What is the safety of Multaq (dronedarone) 400mg twice daily (BID) in atrial fibrillation?

From the Guidelines

Multaq (dronedarone) 400mg twice daily is not recommended for patients with atrial fibrillation due to significant safety concerns, including increased risk of death, liver injury, and interactions with other medications. The European Society of Cardiology working group on cardiovascular pharmacotherapy highlights the potential adverse effects of antiarrhythmic drugs, including dronedarone, in older people with cardiovascular disease 1. According to the study, antiarrhythmic drugs can increase the risk of bradycardia, atrioventricular block, heart failure, and hypotension, particularly in patients with structural heart disease 1.

Some key points to consider when evaluating the safety of Multaq 400mg BID in atrial fibrillation include:

• The risk of fatal hepatotoxicity associated with dronedarone, which necessitates regular monitoring of liver function tests, especially during the first six months of treatment 1
• The potential for dronedarone to cause intracardiac conduction block, heart failure, and hypotension, particularly in patients with poor left ventricular function or structural heart disease 1
• The importance of ECG monitoring to assess QT interval and detect potential proarrhythmic effects of dronedarone 1
• The need for careful consideration of drug interactions, including those with digoxin, beta-blockers, calcium channel blockers, and statins, which may require dosage adjustments 1

In light of these safety concerns, alternative antiarrhythmic options may be preferable for many patients with atrial fibrillation. It is essential to weigh the potential benefits of Multaq against its risks and consider individual patient factors, such as comorbidities and concomitant medications, when making treatment decisions 1.

From the FDA Drug Label

In patients with permanent atrial fibrillation, MULTAQ doubles the risk of death, stroke and hospitalization for heart failure. MULTAQ is contraindicated in patients in atrial fibrillation (AF) who will not or cannot be cardioverted into normal sinus rhythm. The recommended dosage of MULTAQ is 400 mg twice daily in adults MULTAQ should be taken as one tablet with the morning meal and one tablet with the evening meal.

The safety of Multaq 400mg BID in atrial fibrillation is a concern due to the increased risk of death, stroke, and hospitalization for heart failure in patients with permanent atrial fibrillation. Additionally, Multaq is contraindicated in patients with atrial fibrillation who will not or cannot be cardioverted into normal sinus rhythm. Therefore, Multaq 400mg BID should only be used in patients with atrial fibrillation who can be cardioverted into normal sinus rhythm, and with caution due to the potential risks. 2

From the Research

Safety of Multaq 400mg BID in Atrial Fibrillation

• The safety of Multaq (dronedarone) 400mg BID in atrial fibrillation has been evaluated in several studies 3, 4, 5, 6.
• Dronedarone is a class III antiarrhythmic drug that has been shown to be effective in maintaining sinus rhythm in patients with atrial fibrillation 5.
• However, its use is not without risks, and it has been associated with an increased risk of cardiovascular events, stroke, and congestive heart failure in certain patient populations 4.
• Compared to amiodarone, dronedarone has been shown to have a lower risk of extracardiac toxicities, but its efficacy is also lower 6.
• The choice of antiarrhythmic drug for atrial fibrillation should be individualized based on patient characteristics, including the presence of heart failure, and the risk of adverse effects 3, 5.
• It is essential to carefully evaluate the benefits and risks of dronedarone and other antiarrhythmic drugs in patients with atrial fibrillation, and to monitor them closely for adverse effects 4, 6.

Adverse Effects of Dronedarone

• Dronedarone has been associated with several adverse effects, including:
  • Gastrointestinal disorders (diarrhea, nausea, vomiting) 6
  • Cutaneous disorders 6
  • Transient elevation of creatinine levels 6
  • Renal failure (rare) 6
  • Bradycardia and QT prolongation (as with other antiarrhythmic drugs) 6
• The risk of adverse effects with dronedarone may be higher in certain patient populations, such as those with heart failure or renal impairment 4, 6.

Comparison with Other Antiarrhythmic Drugs

• Dronedarone has been compared to other antiarrhythmic drugs, including amiodarone, sotalol, flecainide, and propafenone 4.
• Amiodarone has been shown to have a higher risk of cardiovascular events, stroke, and congestive heart failure compared to dronedarone, especially in patients without a history of heart failure 4.
• The choice of antiarrhythmic drug should be based on individual patient characteristics and the risk of adverse effects 3, 5.