FDA Warns Popular Antibiotic May Cause Cardiac Death

Zithromax is one of several trade names for azithromycin, a broad-spectrum antibiotic. It also sells as the Z-Pak, Zithromax and Zmax. The drug is effective against a great variety of bacteria, and usually does not cause problems for patients with penicillin allergies, making it a useful alternative. However, the drug may cause serious problems in other vulnerable patients.

The United States Food and Drug Administration or FDA issued a statement in May of 2012 in response to a published study. The study was published in the prestigious New England Journal of Medicine the same month. The study was an epidemiological review, which found an elevated risk of certain types of abnormal hearth rhythms like prolongation of the QT interval connected to Zithromax use.

This abnormal rhythm can cause a heart to hydraulically lock itself, causing cardiac arrest. The statement warned physicians to take this into account when prescribing Zithromax. However, the statement specifically told patients not to discontinue their antibiotics without consulting a physician, since improper antibiotic use can cause problems in and of itself.

Then, in March of this year, the FDA issued a more serious statement. This coincided with updated Zithromax side effects labeling for the drug.

The new Drug Safety Communication explained the updated warnings for Zithromax labeling. The new statement also mentioned that the Zithromax heart problems were most likely to occur in patients with existing heart problems like preexisting abnormal heart rhythms. This updated information was based on a through review of both the New England Journal of Medicine study and studies by the manufacturer that found similar results.

Numerous Zithromax lawsuits have been filed against the manufacturer of the drug, Pfizer. These lawsuits allege that Pfizer was aware – or reasonably should have been aware – of the risk of serious Zithromax side effects.

These Zithromax lawsuits further allege that Pfizer failed to act on this information in a timely manner, preventing patients and their prescribing physicians from having all of the information they needed to make informed decisions regarding their medical care. Plaintiffs in these Zithromax injury lawsuits seek damages related to medical costs, lost wages, and in some cases, wrongful death.