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How important are Z-Pak side effects to you, kids and family members?

Are Z-Pak cardiovascular and stevens johnson syndrome risks real?

The New England Journal and the FDA evaluating the Z-Pak cardiovascular and stevens johnson syndrome risks.

Z-Pak Antibiotic Raises Death Risk for Some, Says Study


Patients prescribed the antibiotic azithromycin are more likely to die than those prescribed a different antibiotic, according to a study published in the New England Journal of Medicine on Wednesday.

These results were especially pronounced for those who died from heart attacks, strokes, sudden cardiac death and other cardiovascular causes.

Last year, doctors wrote 55.3 million prescriptions for Azithromycin, commonly known by the trade name Z-Pak,  according to IMS Health. Like the popular antibiotic amoxicillin, azithromycin is commonly prescribed to help fight off bacterial infections.

But while they are often prescribed for similar conditions, the two drugs work differently from each other.

Wayne Ray, professor of preventive medicine at Vanderbilt University, in Nashville, Tenn., and lead author of the study, says he thinks many doctors prescribe azithromycin instead of amoxicillin because of its easier regimen; patients on azithromycin take fewer pills over fewer days, which means they are more likely to finish their entire course of medicine.

 z-pak azithromycin

Zithromax Z-Pak Risk

NEJM Study

Researchers studied the relationship between various antibiotics and cardiovascular deaths among 540,000 Tennessee Medicaid patients aged 30 to 74 from 1992 to 2006.

The study analyzed 350,000 Zithromax Z-Pak prescriptions, 1.4 million amoxicillin prescriptions, 265,000 prescriptions for ciprofloxacin (Cipro) and 194,000 for levofloxacin (Levaquin); 1.4 million cases of non-treatment were also taken into account. Overall, it was found that Zithromax Z-Pak exhibited 64.6 deaths per million courses, compared to 21.8 for amoxicillin and 24 for non- treatment.

Lead author Dr. Wayne A. Ray said that the risk was greatest among patients who have or are at high-risk for heart disease, including:

  • Patients with heart failure or have had a previous heart attack
  • Patients with diabetes
  • Patients who have undergone bypass surgery
  • Patients who have stents implanted

FDA Response

The U.S. Food and Drug Administration (FDA) has acknowledged the study in a Safety Alert, and “is reviewing the results from this study and will communicate any new information on azithromycin and this study or the potential risk of QT interval prolongation after the agency has completed its review.” For now, the agency has not recommended any further action.


'Z-Pack' Antibiotic Sudden Death Risk | Video - ABC News

May 17, 2012 - 2 min
Common treatment for sore throats and sinus infections linked to heart risk.
Stevens-Johnson Syndrome (SJS) issue to determine the need for any Z-Pak Cardiovascular death regulatory action.

The appearance of a drug like Z-Pak on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but does not mean that FDA has identified a causal relationship between the drug and the listed risk.

If after further evaluation the FDA determines that the drug Z-Pak is associated with the risk, it may take a variety of actions including requiring changes to the labeling of the drug, requiring development of a Risk Evaluation and Mitigation Strategy (REMS), or gathering additional data to better characterize the risk.

FDA wants to emphasize that the listing of a drug Z-Pak and a potential safety issue on this Web site does not mean that FDA is suggesting prescribers should not prescribe the drug or that patients taking the drug should stop taking the medication.

Patients who have questions about their use of the identified drug Z-Pak should contact their health care provider. FDA will complete its evaluation of each potential signal/new safety information and issue additional public