FDA: Clarithromycin Could Pose Danger to Heart Disease Patients

The US Food and Drug Administration (FDA) recommends exercising caution before prescribing the antibiotic clarithromycin (Biaxin) to patients with heart disease, warning that it could potentially increase the risk of future heart problems or death in this patient population.

The warning was issued following the completion of the CLARICOR trial, during which researchers observed an unexpected increase in deaths among patients with coronary heart disease within 1 year or more of receiving 2-week treatment with clarithromycin. The FDA has added these study results to the clarithromycin drug labels.

Currently, there is no clear explanation as to why clarithromycin is associated with more deaths vs placebo.

—Christina Vogt

Reference:

Clarithromycin (Biaxin): drug safety communication – potential increased risk of heart problems or death in patients with heart disease. US Food and Drug Administration. February 22, 2018. https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm597862.htm Accessed on February 23, 2018.