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Z Pack Warning Released by FDA about Popular Antibiotic

Z Pack Warning 2013If you've been to the doctor in the last 10 years for a sinus infection, you've probably ran across the brand name, "Z Pack." This wonder antibiotic licensed and sold by Pfizer has become so well-known that doctors often find patients asking for a Z Pack by name. The antibiotic drug is also well known under it's other pharmacy labels with names like Azithromycin Zpack, Zithromax Z packs & Zmax.

On Tuesday March 12th, 2013 the FDA released some more information on possible problems with Z Pack causing fatal heart rhythms in some patients. The FDA release started with the statement that, "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."

The most updated information was released by the FDA and Pfizer has had to update & strengthen their warnings and precautions because of a medical studies. A clinical study confirmed previous research that the azithromycin drug could be affecting patient heart rates in a profound way that could cause death. The alert from the FDA this time is directed not only towards patients that may want to request a Z Pack for treatment of their infections but to health care professionals.

The FDA Statement said 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 (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."

Surprisingly to many, this isn't new information since clinical studies and research projects had found that patients who took a 5 day course of Zirthromax compared to patients that had been treated with things like amoxicillan, ciprofloxacin, or no drugs at all had higher rates of cardiovascular death. One large study that was referenced by the FDA on May 17th, 2012 was the New England Journal of Medicine study.

Right before the FDA released their May 17th warning the New York Times covered the potential problems of the drug with a story titled, "Popular Antibiotic May Raise Risk of Sudden Death." At the time of the NYT Times Z Pack story the facts and figures of the economic results of Pfizer's Z-Pak sales were about $464.6 million dollars a year. The number of prescriptions handed out by doctors in 2011 for Z Paks were around 55.3 million. Global sales of the popular antibiotic were sitting around $1.8 billion dollars and all figures have only grown since those last reports.

The growth has been quite large since Pfizer licensed the rights to exclusively sell azithromycin in Western Europe and The United States. The deal was signed by Pfizer and Pliva in 1986 after the drug was patented by Pliva in 1981 shortly after its discovery in 1980. There have been more uses invented for the drug azithromycin after the FDA approved it for the treatment of eye infections with AzaSite marketed by Merck. The most common use consumers should be concerned with of the popular antibiotic is under the Zithromax, Z-Pak and Zmax brands.

Consumers, patients, parents and people concerned about the effects of Azithromycin on their health should know their family heart history before requesting the drug. Other medical problems like low potassium and magnesium levels were also reported as issues and heart rhythm in patients when taking a Z Pak. The antibiotic is still America's antibiotic of choice but patients definitely need to be careful when considering it, especially if there are heart problems that run in your family.

New Heart Warning for Popular Z-Pak Antibiotics

FDA: 'Z-pack' antibiotics could cause deadly heart problems

Z-Pak antibiotic dangerous for people with heart conditions

A commonly-used antibiotic is now being held responsible for an increase in heart related deaths.

According to research out of Vanderbilt University in Nashville, TN, heart-related deaths among people taking Z-Pak is up 2.5 percent. Though the number may be small, East Texas doctors say the risk isn't worth it.

Zithromax Lawsuit

If you or a loved one experienced Zithromax (Z-Pak) sudden cardiac death or heart arrhythmia resulting in hospitalization following treatment with Zithromax, you may be able to file a lawsuit seeking compensation for your injuries.

Our Zithromax lawyers and attorneys at can help you seek compensation for medical expenses, pain and suffering, lost wages, and other injuries. We have extensive litigation experience and have recovered billions of dollars for our clients. In addition to being staunch advocates for your claim, we provide personal attention to guide you through the complex litigation process.

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2 Responses »

  1. And they still call marijuana a dangerous drug even though it's never killed anyone.

  2. How long after one stops taking Z-Pak, does this effect last?