FDA warning on Multaq and Increased Risk of Death

Thu, Dec 22, 2011

FDA Drug Advisory, Multaq

U.S. Food and Drug Administration has completed a safety review of Multaq (generic name dronedarone).  According to this review, in patients with permanent atrial fibrillation (AF),  Multaq increased the risk of serious cardiovascular events, including death.

The  data was obtained from ATHENA and PALLAS clinical trials.  New information and recommendations are being provided by FDA for the use of Multaq to manage the potential serious cardiovascular risks with dronedarone.

The Multaq drug label has been revised with the following changes and recommendations:

  1. 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.
  2. Healthcare professionals should monitor heart (cardiac) rhythm by electrocardiogram (ECG) at least once every 3 months. If the patient is in AF, Multaq should be stopped or, if clinically indicated, the patient should be cardioverted.
  3. Multaq is indicated to reduce hospitalization for AF in patients in sinus rhythm with a history of non-permanent AF (known as paroxysmal or persistent AF)
  4. Patients prescribed Multaq should receive appropriate antithrombotic therapy.

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