NEJM’de yayımlanan çalışma sonrası FDA, azitromisin alan hastalardaki kardiyovasküler riski inceliyor…

FDA to Review CV Risk With Azithromycin After NEJM Study

Robert Lowes

Posted: 05/17/2012

May 17, 2012 — The US Food and Drug Administration (FDA) will review a new study showing that patients taking azithromycin (Zithromax, Pfizer) face a small increased risk for sudden cardiac death compared with patients taking amoxicillin, ciprofloxacin, or no antibiotic at all, the agency announced today.

The observational study, published today in the New England Journal of Medicine (NEJM), looked at Medicaid patients on a 5-day course of azithromycin.

In its announcement, the FDA reminded clinicians that QT interval prolongation, which can trigger an abnormal and sometimes fatal heart arrhythmia called torsades de pointes (TdP), has been linked not only with azithromycin but also with other antibiotic drugs in its class. That class, called macrolides, also includes clarithromycin (Biaxin, Abbott) and erythromycin, neither of which figured into the NEJM study.