FDA reviews increased risk of death and CV events with dronedarone in permanent

Updated:Feb 2,2012

FDA reviews increased risk of death and CV events with dronedarone in permanent AF
 

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.

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