FDA Reviewing Labeling for Azithromycin, Other Macrolides

FDA on May 17 announced that it is reviewing the results of a federally funded study that found an increased risk of death in patients treated with azithromycin compared with those receiving amoxicillin or ciprofloxacin or people not receiving antimicrobial therapy.

The study, which was reported in the New England Journal of Medicine (NEJM), analyzed data from patients enrolled in Tennessee's Medicaid program.

According to the report, patients taking a five-day course of azithromycin were about 2.5 times as likely as those treated with amoxicillin to die from a cardiovascular event and twice as likely to die from any cause. That equates to 47 excess deaths per million treatment courses, according to the report's authors.

In its statement, FDA noted that the increase in cardiovascular deaths was small and similar to the increase associated with levofloxacin treatment.

The agency advised patients not to stop taking azithromycin without first contacting their health care provider.

FDA said it reviewed the labeling for azithromycin and other macrolides for cardiac-risk-related information last year. This resulted in the addition of new information about azithromycin's apparently low potential to prolong the QT interval or cause Torsades de pointes.

Azithromycin was the only macrolide evaluated in the NEJM study, FDA noted.

The agency stated that it is currently updating risk information in the labeling for other macrolides and will release the information when it completes its review.