FDA: Dronedarone Tied to Cardiovascular Events, Death

PALLAS study stopped due to higher risk of cardiovascular events and deaths in those taking drug

FRIDAY, July 22 (HealthDay News) -- The U.S. Food and Drug Administration has notified health care professionals and patients that dronedarone (Multaq) may be associated with an increased risk of death and adverse cardiovascular events, including stroke and hospitalization for heart failure.

Dronedarone is used to reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors, who are in sinus rhythm or who will be cardioverted. Recently, the PALLAS study was stopped because 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 dronedarone compared to patients taking a placebo.

The FDA is currently evaluating whether and how the preliminary results of the PALLAS study apply to patients taking the drug for paroxysmal or persistent AF or AFL. The study results are currently considered preliminary and the FDA will update the public when more information is available.

According to the FDA, "at this time, patients taking Multaq should talk to their health care professional about whether they should continue to take Multaq for non-permanent atrial fibrillation. Patients should not stop taking Multaq without talking to a health care professional. Health care professionals should not prescribe Multaq to patients with permanent atrial fibrillation."

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