What is Multaq?
Multaq, also known as Dronedarone, is a drug manufactured by Sanofi-Aventis for the treatment of cardiac arrhythmias, or irregular heartbeat. It is also called an antiarrhythmic drug.
What agencies have approved Multaq?
Advisory Committee of the United States Food and Drug Administration (FDA), March 18, 2009.
FDA, July 2, 2009.
Health Canada, August 12, 2009.
European Medicines Agency, September 24, 2009.
What are the complications, problems, or injuries associated with Multaq?
Various studies have shown that Multaq may cause heart failure, heart attack, stroke, systemic embolism, liver damage, liver failure, myocardial infarction, and even death.
What clinical trials have shown problems with Multaq?
PALLAS (Permanent Atrial Fibrillation Outcome Study Using Dronedarone on Top of Standard Therapy), 2011. Result: Trial stopped due to the finding that Dronedarone increased rates of heart failure, stroke, and death from cardiovascular causes in patients with permanent atrial fibrillation who were at risk for major vascular events.
ANDROMEDA, 2007. Result: Trial stopped early due to mortality in patients found to be twice that seen in the control group.
What FDA warnings have there been for Multaq?
On January 14, 2011, the FDA notified healthcare providers and patients about cases of severe liver injury in patients taking Multaq.
On December 19, 2011, the FDA revised Multaq warning labels to reflect new information about the increased risk of serious cardiovascular events or death when taken by individuals with permanent atrial fibrillation. The warning label for Multaq now reads in part…
“Healthcare professionals should not prescribe Multaq to patients with AF who cannot or will not be converted into normal sinus rhythm (permanent AF), because Multaq doubles the rate of cardiovascular death, stroke, and heart failure in such patients.”
What should you do if you think you may have been injured by Multaq?
Contact the experienced Multaq attorneys at Henry Spiegel Milling LLP today. We have over 100 years of combined experienced in complex drug injury cases, including Tylenol, Phen Phen, and Fosamax. The Multaq lawyers at our firm will evaluate your specific situation to determine if you have a claim against the makers of Dronedarone. Please call us at (404) 832-8000. We represent clients across the United States and charge no fee unless we resolve your case through verdict, or a settlement that you approve.