Zithromax Arrhythmia and Sudden Death Allegations and Antibiotics Help: Resource4thePeople Reports Concerns about Overprescribing Drugs

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Media health report cites problems with prescribing of antibiotics such as Zithromax by physicians. Resource4thePeople announces it will continue to provide free legal consultations about rights to legal compensation over allegations of dangerous side effects from the use of Zithromax and Zmax SR.


Resource4thePeople announced today its latest update for consumers keeping abreast of the dangers of negative side effects from popular antibiotics such as Zithromax and Zmax SR.

The most recent news comes in the form of a report* in the Wall Street Journal warning that doctors are overprescribing antibiotics and in some cases prescribing the wrong ones.

The report in the Aug. 9, 2013 edition of the Wall Street Journal said that overuse or misapplication of antibiotics can make the medications less effective and also wipe out the body's good bacteria.

"Professional organizations, including the American Academy of Pediatrics, and public-health groups such as the Centers for Disease Control and Prevention are pushing doctors to limit the use of broad-spectrum antibiotics," the Journal reported.

"Among the most common broad-spectrum antibiotics are ciprofloxacin and levofloxacin—a class of drugs known as fluoroquinolones—and azithromycin, which is sold by one drug maker under the brand name Zithromax, or Z-Pak."

Resource4thePeople also is informing consumers that other, more serious side effects have been attributed the antibiotics.

In a May, 17, 2012 warning** issued by the U.S. Food and Drug Administration agency officials provided information to patients and physicians about possible life-threatening side effects from the medications that may lead to irregular heart rhythms.

"As the FDA warned, serious heart problems and incidents of sudden death have been reported to the agency through its adverse event reporting program," said Resource4thePeople.

"Our national network of lawyers has been reviewing claims that we have been receiving from patients who are raising allegations of serious health problems they attribute to the use of Zithromax and Z-Pak."

Resource4thePeople is announcing that it will continue to offer free consultations to consumers who are seeking information about what legal options they may have to seek compensation for medical costs, loss of wages, pain and suffering and other related expenses.

"In addition to announcing the continuation of these consultations we will also continue to provide updates about new developments involving these medications," said Resource4thePeople.

Among the most recent developments is the FDA's action in sending a strongly worded warning letter*** 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.

"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 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."

FDA regulators also found 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.

“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.

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."

***** http://www.nejm.org/doi/full/10.1056/NEJMoa1003833

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