Zithromax lawsuits are being investigated by Bernstein Liebhard LLP in the wake of a new warning on March 12, 2013 from the U.S. Food & Drug Administration (FDA) regarding potentially fatal irregular heart rhythms that can occur among patients taking the antibiotic Zithromax, known popularly as Z-Pak, and also sold under the brand name ZMax. The new warning was prompted by an FDA review of two studies that assessed the potential for Zithromax to cause abnormal changes in the electrical activity of the heart. One study, published in the New England Journal of Medicine in May 2012, reported a higher risk of cardiovascular deaths and deaths from any cause in persons treated with a 5-day course of Zithromax compared to those treated with amoxicillin. The estimated excess risk of cardiovascular death compared with amoxicillin ranged from roughly 1 in 111,000 among healthier patients to 1 in 4,100 among those with certain cardiovascular risk factors. The FDA also reviewed a second study that assessed the potential for Zithromax to cause abnormal changes in the electrical activity of the heart. That study determined that Zithromax can lead to a potentially fatal heart rhythm known as prolonged QT interval, in which the timing of the heart’s contractions becomes irregular.
The FDA said in its Safety Communication that the Warning and Precautions Section of the Zithromax label would be updated with stronger language regarding the risk of life-threatening irregular heart rhythms. The agency also noted that certain risk factors may increase the likelihood an individual will suffer a heart rhythm disturbance while using Zithromax, including:
- QT interval prolongation
- Low blood levels of potassium or magnesium
- Slower than normal heart rate
- Use of certain drugs used to treat abnormal heart rhythms, or arrhythmias
If Zithromax caused the sudden death of someone you loved, or you developed heart arrhythmia resulting in hospitalization following treatment with Zithromax, contact our Zithromax lawyers today for a free case review. You may be eligible to file a Zithromax lawsuit seeking compensation for:
- Medical expenses
- Lost wages
- Pain and suffering
- Permanent disability cost
- Out-of-pocket expenses
Z-Pak Increased Death Link
Zithromax was approved by the FDA in 1991. In the last two decades, it has become one of the most popular antibiotics, given that patients need only take the drug for a short period of time compared to other types of antibiotics. For example, in 2011, 55.3 million Zithromax prescriptions were written in the United States, amounting to sales of $464.6 million. Zithromax (azithromycin) is most often prescribed to treat common bacterial infections, such as bronchitis, pneumonia, sore throats, and earaches. Given that Zithromax is one of the most widely prescribed drugs, its potentially fatal side effects should not be taken lightly.
In addition to an abundance of media coverage by multiple news outlets following the NJEM report in May 2012, the FDA issued a statement at that time announcing the agency’s plans to review the study’s findings on whether Zithromax (azithromycin) puts patients at an increased risk for sudden death as well as heart arrhythmia. According to the study, individuals who are especially at risk for sudden cardiovascular death while taking Zithromax include those suffering from diabetes, heart failure, as well as patients who have undergone bypass surgery, sustained a previous heart attack; or have had cardiac stents implanted. The warning issued in March 2013 was, in part, the result of that review.
During an interview with NBC Nightly News last year, Dr. Wayne Ray, professor of preventative medicine at Vanderbilt University and lead author of the NEJM study, commented “There’s a lot of smoke with regard to whether or not there are heart problems and we wanted to see if there any fire. And we found that there was.”
Azithromycin belongs to a class of antibacterial drugs called macrolides. In 2011, the FDA reviewed all macrolides, including azithromycin and determined that macrolides, including Zithromax, were associated with prolonged cardiac repolarization and QT interval, imparting a risk of developing cardiac arrhythmia and torsades de pointes (“TdP”). As a result of that review, in March 2012, the Warnings and Precautions section of the Zmax (azithromycin extended release for oral suspension) drug label was revised to include abnormal heart rhythms as one of the side effects of Zithromax. The lawyers at Bernstein Liebhard LLP are carefully monitoring developments regarding these side effects and will communicate any new information and findings that may result.
Questions About Bringing A Zithromax (Z-Pak) 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. The Zithromax lawyers at Bernstein Liebhard LLP 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. To learn more about filing a Zithromax lawsuit, please call Bernstein Liebhard LLP at 1-877-779-1414 today.