In March 2013, the U.S. Food and Drug Administration (FDA) issued a warning to doctors and patients about azithromycin – a popular antibiotic drug commonly sold as Zithromax or Zmax, packaged as “Z-Pak” and manufactured by Pfizer, among others. These medications can cause abnormal changes in the heart’s electrical activity, which may lead to a fatal irregular heart rhythm, the FDA says.
According to the FDA, certain patients face a particular risk of developing abnormal heart rhythm from using Zithromax (azithromycin). These are patients with:
- Known risk factors such as existing QT interval prolongation (or abnormal heart rhythm)
- Low blood levels of potassium or magnesium
- A slower-than-normal heart rate
- Use of certain drugs for treatment of abnormal heart rhythm.
If you or a loved one of yours has experienced a serious heart condition after taking Zithromax, you should contact Salvi, Schostok & Pritchard P.C., by calling our toll-free number or submitting our online form. We are committed to protecting the rights of consumers and securing compensation for those harmed by dangerous drugs.
FDA Zithromax Warning: A Reaction to Recent Studies Showing Increased Risk
The FDA says it issued the warning about Zithromax after reviewing two recent studies – one done by the drug’s manufacturer, Pfizer, and one done by medical researchers that the New England Journal of Medicine published in May 2012.
Zithromax is commonly prescribed for treating bronchitis, pneumonia, sore throats and earaches and infections, according to the New York Times. In 2011 alone, doctors wrote 55.3 million prescriptions for azithromycin in the U.S., the Times said.
According to the FDA, Zithromax (azithromycin) belongs to a class of anti-bacterial drugs called macrolides. In the study published in the New England Journal of Medicine, Zithromax was the only macrolide that the researchers analyzed, the FDA says. The study found an increase in cardiovascular deaths in patients treated with a five-day course of Zithromax compared to those treated with amoxicillin, Cipro (ciprofloxacin) or no drug at all.
The FDA says it has updated the Warnings and Precautions section of the drug’s labeling to include information about the risks. According to CNN.com, Pfizer has issued a statement saying that the FDA’s warning does not apply to the majority of Zithromax users. Patients should consult their doctor before discontinuing use of the drug, the FDA says.
Legal Options for Azithromycin / Zithromax / Zmax / Z-Pak Users
If you or a loved one of yours has developed abnormal heart rhythm or other cardiac issues after taking Zithromax (azithromycin), you may have the legal right to hold the manufacturer and distributor of this drug accountable for the harm you have endured.
The lawyers of Salvi, Schostok & Pritchard P.C., can review your case and advise you of your legal options. To schedule a free, no-obligation consultation, call us today toll-free or complete our online form.
- FDA Drug Safety Communication: Azithromycin (Zithromax or Zmax) and the risk of potentially fatal heart rhythms, U.S. Food and Drug Administration
- FDA Statement regarding azithromycin (Zithromax) and the risk of cardiovascular death, U.S. Food and Drug Administration
- Popular Antibiotic May Raise Risk of Sudden Death, New York Times
- Azithromycin and the Risk of Cardiovascular Death, The New England Journal of Medicine
- FDA: Popular antibiotic can cause fatal heart rhythms, CNN.com