Black Box Warning

In the Cardiac Arrhythmia Suppression Trial (CAST), patients with a recent myocardial infarction and asymptomatic, non-life-threatening ventricular ectopy who were treated with flecainide had a higher rate of death and nonfatal cardiac arrest (about 7.7%) than those given placebo (about 3.0%). Flecainide is not recommended for patients with non-life-threatening ventricular arrhythmias, even when symptomatic, and should be avoided in patients with structural heart disease or coronary artery disease. Proarrhythmic effects have also been seen in patients treated for atrial fibrillation/flutter, and use is not recommended for chronic atrial fibrillation. Therapy for sustained ventricular tachycardia should be initiated in hospital with continuous cardiac monitoring.

What this means:A black box warning is the FDA's strongest required safety notice. It signals a serious or life-threatening risk. Patients should review this with their prescriber before starting, continuing, or switching Flecainide.

Other warnings & precautions

Reserve flecainide for patients without structural heart disease; it is contraindicated in patients with recent myocardial infarction and is not recommended in chronic (permanent) atrial fibrillation.
Contraindicated in pre-existing second- or third-degree AV block, or bifascicular (right bundle branch block with left hemiblock) conduction disturbance, unless a functioning pacemaker is present.
Contraindicated in cardiogenic shock and in patients with known hypersensitivity to flecainide.
Has a negative inotropic effect and may precipitate or worsen heart failure; use cautiously and monitor in patients with reduced ventricular function.
When treating atrial flutter or atrial fibrillation, co-administer an AV-nodal blocking agent (beta-blocker or non-dihydropyridine calcium channel blocker) to prevent rapid 1:1 atrioventricular conduction.
Correct hypokalemia and hyperkalemia before and during therapy, as electrolyte disturbances can blunt or exaggerate flecainide's effects.
Can unmask a Brugada syndrome ECG pattern; investigate if a characteristic pattern appears.
Adjust dose in renal or hepatic impairment and consider plasma level monitoring; therapeutic trough is approximately 0.2 to 1.0 mcg/mL.

Other warnings & precautions

Reserve flecainide for patients without structural heart disease; it is contraindicated in patients with recent myocardial infarction and is not recommended in chronic (permanent) atrial fibrillation.

Contraindicated in pre-existing second- or third-degree AV block, or bifascicular (right bundle branch block with left hemiblock) conduction disturbance, unless a functioning pacemaker is present.

Contraindicated in cardiogenic shock and in patients with known hypersensitivity to flecainide.

Has a negative inotropic effect and may precipitate or worsen heart failure; use cautiously and monitor in patients with reduced ventricular function.

When treating atrial flutter or atrial fibrillation, co-administer an AV-nodal blocking agent (beta-blocker or non-dihydropyridine calcium channel blocker) to prevent rapid 1:1 atrioventricular conduction.

Correct hypokalemia and hyperkalemia before and during therapy, as electrolyte disturbances can blunt or exaggerate flecainide's effects.

Can unmask a Brugada syndrome ECG pattern; investigate if a characteristic pattern appears.

Adjust dose in renal or hepatic impairment and consider plasma level monitoring; therapeutic trough is approximately 0.2 to 1.0 mcg/mL.

Flecainide Black Box Warning

Black Box Warning

Other warnings & precautions

Flecainide Black Box Warning

Black Box Warning

Other warnings & precautions