FDA warns Multaq increases risk of death, stroke and heart failure in patients with Permanent Atrial Fibrillation

According to the FDA, analysis of preliminary clinical trial data reveals that patients with permanent Atrial Fibrillation who take antiarrhythmic medication Multaq (dronedarone), from Sanofi-Aventis, have double the risk of death and double the risk of being hospitalised for heart failure or developing stroke compared to those on a placebo. This study of the drug's benefits for patients aged 65+ years looked for reductions in unplanned cardiovascular (CV) hospitalization or death from any cause, as well as major CV events. The trial has been halted early because of these findings. Now the FDA will decide what implications this has for Multaq's approved use in patients with paroxysmal or persistent atrial fibrillation (non-permanent atrial fibrillation).