Thursday, May 02, 2013

Cardiovascular Risks With Azithromycin

Azithromycin is an important antibiotic used by Pulmonologists, ENT specialists, General Practitioners and other doctors.

Azithromycin has had a recent label change which warrants this writing.

The revised label advises against the use of azithromycin in patients with known risk for QT interval prolongation, hypokalemia, hypomagnesemia, bradycardia. 

This label revision is because of post marketing surveillance findings, an observational study involving Tennessee Medicaid Patients and also Danish national healthcare data.

Excerpts"


For every 21,000 outpatient prescriptions written for azithromycin, one cardiovascular death occurred in excess of those observed with the same number of amoxicillin prescriptions. The excess risk over amoxicillin varied considerably according to cardiovascular risk factors; the researchers estimated that there was one excess cardiovascular death per 4100 prescriptions among patients at high cardiovascular risk but less than one per 100,000 among patients with lower cardiovascular risk.”


The risks and benefits of antibacterial therapy should be considered in prescribing decisions. Pharmacologic and epidemiologic data point to lethal arrhythmias as a potential consequence of QT-interval prolongation with use of azithromycin, other macrolides, and fluoroquinolones. This possibility should give clinicians pause when they're considering prescribing antibacterial drugs, especially for patients with preexisting cardiovascular risk factors or clinical conditions in which antibacterial drug therapy has limited benefits.”


Cardiovascular Risks with Azithromycin and Other Antibacterial Drugs

Andrew D. Mosholder, M.D., M.P.H., Justin Mathew, Pharm.D., John J. Alexander, M.D., M.P.H., Harry Smith, Ph.D., and Sumathi Nambiar, M.D., M.P.H.
N Engl J Med 2013; 368:1665-1668May 2, 2013DOI: 10.1056/NEJMp1302726



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