ISSUE: FDA notified healthcare
professionals that it is aware of the study published in the New England
Journal of Medicine May 17, 2012 reporting
a small increase in cardiovascular deaths, and in the risk of death from any
cause, in persons treated with a 5-day course of azithromycin (Zithromax)
compared to persons treated with amoxicillin, ciprofloxacin, or no drug. FDA is
reviewing the results from this study and will communicate any new information
on azithromycin and this study or the potential risk of QT interval prolongation
after the agency has completed its review.
BACKGROUND: Azithromycin belongs to a class of antibacterial
drugs called macrolides, which have been associated with cardiovascular effects;
specifically, prolongation of the QT interval. In 2011, FDA reviewed macrolide
drug labeling information related to QT interval prolongation and TdP. The
WARNINGS AND PRECAUTIONS section of the Zmax drug label (azithromycin extended
release for oral suspension) was revised in March 2012 to include new
information regarding risk for QT interval prolongation, which appears to be
low. The drug labels for clarithromycin and erythromycin also contain
information about QT interval prolongation in the WARNINGS section. FDA is in
the process of updating risk information in the drug labels for additional
macrolide antibacterial drugs.
RECOMMENDATION: Patients taking azithromycin should not stop
taking their medicine without talking to their healthcare professional.
Healthcare professionals should be aware of the potential for QT interval
prolongation and heart arrhythmias when prescribing or administering macrolides.
*
Ray W. et al. N Engl J Med 2012; 366:1881-1890 May 17, 2012 DOI: 10.1056/NEJMoa1003833
Conclusions
"During 5 days of azithromycin therapy, there was a small absolute increase in cardiovascular deaths, which was most pronounced among patients with a high baseline risk of cardiovascular disease. (Funded by the National Heart, Lung, and Blood Institute and the Agency for Healthcare Quality and Research Centers for Education and Research on Therapeutics.)"
"During 5 days of azithromycin therapy, there was a small absolute increase in cardiovascular deaths, which was most pronounced among patients with a high baseline risk of cardiovascular disease. (Funded by the National Heart, Lung, and Blood Institute and the Agency for Healthcare Quality and Research Centers for Education and Research on Therapeutics.)"