The use of Dronedarone may be associated with: a) an elevated risk of worsening, or new-onset, heart failure; b) liver toxicity Patients should be asked to be vigilant for the symptoms of heart failure or liver toxicity during treatment, and should undergo regular liver function testing.

Dronedarone ( Multaq ) is an antiarrhythmic agent indicated in adult, clinically stable patients with history of, or current, non-permanent atrial fibrillation to prevent recurrence of atrial fibrillation or to lower ventricular rate.
Dronedarone is available as a 400 mg film-coated tablet and the recommended dose is 400 mg twice daily.

Use of Dronedarone in patients with heart failure in clinical trials

In a placebo-controlled study of 627 patients with symptomatic congestive heart failure ( ANDROMEDA ), a higher risk of mortality was observed in the Dronedarone group ( n=25 ) compared with the placebo group ( n=12; hazard ratio, HR=2.13 ). Because of this finding, Dronedarone is contraindicated in patients who are haemodynamically unstable, including those with symptoms of heart failure at rest or with minimal exertion ( ie, New York Heart Association class IV and unstable class III heart failure ).
Furthermore, dronedarone is not recommended for clinically stable patients with recent ( 1–3 months ) New York Heart Association class III heart failure or with left ventricular ejection fraction less than 35 percent because of limited experience in these patients.

Recently reported cases of new-onset heart failure

Up to Jan 26, 2011, 257 serious cases of new-onset or worsening heart failure ( or suspected reactions synonymous with heart failure ) have been reported worldwide.
Heart failure may be associated with complications of atrial fibrillation in some patients. In five placebo-controlled studies of Dronedarone, the crude incidence of heart-failure events was 369 of 3282 ( 11.2% ) in the Dronedarone group and 312 of 2875 ( 10.9% ) in the placebo group.

Risk of adverse liver reactions

Case reports of liver injury, including two cases of liver failure requiring transplantation, have been reported in patients receiving Dronedarone. Some of these cases have occurred shortly after start of treatment.

Advice for healthcare professionals: cardiac risk

• Patients should be advised to consult a physician if they develop or experience worsening signs or symptoms of heart failure, such as weight gain, dependent oedema, or increased dyspnoea;

• If heart failure develops or worsens, consider suspending or discontinuing Dronedarone.

Source: Drug Safety Update – MHRA, 2011

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