FDA Halts Trail Of Dronedarone (Multaq), Deaths doubledPosted in Product Liability Keith Belt
The utilization of new and powerful drugs can cause unanticipated adverse reactions to patients due to the unique composition of each person and the other medical treatments they may be receiving, says Alabama liability attorney Keith T. Belt
The FDA confirmed Thursday that it is reviewing safety data from a clinical trial of dronedarone (Multaq) that was halted when the data monitoring committee discovered a twofold increase in death among atrial fibrillation patients treated with the drug.
In the trial of more than 3,000 patients, there were 32 deaths in the dronedarone arm versus 14 in the placebo group and for the combined endpoint of death or unplanned hospitalization, the difference was also highly significant, at 118 versus 81. There were 17 strokes in the dronedarone arm versus seven in the controls.
In January, Sanofi-Aventis, the drug’s maker, and the FDA warned that reports of acute liver injury associated with the drug had been received. Then, earlier this month sanofi-aventis, announced that it had halted its Permanent Atrial fibriLLAtion Outcome Study using Dronedarone on Top of Standard Therapy (PALLAS) study. The study enrolled patients with permanent atrial fibrillation and randomized them to dronedarone or placebo on top of standard therapy.
Currently more than 240,000 Americans are taking dronedarone.