Zithromax Arrhythmia and Sudden Death Cases Allegations Update: Resource4thePeople Reports FDA Issued Warning Letter to Manufacturer over False and Misleading Information

San Diego, CA (PRWEB) August 08, 2013

http://www.resource4thepeople.com/defectivedrugs/Zithromax-lawsuits.html

Resource4thePeople announced today its latest update for consumers seeking information about the possibility of life-threatening negative side effects from popular antibiotics Zithromax and Zmax SR as outlined by the Food and Drug Administration.*

The latest information involves a strongly worded warning letter** sent to the medications' manufacturer, Pfizer Inc., over language federal officials described as "false" and "misleading" in a brochure that the company sent out promoting the antibiotics.

The contents of the June, 19, 2012 letter were found during a recent check of FDA records by Resource4thePeople, whose national team of attorneys are offering free consultations to consumers who allegedly suffered serious heart problems from the use of the antibiotics.

"This warning letter from high-ranking FDA officials calls into question the honesty and marketing methods of Pfizer in promoting medicines that the FDA earlier had warned consumers and health care professionals about over life-threatening heart problems," said Resource4thePeople.

"In addition to announcing these free consultations about possible legal options to seek compensation for the loss of a loved one, medical costs, loss of wages, pain and suffering and other expenses, Resource4thePeople also will continue to provide updates about new developments involving these medications."

In its warning letter the FDA criticized a brochure issued by Pfizer for the medications and made the following finding:

"The brochure is false or misleading because it omits and minimizes important risk information, makes unsubstantiated superiority claims, omits material facts, broadens the indication for the drug product, makes misleading efficacy claims, and makes unsubstantiated claims for Zmax. Therefore, the brochure misbrands the drug in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 352(a); 321(n). Cf. 21 CFR 202.1(e)(5)(i) & (iii); (e)(6)(i) & (ii); (e)(7)(i) & (viii)."

FDA regulators also found in the warning letter that the brochure omitted important information that should have warned consumers about the risk of serious heart problems:

"Specifically, the brochure omits the important risk of QT prolongation associated with Zmax use. The WARNINGS AND PRECAUTIONS section of the PI states, “[p]rolonged cardiac repolarization and QT interval, imparting a risk of developing cardiac arrhythmia and torsades de pointes, have been seen in treatment with other macrolides. A similar effect with azithromycin cannot be completely ruled out in patients at increased risk for prolonged cardiac repolarization” (emphasis in original). By omitting this serious risk associated with Zmax, the brochure misleadingly suggests that the drug is safer than has been demonstrated."

Resource4thePeople notes that since the warning Pfizer has posted*** an announcement about arrhythmia side effects on its web site,” said Resource4thePeople.

“With both the FDA and Pfizer now informing the public about the dangers of arrhythmia we encourage all consumers to completely review the side effects of Zithromax or any other medication that they may be using," said Resource4thePeople.

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 heart problems.

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 the May, 17, 2012 warning* issued by the U.S. Food and Drug Administration.

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.

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 also passed on this information about the review and ordered updated warnings on the medication’s labels about health risks:

“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 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.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM310527.pdf
***http://www.pfizer.com/news/zithromax.jsp
**** http://www.nejm.org/doi/full/10.1056/NEJMoa1003833