The Article in Brief
Azithromycin and Levofloxacin Use and Increased Risk of Cardiac Arrhythmia and Death
Gowtham A. Rao , and colleagues
Background Azithromycin is an antibiotic commonly prescribed for treatment of respiratory infections, urinary tract infections, and sexually transmitted diseases. In 2013, the Food and Drug Administration issued a warning on azithromycin use and the risk of potential fatal heart rhythms. This study of a national cohort of veterans investigates whether cardiac arrhythmia and mortality risks are observed in older male patients receiving azithromycin and 2 other antibiotics: amoxicillin and levofloxacin.
What This Study Found In this analysis of more than 1.6 million unique antibiotic dispensations of amoxicillin, levofloxacin, and azithromycin, there was a higher risk of death associated with azithromycin and levofloxacin therapies as compared with amoxicillin. A short-course of azithromycin therapy was associated with statistically significant hazard ratios of 1.48 for mortality risks and 1.77 serious arrhythmia risks within the first five days of treatment. The risk of these events was not significantly increased for days 6 to 10, likely due to the traditional 5-day dispensation of azithromycin. Treatment with levofloxacin, also when compared with amoxicillin, had statistically significant hazard ratios of 2.49 for mortality risk and 2.43 for serious arrhythmia risk; however, the increased risk with levofloxacin continued to be statistically significant during days 6 to 10. Levofloxacin is predominantly dispensed for a minimum of 10 days.
Implications
- These results, the authors conclude, provide support for the FDA?s recent safety announcement. They caution physicians to carefully consider the risks and benefits of antibacterial therapies when making prescription decisions.
- This study only investigated three specific antibiotics and does not determine which alternative antibiotics might be safer.