New Zithromax Arrhythmia and Sudden Death Cases Allegations Report: Manufacturer Updates Labeling to Reflect Possible Heart Abnormalities
San Diego, CA (PRWEB) July 12, 2013 -- http://www.resource4thepeople.com/defectivedrugs/Zithromax-lawsuits.html
Resource4thePeople announced today that it is urging consumers to familiarize themselves with the possibility of negative side effects from popular medications.
The announcement comes as Resource4thePeople reports an increased number of inquiries into the safety of the popular antibiotics Zithromax and Zmax SR (azithromycin) amid allegations of life-threatening irregular heart rhythms.
“We are alerting consumers that the medications’ manufacturer, Pfizer, has now posted* an announcement about arrhythmia side effects on its web site,” said Resource4thePeople. “We encourage all consumers to completely review the side effects of Zithromax or any other medication that they may be using.
“In addition to offering this information our national network of attorneys will continue to provide free consultations about legal rights available to an increasing numbers of consumers over allegations that they suffered serious heart problems as a result of these medications.”
Resource4thePeople also announced that it has received an overwhelming positive response to the information center it created to inform consumers about the latest information involving legal rights over allegations that Zithromax and Zmax SR (azithromycin) can cause potentially fatal irregular heart rhythms.
“The more information that consumers have about the medications they are prescribed the more informed the decision they can make about drugs that can have serious effects on their health,” said Resource4thePeople.
The information site also has easy-to-follow links to free consultations for consumers seeking to determine what legal rights they may have to compensation in such cases in the wake of a May, 17, 2012 warning** issued by the U.S. Food and Drug Administration.
“These are serious health concerns that the FDA has addressed and we will continue to provide valuable information of interest to consumers who may be among the millions who have been or are considering being treated with these antibiotics,” said Resource4thePeople.
“The postings on this site also will include detailed information about who the FDA considers most at risk of suffering these dangerous side effects.”
The FDA, in the warning, provided information to patients and physicians about possible life-threatening side effects from the medications that may lead to irregular heart rhythms.
Consumers also should be aware that there may be legal time limits involved in the filing of a Zithromax lawsuit over allegations of serious side effects and early consultations about their status are recommended.
Antibiotics are among the most prescribed medications and azithromycin is most commonly chosen by doctors to treat a variety of bacterial infections. The medications are most frequently used for bronchitis, pneumonia, chest infections, urinary tract and other common infections.
Canadian authorities have joined the FDA in issuing warnings about concerns that the use of these antibiotics may cause abnormal changes in the electrical activity of the heart.
The Canadian Broadcasting Company reported*** on May 17, 2013 that Health Canada has issued a warning that a "small absolute increase in the risk of cardiovascular deaths was observed in patients taking azithromycin as compared to those who took no antibiotics and those who took amoxicillin in a recent study."
The FDA warning and a study published the same day in a respected medical journal**** cited concerns about whether patients who use the medications are at higher risk of suffering cardiac problems.
FDA officials said that they had been made aware of the study published in the New England Journal of Medicine in which medical researchers found a higher percentage of cardiovascular deaths among patients treated with azithromycin (Zithromax) than with other antibiotics or no drugs.
The FDA announced that it is reviewing the findings of this study and said it will inform health care professionals and consumers about the results of this review after its completion.
The FDA also passed on this information about the review and ordered updated warnings on the medication’s labels about health risks:
“Azithromycin belongs to a class of antibacterial drugs called macrolides, which have been associated with cardiovascular effects; specifically, prolongation of the QT interval. In 2011, FDA reviewed macrolide drug labeling information related to QT interval prolongation and TdP.
“The WARNINGS AND PRECAUTIONS section of the Zmax drug label (azithromycin extended release for oral suspension) was revised in March 2012 to include new information regarding risk for QT interval prolongation, which appears to be low.
“The drug labels for clarithromycin and erythromycin also contain information about QT interval prolongation in the WARNINGS section. FDA is in the process of updating risk information in the drug labels for additional macrolide antibacterial drugs.”
The FDA also recommended that patients who are taking azithromycin should not stop taking their medicine without talking to their health care professional and that physicians “should be aware of the potential for QT interval prolongation and heart arrhythmias when prescribing or administering macrolides.”
“In its Safety Information Report the FDA also encouraged patients and health care professionals to report adverse events or side effects caused by the use of these medications to the agency,” said Resource4thePeople.
The New England Journal of Medicine study included research compiled from information accumulated from about 350,000 patients who were treated with azithromycin over a 15-year period and concluded that these patients were one and a half times more likely to suffer cardiovascular sudden death than patients treated with other antibiotics.
One of the factors that made Zithromax so popular was the fact that it could be taken as a five-day treatment while most other antibiotics are prescribed to be taken over a 10-day treatment plan.
SOURCES:
**http://www.fda.gov/Drugs/DrugSafety/ucm304372.htm
***http://www.cbc.ca/news/health/story/2013/05/16/azithromycin-heart.html
**** http://www.nejm.org/doi/full/10.1056/NEJMoa1003833
Bill Callahan, iLawSuit, 858 602-2749, [email protected]
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