Flecainide Acetate Side Effects

ADVERSE REACTIONS In post-myocardial infarction patients with asymptomatic PVCs and non-sustained ventricular tachycardia, flecainide acetate therapy was found to be associated with a 5.1% rate of death and non-fatal cardiac arrest, compared with a 2.3% rate in a matched placebo group.

(See WARNINGS .) Adverse effects reported for flecainide acetate, described in detail in the WARNINGS section, were new or worsened arrhythmias which occurred in 1% of 108 patients with PSVT and in 7% of 117 patients with PAF;

and new or exacerbated ventricular arrhythmias which occurred in 7% of 1330 patients with PVCs, non-sustained or sustained VT.

In patients treated with flecainide for sustained VT, 80% (51/64) of proarrhythmic events occurred within 14 days of the onset of therapy.

198 patients with sustained VT experienced a 13% incidence of new or exacerbated ventricular arrhythmias when dosage was initiated at 200 mg/day with slow upward titration, and did not exceed 300 mg/day in most patients.

In some patients, flecainide acetate treatment has been associated with episodes of unresuscitatable VT or ventricular fibrillation (cardiac arrest).

(See WARNINGS .) New or worsened CHF occurred in 6.3% of 1046 patients with PVCs, non-sustained or sustained VT.

Of 297 patients with sustained VT, 9.1% experienced new or worsened CHF.

New or worsened CHF was reported in 0.4% of 225 patients with supraventricular arrhythmias.

There have also been instances of second- (0.5%) or third-degree (0.4%) AV block.