The FDA is currently reviewing data from the PALLAS (Permanent Atrial FibriLLAtion outcome Study using dronedarone on top of standard therapy) clinical trial. The PALLAS Phase IIIb clinical trial has been discontinued, following an increased incidence of cardiovascular events in patients receiving the drug. In the study, dronedarone was used in patients with permanent atrial fibrillation (AF). Currently, it is approved for use in non-permanent AF and has a Class IIA Level B recommendation from the American Heart Association for patients with paroxysmal AF.

The FDA is evaluating whether the results from the PALLAS trial apply to patients taking dronedarone for paroxysmal or persistent AF or atrial flutter. It also advises healthcare professionals not to prescribe dronedarone to patients with permanent AF.

For more information, please read:

• FDA drug safety communication on dronedarone
• 2011 ACCF/AHA/HRS Focused Update on the Management of Patients with Atrial Fibrillation (Updating the 2006 Guidelines)
• AHA Atrial Fibrillation Research Summit: A Conference Report from the AHA
• PALLAS on ClinicalTrials.gov
• PALLAS trial discontinued (press release)