# 7000
Following up on a story from May of 2012, the Food and Drug Administration this morning has released a Drug Safety Communication on the popular macrolide antibiotic Azithromycin (aka Zithromax ®).
You may recall that last year, in NEJM: Cardiovascular Risks Of Taking Azithromycin I wrote about a study that found a `small absolute increase in cardiovascular deaths’ among patients taking the macrolide antibiotic Azithromycin when compared to a control group taking no antibiotics or with taking amoxicillin.
Shortly thereafter (May 17th, 2012), we saw an FDA Statement On Azithromycin & Cardiovascular Risks that included:
FDA is reviewing the results from this study and will communicate any new information that results from the FDA review.
Patients taking azithromycin should not stop taking their medicine without talking to their healthcare professional.
Healthcare professionals should be aware of the potential for QT interval prolongation and heart arrhythmias when prescribing or administering antibacterial drugs. (See additional information below.)
Fast forward nearly 10 months, and today the FDA released the following announcement:
FDA Drug Safety Communication: Azithromycin (Zithromax or Zmax) and the risk of potentially fatal heart rhythms
Safety Announcement
[3-12-2013] The U.S. Food and Drug Administration (FDA) is warning the public that azithromycin (Zithromax or Zmax) can cause abnormal changes in the electrical activity of the heart that may lead to a potentially fatal irregular heart rhythm. Patients at particular risk for developing this condition include those with known risk factors such as existing QT interval prolongation, low blood levels of potassium or magnesium, a slower than normal heart rate, or use of certain drugs used to treat abnormal heart rhythms, or arrhythmias. This communication is a result of our review of a study by medical researchers as well as another study by a manufacturer of the drug that assessed the potential for azithromycin to cause abnormal changes in the electrical activity of the heart.
The azithromycin drug labels have been updated to strengthen the Warnings and Precautions section with information related to the risk of QT interval prolongation and torsades de pointes, a specific, rare heart rhythm abnormality. Information has also been added regarding the results of a clinical QT study which showed that azithromycin can prolong the QTc interval. (see Data Summary)
Health care professionals should consider the risk of fatal heart rhythms with azithromycin when considering treatment options for patients who are already at risk for cardiovascular events (see Additional Information for Health Care Professionals below). FDA notes that the potential risk of QT prolongation with azithromycin should be placed in appropriate context when choosing an antibacterial drug: Alternative drugs in the macrolide class, or non-macrolides such as the fluoroquinolones, also have the potential for QT prolongation or other significant side effects that should be considered when choosing an antibacterial drug.
FDA released a statement on May 17, 2012, about a New England Journal of Medicine (NEJM) study that compared the risks of cardiovascular death in patients treated with the antibacterial drugs azithromycin, amoxicillin, ciprofloxacin (Cipro), and levofloxacin (Levaquin), or no antibacterial drug.1 The study reported an increase in cardiovascular deaths, and in the risk of death from any cause, in persons treated with a 5-day course of azithromycin (Zithromax) compared to persons treated with amoxicillin, ciprofloxacin, or no drug. The risks of cardiovascular death associated with levofloxacin treatment were similar to those associated with azithromycin treatment.
FDA will update health care professionals and the public with any relevant information that becomes available about azithromycin and the risk of abnormal heart rhythms.
