SAFETY ALERT: Increased Risk of Death or Cardiovascular Events with Multaq

The FDA has completed a safety review of Multaq (dronedarone; Sanofi Aventis) that showed that Multaq increases the risk of serious cardiovascular events, including death, when used by patients in permanent atrial fibrillation (AF). The review was based on data from two clinical trials, the PALLAS trial (Permanent Atrial FibriLLAtion Outcome Study Using Dronedarone on Top of Standard Therapy) and the ATHENA trial (which supported Multaq's approval for treatment of non-permanent AF).

The product labeling for Multaq has been updated to include the following changes and recommendations:

  • 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
  • Healthcare professionals should monitor cardiac rhythm by electrocardiogram at least once every three months. If the patient is in AF, Multaq should be stopped or, if clinically indicated, the patient should be cardioverted.
  • Multaq is indicated to reduce hospitalization for AF in patients in sinus rhythm with a history of paroxysmal or persistent (non-permanent) AF
  • Patients prescribed Multaq should receive appropriate antithrombotic therapy.

Multaq is indicated to reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent 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.

For more information visit www.fda.gov/Drugs/DrugSafety/ucm283933.htm.