RationalMed and FDA Warn of Fatal Heart Rhythms

Aug 8, 2013
The FDA just bolstered label warnings for azithromycin due to cardiac arrhythmias. Express Scripts' RationalMed has alerted MDs of the risk for over a year.

Yesterday, the U.S. Food and Drug Administration (FDA) announced it will strengthen the warnings and precautions sections of the label for the widely used antibiotic azithromycin (Zithromax®, Zmax®), based on a potential risk of life-threatening irregular heart beat, or cardiac arrhythmias.

The formulation known as Z-Pak, a 5-day course of azithromycin typically prescribed for common bacterial infections, such as bronchitis, sinusitis or strep throat, is extremely popular.

Patients with risk factors such as QT prolongation on EKG, bradycardia (slow heart rhythm), and low blood levels of magnesium or potassium are at particular risk.

The FDA action follows publication of a study in the New England Journal of Medicine (NEJM) in May 2012 in which researchers reported a nearly two-fold higher risk of cardiovascular death in patients taking azithromycin versus amoxicillin or no antibiotics. An additional study by the manufacturer demonstrated that azithromycin prolongs the QT interval.

Per the FDA warning, healthcare professionals should consider the risk of fatal heart rhythms with azithromycin in patients with pre-existing cardiovascular conditions.

RationalMed: Actionable Data Helps High-Risk Patients

Even before the FDA warning, Express Scripts’ RationalMed® has been helping physicians and protecting patients from this potentially fatal side effect of azithromycin and similar antibiotics. For nearly a year since the publication of the NEJM study on which the FDA action was based, RationalMed has been alerting physicians who prescribe azithromycin to patients at risk for fatal heart rhythms and warn them of the potential risk, resulting in a therapy change more than 75% of the time.

Patients often see multiple doctors for different conditions. It’s quite possible for a physician to prescribe medication for a patient and not know that the patient could have a drug-disease interaction. RationalMed reduces that risk by using integrated pharmacy and medical data to identify patients at risk and then alerts physicians to potential issues.
Patients can protect themselves, too, by making sure they disclose their full medical history and current list of medications to every doctor they see.

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