Cardiac risks associated with antibiotics: azithromycin and levofloxacin

Expert Opin Drug Saf. 2015 Feb;14(2):295-303. doi: 10.1517/14740338.2015.989210. Epub 2014 Dec 10.

Abstract

Introduction: Azithromycin and levofloxacin have been shown to be efficacious in treating infections. The adverse drug events associated with azithromycin and levofloxacin were considered rare. However, the US FDA released warnings regarding the possible risk of QT prolongation with azithromycin and levofloxacin.

Areas covered: Case reports/case series, observational studies and clinical trials assessing cardiovascular risks associated with azithromycin and levofloxacin were critically reviewed, including 15 case reports/series, 5 observational studies and 5 clinical trials that investigated the cardiac risks associated azithromycin and levofloxacin.

Expert opinion: Results are discordant. Two retrospective studies utilizing large databases demonstrated an increased risk of cardiovascular death with azithromycin, when azithromycin was compared with amoxicillin. Two other retrospective studies found no difference in cardiovascular death associated with azithromycin and other antibiotics. For levofloxacin, the increased risk of cardiovascular death was only found in one retrospective study. Therefore, the risks and benefits of antibacterial therapies should be considered when making prescription decisions. This study should not preclude clinicians from avoiding azithromycin and levofloxacin. If a patient has an indication to receive an antibiotic and if azithromycin or levofloxacin is needed, it may be used, but the potential risks must be understood.

Keywords: adverse drug reactions; antibiotics; azithromycin; cardiac death; cardiovascular risks; drug safety; infections; levofloxacin; review.

Publication types

  • Review

MeSH terms

  • Anti-Bacterial Agents / adverse effects
  • Azithromycin / adverse effects*
  • Death*
  • Humans
  • Levofloxacin / adverse effects*
  • Long QT Syndrome / chemically induced*

Substances

  • Anti-Bacterial Agents
  • Levofloxacin
  • Azithromycin