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Azithromycin, the antibiotic sold as Zithromax or Zmax and commonly packaged as a “Z-Pak,” can cause a potentially fatal irregular heart rhythm, the U.S. Food and Drug Administration (FDA) says in a warning to health care professionals and consumers.
Azithromycin can cause changes in the electrical activity of the heart, which may lead to an irregular heart rhythm, or arrhythmia, the FDA says. Certain arrhythmias may increase the risk of heart failure and stroke.
Azithromycin (Zithromax / Zmax) is used to treat bacterial infections such as bronchitis, pneumonia, sexually transmitted diseases (STDs) and infections of the ears, lungs, sinuses, skin, throat and reproductive organs.
Patients at particular risk for developing irregular heart rhythm from using Zithromax or Zmax include those with:
- Known risk factors such as existing QT interval prolongation (an abnormal heart rhythm)
- Low blood levels of potassium or magnesium
- A slower-than-normal heart rate
- Use of certain drugs used to treat arrhythmias.
The FDA says it has updated the Warnings and Precautions section of azithromycin package labels with information about the risk of QT interval prolongation and torsades de pointes, a specific, rare heart rhythm abnormality. Information has also been added regarding the results of a clinical QT study that showed that azithromycin can prolong the QTc interval.
“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,” the FDA says.
Studies Identify Dangers with Zithromax, Zmax (Z-Pak)
The FDA warning about the link between the antibiotic azithromycin and irregular heart rhythms is based on studies published by the New England Journal of Medicine (NEJM) and by Pfizer, a manufacturer of the drug.
The NEJM reported in May 2012 that Vanderbilt University researchers examined the records of thousands of Tennessee Medicaid patients over a period of 14 years. They found a 2.5-fold higher risk of death from heart disease in the first five days of using Z-Pak when compared to another common antibiotic or no antibiotics at all.
Pfizer said following the FDA warning statement that the warning does not apply to the majority of patients treated with Zithromax / Zmax (azithromycin).
The five-dosage Z-Pak of Zithromax or Zmax has been popular as an alternative to other antibiotics, like amoxicillin, which require a 10-day regimen.
The FDA suggests patients consult their own doctors before discontinuing the use of the drug.
Contact a Birmingham Product Liability Lawyer Today
When manufacturers bring a medical product to market, they are legally obligated to provide a well-designed product that is reasonably safe when used as intended. Failure to do so can result in a legal claim of negligence on the part of the manufacturer and compensation for individuals who have been harmed.
Belt & Bruner, P.C., represents individuals and the families of those who have been seriously or fatality injured by unsafe medical products. The firm has recovered millions of dollars in damages for clients across Alabama.
If you or a loved one has had a severe adverse reaction to using Zithromax or Zmax (azithromycin), call us today at (888) 920-3251 or fill out our online form to learn more about how we can help you to protect your legal rights and recover the maximum compensation possible.
For More Information
- FDA Drug Safety Communication: Azithromycin (Zithromax or Zmax) and the risk of potentially fatal heart rhythms, U.S. Food and Drug Administration (FDA)
- FDA Statement regarding azithromycin (Zithromax) and the risk of cardiovascular death, (FDA)
- Azithromycin and the Risk of Cardiovascular Death, The New England Journal of Medicine
- FDA: Popular antibiotic can cause fatal heart rhythms, CNN.com
- Popular Antibiotic May Raise Risk of Sudden Death, New York Times