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FDA Issues Statement On Zithromax Death Risk

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The U.S. Food & Drug Administration (FDA) just issued a statement concerning study that suggests death risks associated with antibiotic, Zithromax (azithromycin), are greater in heart disease patients. The study appears in the New England Journal of Medicine.

The FDA announced that it is aware of the research that studied cardiovascular death risks in patients treated with Zithromax (azithromycin), amoxicillin, Cipro (ciprofloxacin), Levaquin (levofloxacin), and no antibacterial drug. The study reported a small increase in cardiovascular deaths, and in the risk of death from any cause, in people treated with a five-day course of Zithromax, versus people treated with amoxicillin, Cipro, or no drug. The risks of cardiovascular death associated with Levaquin were similar to those seen in Zithromax treatment.

The FDA noted that it is reviewing the study’s results and will communicate any new information that results from its review. Also, said the agency, patients taking Zithromax should not stop taking their medicine without speaking with their healthcare professional; healthcare professionals should be aware of the potential for QT interval prolongation and heart arrhythmias when prescribing or administering antibacterial drugs.

Azithromycin belongs to a class of antibacterial drugs called macrolides, which have been associated with cardiovascular effects; specifically, prolongation of the QT interval, which can lead to torsades de pointes (TdP), an abnormal and sometimes fatal heart rhythm. Zithromax, also known as Zmax, was the only macrolide examined in the study, which did not review other drugs in this class, such as Biaxin (clarithromycin) and erythromycin.

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 March 2012 to include new information regarding risks for QT interval prolongation, which is considered low. The drug labels for clarithromycin and erythromycin also contain information about QT interval prolongation in the label’s “Warnings” section. The FDA noted that it is updating drug label risk information for additional macrolide antibacterial medications.

FDA-approved indications for Zithromax include: Acute bacterial exacerbations of chronic pulmonary disease, acute bacterial sinusitis, community-acquired pneumonia, pharyngitis/tonsillitis, uncomplicated skin and skin structure infections, urethritis and cervicitis, and genital ulcer disease.

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