Atrial Fibrillation Rx Alert

Heart arrhythmia guidelines enhanced after PALLAS trial

/ Author:  / Reviewed by: Joseph V. Madia, MD

(RxWiki News) Last month the PALLAS trial revealed adverse cardiovascular risks in taking dronedarone (Multaq) for irregular heart beat. Now the European Society of Cardiology is suggesting its use be limited.

The PALLAS trial investigated the safety and efficacy of dronedarone in a randomized placebo trial in patients over the age of 65 with permanent atrial fibrillation, a common heart arrhythmia.

"Talk to your cardiologist about medication options."

The trial was terminated early because of adverse cardiovascular outcomes associated with the drug. Early study results had shown that the drug caused an increased risk of cardiovascular death, stroke, heart failure hospitalization, heart attack and systemic arterial embolism. Study results are still being reviewed and are not yet finalized.

As a result of the study, both the U.S. Food and Drug Administration and the European Medicines Agency reminded doctors to take care in prescribing the medication, and to avoid giving it to those with permanent atrial fibrillation.

Current ESC guidelines recomend the use of dronedarone in patients with atrial fibrillation as an antiarrhythmic agent, to prevent its recurrence and to reduce ventricular rate in patients without permanent atrial fibrillation.

The agency is now strongly advising against prescribing the medication in patients who have had heart failure within the past month. The ESC also reaffirmed that the drug should not be given to patients with permanent atrial fibrillation. There are no suggested changes in taking the drug for those with non-permanent atrial fibrillation or those with atrial flutter.

Both the EMA and FDA are currently reviewing the risks and benefits of dronedarone and are expected to issue new regulations regarding the drug.

Previously the ESC had said patients should not stop taking the drug without first consulting their physician. FDA officials also recommended speaking to a doctor about any concerns about the medicine.

Reviewed by: 
Review Date: 
August 8, 2011
Last Updated:
August 11, 2011