Zithromax Z-pak Warnings Issued by FDA

The U.S. Food and Drug Administration (FDA) has ordered Pfizer to update the Zithromax Z-pak Warnings label for the widely used antibiotic Zithromax after researchers foundd that the drug can increase the risks of potentially fatal irregular heartbeats.

FDA-Z-Pak-Safety-Warning-Fatal-Heart-Rhythm-Cochran-Firm-OhioPfizer’s popular antibiotic azithromycin, sold as Zithromax, Z-pak, and Zmax, often prescribed by physicians to treat bacterial infections like sinus infections, strep throat, bronchitis, and urinary tract infections, has been determined to cause a potentially fatal change in the electrical activity in the heart, altering the rhythm of heartbeats, and creating an increased risk of death among certain patients. In fact, researchers published a study in the New England Journal of Medicine last May which found an increased risk of cardiovascular death in patients who took Zithromax over other types of antibiotics like amoxicillin and ciprofloxacin, as well as others. (https://abclocal.go.com/wpvi/story?section=news/health&id=9017679)

Z-Pak Symptoms

According to Reuters, the FDA announced Z-pak increases the risk of prolonged QT interval, which is a potentially fatal condition where the contractions of the heart become irregular. The FDA said that physicians should practice caution when prescribing the antibiotic to certain at-risk patients including the elderly and those with:

  • Below normal levels of magnesium or potassium
  • Abnormal heart rhythms
  • Arrhythmias
  • Low heart rate
  • A rare condition known as torsades de pointes

FDA Safety Information

The FDA is urging patients not to stop taking Z-Packs without speaking first to their physicians, and that if a patients is currently using Zithromax and experiences the following symptoms they should seek medical attention immediately.

  • Dizziness
  • Shortness of breath
  • Fainting
  • Irregular heartbeat

The federal agency also recommended in a statement that “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.,”

Pfizer issued an email statement saying that “The majority of patients treated with Zithromax (azithromycin) are not affected by this label update.” The company said Zithromax “has had a well established benefit risk profile for more than 20 years and continues to be an effective treatment option for patients all over the globe suffering from many types of bacterial infections.”( https://www.bloomberg.com/news/2013-03-12/heart-warning-added-to-pfizer-s-z-pak-antibiotic-by-fda.html)

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