clarithromycin

Study data revealed that the patients who received a 2-week course of the antibiotic observed an unexpected increase in death.

The US Food and Drug Administration (FDA) has released a warning for health care professionals to take caution before prescribing the bacterial antibiotic clarithromycin (Biaxin, AbbVie) to patients with heart disease, as it reportedly raises the risk of heart problems or death that can occur years later.

The FDA has warned about the potential adverse events associated with the drug as far back as December 2005, after the CLARICOR placebo-controlled study in Demark reported increased mortality in the patients treated with clarithromycin compared with those on placebo.

Study data revealed that the patients who received a 2-week course of the antibiotic observed an unexpected increase in death (hazard ratio [HR], 1.27; 95% CI, 1.03—1.54; P = .03) as a result of a significantly higher rate of cardiovascular mortality (HR, 1.45; 95% CI, 1.09—1.92; P = .01).

Although 4 of the 6 observational studies of the drug in both patients with and without coronary artery disease did not find evidence of long-term risk of the therapy, the FDA advised caution until more data is collected.

"Furthermore, there are no prospective, randomized, and controlled trials with prespecified long-term safety outcome measures following clarithromycin treatment in patients who do not have heart disease," the FDA notice reads. "Because we currently do not have study information in these patients, and observational studies have shown different results, we cannot determine whether results of the CLARICOR trial can be applied to patients who do not have heart disease."

CLARICOR study data has been added to the labels for the therapy, and the administration has noted that it will continue to monitor the safety reports for the patients taking the antibiotic.

The official warning for health care professionals stated that they “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 and 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.”

Meanwhile, the FDA warned that patients should let their health care professionals be aware of present heart disease, “especially when you are being prescribed an antibiotic to treat an infection.”

The therapy is currently used to treat conditions such as infections affecting the skin, ears, sinuses, lungs, and other parts of the body, including Mycobacterium avium complex (MAC) infection. Additionally, the antibiotic can also be used “off-label” to treat opportunistic infections of HIV, according to the NIH.

Providers are advised to report any clarithromycin-associated side effects to the FDA's MedWatch program.

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