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FDA issues cardiac death on antibiotic drug Zithromax

Filed May 21st, 2012 Laurie

The Food and Drug Administration has issued a warning about an increased risk of death for patients taking the popular antibiotic drug Zithromax (azithromycin).

The agency said in a statement late last week that its decision is based on the results of a study recently published in New England Journal of Medicine that linked use of Zithromax, sold commonly as a five-day treatment called a Z-pack, to an increased risk of cardiovascular death. This risk has commonly been associated with other antibiotic drugs like Cipro and Levaquin but no study prior to this had noted any similar risks with Zithromax.

The study suggests that amoxicillin is the preferred method of antibiotic drug treatment if patients already present a heart disease or are at risk of heart disease or other heart problems. The risk of sudden cardiac death has never been linked to amoxicillin.

In its statement, the FDA said, “Healthcare professionals should be aware of the potential for QT interval prolongation and heart arrhythmias when prescribing or administering antibacterial drugs.” The agency has updated the safety labels of Zithromax to indicate this risk. It was also investigating this risk and if it’s associated with any other drugs in the Zithromax class of antibiotics, macrolides.

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