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FDA Revises Dronedarone Label

Issues warning on use in patients with permanent AFib

The Food and Drug Administration (FDA) announced on Dec. 19 that it has completed a safety review of dronedarone (Multaq) and found it increased the risk of serious cardiovascular events, including death, when used by patients with permanent atrial fibrillation (AFib).

The review was based on data from two clinical trials, PALLAS and ATHENA. FDA is providing new information and recommendations for the use of dronedarone to manage the potential serious cardiovascular risks with the drug. The drug label has been revised with the following changes and recommendations:

  • Health care professionals should not prescribe dronedarone to patients with AFib who cannot or will not be converted into normal sinus rhythm (permanent AFib), because dronedarone doubles the rate of cardiovascular death, stroke and heart failure in such patients.
  • Health care professionals should monitor cardiac rhythm by electrocardiogram (ECG) at least once every three months. If the patient is in AFib, dronedarone should be stopped or, if clinically indicated, the patient should be cardioverted.
    Dronedarone is indicated to reduce hospitalization for AFib in patients in sinus rhythm with a history of non-permanent AFib.
  • Patients prescribed dronedarone should receive appropriate antithrombotic therapy.

Read the complete safety alert.

Current ACC, American Heart Association and the European Society of Cardiology guidelines for the management of patients with AFib say the drug is reasonable to decrease the need for hospitalization for cardiovascular events in patients with paroxysmal AFib or after conversion of persistent AFib. While the update suggests that dronedarone can be initiated during outpatient therapy, it also articulates that it should not be administered to patients with class IV heart failure or patients who have had an episode of decompensated heart failure in the past four weeks, especially if they have depressed left ventricular function.

For more information on AFib, including links to the updated guidelines and resources for patients and professionals, visit afibprofessional.org.