FDA Says Clinical Trial Data on Multaq Indicated Risks of Stroke, Heart Failure

The Food and Drug Administration July 21 issued a drug safety communication about giving the antiarrhythmic drug Multaq (dronedarone) to patients who have permanent atrial fibrillation.

FDA said it is reviewing data from a clinical trial that was stopped early after it was found that these patients faced a two-fold increase in death and two-fold increases in stroke and hospitalization for heart failure when given Multaq as opposed to patients given a placebo.

Paris-based Sanofi-aventis had been conducting a “randomized, double blind, placebo controlled, parallel group trial for assessing the clinical benefit of dronedarone 400 mg BID on top of ...