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Published: March 12th, 2013
Side effects of Zithromax, which is also known as Z-Pak or generic azithromycin, has been linked to an increased risk of heart-related death and abnormal heart rhythms, leading to question about the safety of the popular antibiotic.
STATUS OF ZITHROMAX Z-PAK LAWSUITS: Product liability lawyers are evaluating the potential for Zithromax lawsuits on behalf of individuals who have died as a result of abnormal heart rhythms or other heart problems after using the medication.
MANUFACTURER: Pfizer, Inc., but also available as generic azithromycin.
OVERVIEW: Zithromax (azithromycin) was first approved in the U.S. by the FDA in 1991. It is a commonly used antibiotic for treatment of respiratory infections, urinary tract infections, tonsillitis and other bacterial infections. The medication generated sales of more than $450 million for Pfizer in 2011, and is available as a generic.
The antibiotic is part of a class of antibacterial medications known as macrolides, which have been known to cause abnormal heart rhythm problems and Zithromax may increase the risk of fatal heart problems compared to other antibiotics.
ZITHROMAX Z-PAK HEART SIDE EFFECTS: In 2011, the FDA reviewed Zithromax and other macrolides for links to abnormal heart rhythms, including QT interval prolongation. The alterations in heart rhythm can lead to a fatal condition known as torsades de pointes.
Following the FDA investigation, the Zithromax warning was updated, along with all macrolides, to indicate that patients and doctors should be aware of potential heart rhythm problems.
In May 2012, a study was published in the New England Journal of Medicine, which evaluated records involving more than 347,000 patients who took Zithromax or a generic equivalent, 1.4 million who took no antibiotics, 1.3 million who took amoxicillin, 264,000 who took Cipro and 264,000 given Levaquin.
Researchers found that Zithromax side effects may increase the risk of death, with 2.5 times as many patients dying from heart problems during the five days of treatment than while taking amoxicillin.
Although the absolute increase in cardovascular death from Zithromax was small, it was most prominent among individuals with a risk of cardiovascular disease. According to the study, there are 47 more deaths for every million people who took Zithromax over amoxicillin, but that number jumps to more than 245 deaths among those at risk for heart problems.
Some experts have indicated that Zithromax Z-Pak should not be given to patients already known to have heart problems.
Following the May 2012 study in the New England Journal of Medicine, the FDA initiated a review of the potential Zithromax heart risks.
According to a safety communication provided in March 2013, the FDA determined that the Zithromax warning label will be updated to provide additional information regarding the risk of QT interval prolongation and torsades de pointes. The agency cautioned that individuals prescribed a Z-Pak or azithromycin therapy should not stop taking their medication without first speaking with their doctor.
FIND OUT IF YOU MAY QUALIFY FOR A ZITHROMAX LAWSUIT: As a result of the drug makers’ possible failure to adequately warn about the risks associated with their medication, Zithromax lawyers are evaluating whether users may be entitled to compensation through a product liability lawsuit.