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Roy Salmon Patient, A-Fib Free; pacemakerclub.com, Sept. 2013

 FAQs A-Fib Drug Therapy: Safety dronedarone vs amiodarone

Drug Therapies for Atrial Fibrillation, A-Fib, Afib

Safety of dronedarone

25. “Is the antiarrhythmic drug Multaq [dronedarone] safer than taking amiodarone? How does it compare to other antiarrhythmic drugs?”

Multaq is probably safer than amiodarone, but it isn’t just “amiodarone-lite.”

Higher Death Rates with Dronedarone

Some studies indicate Multaq by Sanofi-Aventis (generic name: dronedarone) has its own set of problems.

In a study of dronedarone in high-risk patients with permanent A-Fib (PALLAS-3,236 patients), patients taking dronedarone were dying at more than twice the rate of those on a placebo. The ratio of stroke and hospitalization for heart failure was also more than twice as high.

The EMA recommends dronedarone not be used in patients still in A-Fib.

Dronedarone Shouldn’t Be Used in Patients in A-Fib

The European Medicines Agency (EMA) has recommended that the antiarrhythmic drug dronedarone not be used in patients still in A-Fib, that it should be discontinued if A-Fib reoccurs, that it shouldn’t be used in patients who have previous liver or lung injury following treatment with amiodarone, and that patients using it should have their liver and lung functions regularly monitored.

Who Should be Taking Dronedarone (If Anyone)?

The Committee for Medicinal Products for Human Use (CHMP) of the EMA said that dronedarone may be a useful option in patients who are in sinus rhythm after a successful cardioversion. But even in this case, dronedarone should only be prescribed after alternate treatment options have been considered.

…Dronedarone should only be prescribed after alternate treatment options have been considered.

About dronedarone, noted A-Fib blogger, Dr. John Mandrola wrote, “I’m surprised that the drug has persisted. I don’t know any of my colleagues who would start a patient out on Multaq [dronedarone]. It just doesn’t work.”

Editor’s Comments
According to these studies and news reports, no one with any type of A-Fib should be taking dronedarone (Multaq).
This is a major change in treatment options for patients with A-Fib.
Dronedarone may be associated with increased strokes, hospitalizations, heart failure, liver damage, lung damage and death. And it may not be very effective anyway.
No antiarrhythmic drug is 100% safe and effective for all A-Fib patients. But until we get more favorable research on dronedarone, all patients with A-Fib should consider not taking it and try alternative options.


Connolly SJ. Dronedarone in High-Risk Permanent Atrial Fibrillation. PALLAS Clinical trial (Permanent Atrial Fibrillation Outcome Study Using Dronedarone on Top of Standard Therapy). New England Journal of Medicine, 2011; 365: 2268-76. http://www.nejm.org/doi/full/10.1056/NEJMoa1109867 DOI: 10.1056/NEJMoa1109867

O’Riordan, Michael. “EMA recommends restricting use of dronedarone” HeartWire, Sept. 22, 2011. http://www.medscape.com/viewarticle/750196

Burton, Thomas M., FDA Reviews Heart-Rhythm Drug. The Wall Street Journal, September 22, 2011. http://www.wsj.com/articles/SB10001424053111904563904576585091471862916

The European Medicines Agency (EMA): a decentralised agency of the European Union (EU) is responsible for the scientific evaluation, supervision and safety monitoring of medicines developed by pharmaceutical companies for use in the EU. http://www.ema.europa.eu/ema/; See: Multaq/dronedarone

Last updated: Wednesday, May 25, 2016 Return to FAQ Drug Therapies

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