SAFETY ALERT: Multaq May Increase Risk of Death or Cardiovascular Events

The FDA has notified healthcare professionals that it is reviewing data from a clinical trial that was evaluating the effects of the antiarrhythmic drug Multaq (dronedarone; Sanofi Aventis) in patients with permanent atrial fibrillation. The study was stopped early after the data monitoring committee found a two-fold increase in death, as well as two-fold increases in stroke and hospitalization for heart failure in patients receiving Multaq compared to patients taking a placebo. The FDA is reviewing if this data can be applied to patients using Multaq for its approved indications.

Multaq is indicated to reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent (non-permanent) atrial fibrillation (AF) or atrial flutter (AFL) with a recent episode of AF/AFL and cardiovascular risk factors who are in sinus rhythm or who will be cardioverted.

Patients taking Multaq should talk to their healthcare professional about whether they should continue to take Multaq for non-permanent atrial fibrillation. Patients should not stop taking Multaq without talking to a healthcare professional. Healthcare professionals should not prescribe Multaq to patients with permanent atrial fibrillation.

For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm264204.htm.