FDA Issues Z-Pak Safety Warning: Risk Of Fatal Heart Rhythm

  • Post category:March 2013

FDA Issues Z-Pak Safety Warning: Risk of Fatal Heart Rhythm

The U.S. Food and Drug Administration (FDA) has issued Z-Pak safety warnings for Pfizer’s Z-Pak, Zmax, and Zithromax.


Drug giant Pfizer has been ordered by the U.S. Food and Drug Administration (FDA) to change the warning labels for the antibiotic azithromycin to include the increased risk of potentially fatal heart rhythm changes.

When researchers published a study last May in the New England Journal of Medicine finding that azithromycin, also sold as Z-Pak, Zmax, and Zithromax, carried and increased risk of cardiovascular death over other types of common antibiotics like cipro and amoxicillin, the U.S. Food and Drug Administration paid close attention.

Zithromax, is widely prescribed to treat common bacterial infections like bronchitis, urinary tract infections, sinus infections, and strep throat. It gained in popularity because it generally works faster than other antibiotics and the length of treatment is shorter, generally five days. However, the 14-year study found that patients on Zpak had a 2.5-fold increase of suffering a cardiovascular related death while taking the drug, then those patients who used other antibiotics. According to Harvard Heath, certain patients had an even higher risk of suffering a fatal cardiovascular event. These patients includes those with:

  • Heart failure
  • Previous bypass surgery
  • Stents
  • Previous heart attack
  • diabetes

According to the FDA, Zithromax can cause a potentially fatal change in the rhythm of the heart, known as a prolonged QT interval. The federal agency recommends that physicians carefully consider prescribing the medication to certain groups, including the elderly and those with

  • Low heart rate
  • Arrhythmias/li&gt
  • Abnormal heart rhythms/li&gt
  • Low levels of potassium or magnesium/li&gt
  • Torsades de pointes/li&gt

Reuters reports that the FDA is also warning patients to speak to their healthcare providers before stopping taking Zmax, Zpak, or Zithromax, and to seek medical attention immediately if they experience the following symptoms while taking the medication:

  • Shortness of breath/li&gt
  • Fainting/li&gt
  • Dizziness/li&gt
  • Irregular heartbeat/li&gt

Bloomberg reports that Pfizer issued an email statement saying “The majority of patients treated with Zithromax (azithromycin) are not affected by this label update.” The company also 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.”

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