Among the patients who received 347,795 prescriptions for azithromycin, there were 29 cardiovascular deaths, a significantly higher rate than the 42 that occurred among the patients who received 1,348,672 prescriptions for amoxicillin (which does not prolong the QT interval) or the 41 that occurred among the 1,391,180 patients who took no antibiotics. Among patients with the highest baseline risk of cardiovascular disease, treatment with azithromycin, compared to amoxicillin, would have resulted in 245 additional cardiovascular deaths per million courses of the antibiotic.
As with any retrospective study, there could have been some undetected differences between the patients who received one drug or the other, but use of an appropriate non-macrolide alternative2 instead of azithromycin might be reasonable in patients with cardiovascular disease or in those who are taking other drugs that can prolong the QT interval (www.azcert.org).
1. WA Ray et al. Azithromycin and the risk of cardiovascular death. N Engl J Med 2012; 366:1881.
2. Drugs for bacterial infections. Treat Guidel Med Lett 2010; 8:43.
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Zmax (Pfizer), an extended-release oral suspension of azithromycin, has been approved by the FDA for single dose treatment of mild to moderate community acquired pneumonia (CAP) and acute bacterial sinusitis (ABS) in adults. Immediate-release azithromycin will probably become available generically later this year when its patent expires.