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.”
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
1. “Which medications are best to control my Atrial Fibrillation?” “I have a heart condition. What medications work best for me?”
A doctor’s choice of drug therapy depends on one’s overall heart health, i.e., if there’s a heart condition other than Atrial Fibrillation.
In general, current medications don’t always work on A-Fib. People tend to react differently to meds. What works for one person may be terrible for another. What medications are best for you is a judgment call only you and your doctor can make..
When trying a new med, there is a fine line between allowing time for your body to adjust to it versus recognizing that this drug is causing bad, unacceptable side effects.
When starting a new med, your doctor may hospitalize you in order to monitor how the drug affects you and to get the dosage right.
If you’ve just been diagnosed with paroxysmal (occasional) A-Fib, flecainide (brand name Tambocor) or propafenone (Rythmol) might work for you. Some people have had good luck with the relatively new drugs dofetilide (brand name Tikosyn) and Rhythmol SR (propafenone sustained release). The newest antiarrhythmic med is Multaq (dronedarone) which is a less toxic substitute for amiodarone. Also see Treatments/Drug Therapies.
Guidelines from the ACC/AHA/ESC based on one’s overall heart health and heart conditions other than Atrial Fibrillation:
• Minimal or no heart disease. Flecainide, propafenone, sotalol. The object is to “minimize organ toxicity,” to select drugs that will not harm the rest of the body. The above drugs can cause “proarrhythmia” (an increase in heart rhythm problems), “but in patients without heart disease, this risk is extremely small.”
• If these drugs don’t work, then dofetilide and amiodarone can be considered. And “in experienced hands one might choose (Pulmonary Vein) Ablation (Isolation) for a primary cure.”
• Congestive heart failure. Only dofetilide and amiodarone have been demonstrated to be safe in randomized trials.
• Congestive heart failure and significant lung disease. “I would likely consider dofetilide as my first choice.”
• Congestive heart failure who are “hypokalemic” (have low levels of potassium). Amiodarone.
• Coronary artery disease. Sotalol is recommended because of its beta blocking and antiarrhythmic effects. Amiodarone or dofetilide combined with a beta blocker can also be used. Propafenone and flecainide aren’t recommended.
• Hypertension. Propafenone or flecainide.
• Hypertension and substantial left ventricular “hypertrophy” (increase in size). Amiodarone, because it has the least proarrhythmic effect.
(These guidelines are based on a presentation by Dr. Eric Prystowsky, see Boston AF/2003/ Prystowsky.)
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