FDA Warning: Multaq (dronedarone)

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Increased Risk of Death or Serious Cardiovascular Events from Multaq

FDA reported they completed a safety review of Multaq (dronedarone). This review revealed the increased the risk of serious cardiovascular events, including death, when used by patients in permanent atrial fibrillation (AF). The review of two clinical trials resulted in the FDA warning of the potential serious cardiovascular risks with the drug. The study of the potentially dangerous drug was stopped 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.
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The Multaq drug label has been revised with 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 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.
  • 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)
  • Patients prescribed Multaq should receive appropriate antithrombotic therapy.

Dangerous Effects of Multaq

In an effort to allow pharmaceutic companies to make the most money on their new drugs, the are permitted to go to market after clinical trial that are often insufficient in both time and number of participants to truly understand the risks involved. They real testing occurs on on patients taking the drug in the first few years. If you were injured or if you lost a loved one due to the harmful side effects of Multaq, contact the Clore Law Group today for a free consultation.

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