FDA Warns Popular Antibiotic Zithromax Can Cause Fatal Irregular Heart Rhythm

The U.S. Food and Drug Administration (FDA) has warned that the antibiotic azithromycin (sold as Zithromax) can alter the electrical activity of the heart and could lead to a potentially deadly irregular heart rhythm in patients taking the drug.

In making its assessment, the agency pointed to a study published in the New England Journal of Medicine last year, which showed that patients who took Zithromax, as compared to other antibiotics, had a higher risk of developing a fatal heart rhythm condition, also known as QT prolongation.

The FDA urged caution when prescribing the drug, especially to at-risk patients who take drugs for abnormal heart rhythms; those who have low levels of magnesium or potassium in their systems; patients with slower-than-normal heart rates; or individuals who suffer from torsades de pointes – a rare condition that affects normal heart rhythms.

The FDA also stated that other antibiotics in the same class as Zithromax, called macrolides, also pose a similar risk for causing irregular heart rhythms. The agency stated it has updated Zithromax labels to apprise doctors and patients of the antibiotic’s heart risks.

Pfizer Inc., the drug giant that manufacturers Zithromax, said in an emailed statement to Reuters that the new warning will affect relatively few who take the drug. However, patients who are concerned about taking it should talk to their doctors. Sales of Zithromax exceeded $450 million in 2011.

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