Multaq (Dronedarone) for A fib treatment

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Multaq (Dronedarone) for A fib treatment

In December 2011, the Food and Drug Administration announced that Multaq (Dronedarone) should not be used by patients with permanent atrial fibrillation (AF). In these patients, dronedarone doubles the rate of cardiovascular death, stroke and heart failure, the FDA said.

However, the FDA said dronedarone is still safe to treat patients with brief bouts of irregular heart rhythm and doctors should still monitor heart rhythms at least once every three months for all patients taking the drug.

On July 22, 2011 PALLAS, a  dronedarone trial, was stopped early when patients had a two-fold increase in death, stroke and heart failure rates in patients with permanent a-fib.

PALLAS events as of June 30, 2011

Adverse event

Placebo (n=1577), n (%)

Dronedarone (n=1572), n (%)

Hazard ratio

p

CV death, MI, stroke, systemic embolism

14 (0.9)

32 (2)

0.009

Death, unplanned CV hospitalization

81 (5.1)

118 (7.5)

0.006

Death

7 (0.4)

16 (1)

0.065

MI

3 (0.2)

3 (0.2)

Stroke

7 (0.4)

17 (1.1)

0.047

HF hospitalization

15 (1)

34 (2.2)

0.008

It also became apparent that dronedarone could interact with coumadin, an anticoagulant used in most a-fib patients to prevent strokes, leading to an increase in the anticoagulation effect and risk of hemorrhage.  Near the end of 2010 cases of severe liver damage due to dronedarone were published, and on Feb 11, 2011 the FDA warned that dronedarone should be stopped if there is a suspicion of liver damage.

The primary question remaining is whether patients currently on dronedarone who are maintaining a regular sinus rhythm without any or many episodes of intermittent a-fib should continue taking it.  As recommended by the FDA, you should contact your physician to see if you are better off without it.

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