US FDA probes cardio events, deaths in Sanofi halted Multaq study
This article was originally published in Scrip
Executive Summary
Two weeks after Sanofi halted a Phase IIIb study of its antiarrhythmic drug Multaq (dronedarone) in patients with permanent atrial fibrillation at the behest of the trial's data monitoring committee after a two-fold increase in death, stroke and heart failure-related hospitalizations were identified, the US FDA said it was taking up an examination of the data (scripintelligence, 8 July 2011).