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Michael Monheit
Michael Monheit
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FDA Warns About Zithromax Heart Problems

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The popular antibiotic, Zithromax (azithromycin), marketed by Pfizer, may increase the risk of death in patients with heart disease, suggests a new study in the May issue of the New England Journal of Medicine (NEJM).

The U.S. Food and Drug Administration (FDA) is reviewing the study and plans to communicate any new information on azithromycin and this study when the review is complete.

Scientists at Vanderbilt University looked at more than 500,000 Medicaid patients in Tennessee from the period of 1992 to 2006. They determined that patients who were at risk to heart problems were two-and-a-half times more likely to die from cardiovascular events, while on Zithromax, compared to patients on Amoxicillin.

"It's a small risk. And if you look carefully, you'll see that all antibiotics have serious risks," study leader Wayne A. Ray, PhD, professor of preventive medicine at Vanderbilt University, tells WebMD. "For most patients, this is a relatively small risk."

Azithromycin belongs to class of antibacterial drugs called macrolides, which have been linked with cardiovascular effects in the past. In March 2012, the Zmax (azithromycin extended release for oral suspension) drug label was revised to include new information about the risk of prolongation of QT interval.

Patients should not stop taking Azithromycin prior to talking to their medical doctor. Healthcare professionals should be aware of the potential for QT interval prolongations and heart arrhythmias when prescribing macrolides.

Adverse effects can be reported using the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

Related: Zithromax Lawsuits