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29-12-2011 | Article

FDA issues safety alert for dronedarone

Abstract

Safety communication

MedWire News: The US Food and Drug Administration (FDA) has issued safety warnings to be included on labels for the antiarrythmic drug dronedarone.

The warnings follow a safety review of the drug which showed that it increases the risk for adverse cardiovascular (CV) events, including mortality, in patients with permanent atrial fibrillation (AF).

The safety review was based on data from the Permanent Atrial Fibrillation Outcome Study Using Dronedarone on Top of Standard Therapy (PALLAS) and Effect of Dronedarone on Cardiovascular Events in Atrial Fibrillation (ATHENA) study.

As reported previously by MedWire News, the PALLAS trial found that patients who were randomly allocated to receive treatment with dronedarone 400 mg twice daily (n=5400) had a significant 2.29-fold increased risk for a composite of stroke, myocardial infarction, systemic embolism, or CV death compared with the placebo group (n=5400), at 2.7% versus 1.2% (p=0.002).

Patients who received dronedarone were also 1.95 times more likely than the placebo patients to reach the composite of unplanned cardiovascular hospitalization or death, at 7.8% versus 4.1% (p<0.001).

On the other hand, the ATHENA trial found that patients who received dronedarone (n=2301) had a significantly longer median time-to-recurrence of AF and atrial flutter than those who received placebo (n=2327), at 737 versus 498 days.

Furthermore, significantly fewer patients who received dronedarone required electric cardioversion than those in the placebo group, at 15% versus 21%.

Now, according to the FDA, healthcare professionals should not prescribe dronedarone to AF patients who cannot or will not be converted into normal sinus rhythm, as the drug has been shown to double the rate of CV death, stroke, and heart failure (HF) in these patients.

The agency also recommends that healthcare professionals should monitor the cardiac rhythm of patients taking dronedarone using an electrocardiogram at least once every 3 months. If the patient is in AF, dronedarone therapy should be stopped, or if clinically indicated, the patient should be cardioverted.

The new safety warnings also reiterate that dronedarone is indicated to reduce hospitalization for AF in patients with sinus rhythm and a history of non-permanent AF.

And patients who are prescribed dronedarone should receive antithrombotic therapy.

The FDA is now reviewing the risk evaluation and mitigation strategy for dronedarone to determine the changes that should be made to ensure that "its benefits outweigh the risks."

By Piriya Mahendra