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Azithromycin Gets Tougher FDA Warning About Deadly Heart Rhythm Risk

A tougher warning instituted by the US Food and Drug Administration this week cautions that azithromycin, a commonly prescribed antibiotic, most certainly can cause modifications to the heart’s electrical activity, which can cause some users to develop a deadly irregular heart rhythm. The federal agency had modified the drug’s warning labels last year.

Azithromycin (also known as Z-Pak) was requested in 55.3 million prescriptions last year alone. It is made by Pfizer.

This more stringent warning comes following the FDA’s review of a study published in the Spring of 2012 in the New England Journal of Medicine. Per the study, taking azithromycin over five days appears to slightly increase the changes of death compared to in other patients that were taking other antibiotics. Some of these azithromycin users suffered fatal heart attacks, cardiac death, strokes, and other cardiovascular conditions.

According to the study’s lead author, Vanderbilt University Preventive Medicine Professor Wayne Ray, many physicians prescribe azithromycin rather than amoxicillin because the former’s regimen is easier, involving less pills over less days. This generally means that the patient is likely to take all the pills, decreasing his/her chances of getting a bug resistant to the antibiotic (Azithromycin is usually ingested over five days, while many other antibiotics must be taken for 10 days.)

However, Ray believes that the risk of dying surpasses any convenience for at-risk patients, which are usually the ones who suffer from some kinds of cardiovascular disease. The drug is typically prescribed to combat bacterial infections, such as pneumonia, bronchitis, ear aches, and sore throat.

Ray and his colleagues, who examined Medicaid patients from ’92 – ’06 and studied millions of prescriptions, determined that patients taking azithromycin were 2.5 times more likely to die from a cardiovascular condition while on the drug than patients taking the drug amoxicillin. Also among those at risk of developing a deadly irregular heart rhythm while taking azithromycin are older people and patients with low magnesium or potassium levels in their blood, those with slow heart rates, and people taking meds that tend to stretch out the gaps between heart beats.

The new revised label for azithromycin label now includes stronger warnings, details from Ray’s study, and data from a study conducted by Pfizer.

At Altman & Altman, LLP, our dangerous drug lawyers represent patients and their families with products liability claims against drug manufacturers, distributors, sellers, and other liable parties. In some instances, there may be more than one party to pursue damages from. For example, your physician may have disregarded FDA warnings that a drug was dangerous, so you could have a medical malpractice case cases not just against the drug maker but also your doctor. There is no warranted reason why your use of a medication should kill a loved one or cause you serious injury.


F.D.A. Raises Heart Alert on Antibiotic in Wide Use
, New York Times, March 12, 2013
FDA Drug Safety Communication: Azithromycin (Zithromax or Zmax) and the risk of potentially fatal heart rhythms, FDA, March 12, 2013

Azithromycin and the Risk of Cardiovascular Death, New England Journal of Medicine, May 17, 2012


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