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Zithromax May Cause Fatal Heart Rhythm, FDA Warns
By Courtney Coren
The U.S. Food and Drug Administration dealt a major blow this year to Zithromax and Zmax maker Pfizer Inc. when the federal regulatory agency announced that the popular azithromycin based antibiotics came with the risk of causing potentially fatal heart rhythms.
“[The 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,” said the safety announcement.
The FDA is recommending that doctors should consider other antibiotics for patients that already have heart conditions, for they are at greater risk for this side effect.
“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 FDA added.
The announcement was the result of a study conducted by researchers at Vanderbilt University and a study done by Zithromax maker Pfizer Inc.
The Vanderbilt University study was published in the New England Journal of Medicine in May 2012. The study showed a 250 percent higher chance of dying from a cardiovascular event within the first five days of taking Zithromax compared with those who took the antibiotic amoxicillin.
They looked at Tennessee Medicaid patient records from 1992 to 2006 and compared around 348,000 prescriptions of Zithromax compared with millions of prescriptions from other commonly prescribed antibiotics–primarily amoxicillin, which is prescribed for similar reasons as Zithromax.
Even though the number of deaths was very low, they found 47 more deaths per million among the group who were taking Zithromax. If the patient already had heart problems, the risk for cardiovascular death increased to 245 additional deaths per million.
The conclusion was that doctors need to take into account the risks of the patient before choosing which antibiotic to prescribe.
The study was conducted by Wayne A. Ray, Ph.D., a professor of Preventative Medicine, and C. Michael Stein, M.B., Ch.B., the Dan May Chair in Medicine and professor of Pharmacology — both at Vanderbilt University. They also concluded that although the risk is rare, it is still significant.
“We believe this study adds important information on the risk profile for azithromycin,” Ray said. “For patients with elevated cardiovascular risk and infections for which there are alternative antibiotics, the cardiovascular effects of azithromycin may be an important clinical consideration.”
Zithromax and other versions of the drug such as Z-Pak, Zmax, and azithromycin (the generic version of the drug) are popular antibiotics prescribed for treating bacterial sinus infections and bronchitis due to the fact that patients only have to take the drug for five days as opposed 10 to 15 days for traditional antibiotics such as amoxicillin.
If you or someone you know has suffered from a heart attack or stroke after taking Zithromax, legal options are available to you. Learn more and get a free legal consultation regarding a claim’s eligibility at the Zithromax Z-Pak Azithromycin Class Action Lawsuit Settlement Investigation. Experienced legal professionals have access to medical experts to assess whether or not this antibiotic played a role in your heart attack or stroke, so act now.
All medical device, dangerous drug and medical class action and lawsuit news updates are listed in the Drug and Medical Device section of Top Class Actions.
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