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FLECAINIDE ACETATE
Flecainide Acetate is a marketed drug primarily indicated for the treatment of Paroxysmal Supraventricular Tachycardias (PSVT). Its key strength lies in its established market presence and efficacy, supported by a key composition patent expiring in 2028. The primary risk is the potential increase in competition as the patent approaches expiration.
At a glance
| Generic name | FLECAINIDE ACETATE |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1985 |
Approved indications
- Paroxysmal Supraventricular Tachycardias (PSVT)
- Paroxysmal Atrial Fibrillation/Flutter (PAF)
- Documented Ventricular Arrhythmias
Boxed warnings
- WARNINGS Mortality Flecainide acetate was included in the National Heart Lung and Blood Institute's Cardiac Arrhythmia Suppression Trial (CAST), a long-term, multicenter, randomized, double-blind study in patients with asymptomatic non-life-threatening ventricular arrhythmias who had a myocardial infarction more than six days but less than two years previously. An excessive mortality or non-fatal cardiac arrest rate was seen in patients treated with flecainide acetate compared with that seen in patients assigned to a carefully matched placebo-treated group. This rate was 16/315 (5.1%) for flecainide acetate and 7/309 (2.3%) for the matched placebo. The average duration of treatment with flecainide acetate in this study was ten months. The applicability of the CAST results to other populations (e.g., those without recent myocardial infarction) is uncertain, but at present, it is prudent to consider the risks of Class IC agents (including flecainide acetate), coupled with the lack of any evidence of improved survival, generally unacceptable in patients without life-threatening ventricular arrhythmias, even if the patients are experiencing unpleasant, but not life-threatening, symptoms or signs. Ventricular Pro-arrhythmic Effects in Patients with Atrial Fibrillation/Flutter A review of the world literature revealed reports of 568 patients treated with oral flecainide acetate for paroxysmal atrial fibrillation/flutter (PAF). Ventricular tachycardia was experienced in 0.4% (2/568) of these patients. Of 19 patients in the literature with chronic atrial fibrillation (CAF), 10.5% (2) experienced VT or VF. FLECAINIDE IS NOT RECOMMENDED FOR USE IN PATIENTS WITH CHRONIC ATRIAL FIBRILLATION. Case reports of ventricular proarrhythmic effects in patients treated with flecainide acetate for atrial fibrillation/flutter have included increased PVCs, VT, ventricular fibrillation (VF), and death. As with other Class I agents, patients treated with flecainide acetate for atrial flutter have been reported with 1:1 atrioventricular conduction due to slowing the atrial rate. A paradoxical increase in the ventricular rate also may occur in patients with atrial fibrillation who receive flecainide acetate. Concomitant negative chronotropic therapy such as digoxin or beta-blockers may lower the risk of this complication.
Common side effects
- Dizziness
- Visual Disturbances
- Dyspnea
- Headache
- Nausea
- Fatigue
- Palpitation
- Chest Pain
- Asthenia
- Tremor
- Constipation
- Edema
Drug interactions
- digitalis preparations
- propranolol
- beta-adrenergic blocking agents
- highly protein-bound drugs (e.g., anticoagulants)
- diuretics
- enzyme inducers (phenytoin, phenobarbital, carbamazepine)
- cimetidine
- amiodarone
- quinidine
- disopyramide
- verapamil
- nifedipine
Key clinical trials
- Flecainide in Idiopathic Premature Ventricular Contractions and Related Cardiomyopathy
- INhalation of Flecainide to Convert Recent Onset SympTomatic Atrial Fibrillation to siNus rhyThm (INSTANT) (PHASE2)
- Assessment of Flecainide to Lower the Patent Foramen Ovale Closure Risk of Atrial Arrhythmia or Tachycardia (PHASE3)
- Flecainide Acetate Inhalation Solution for Cardioversion of Recent-Onset, Symptomatic Atrial Fibrillation (PHASE3)
- Flecainide in Treating Patients With Chronic Neuropathic Pain (PHASE2)
- To Evaluate the Impact of Oral Flecainide on Quality of Life in Patients With Paroxysmal Atrial Fibrillation (PHASE4)
- Flecainide for Catecholaminergic Polymorphic Ventricular Tachycardia (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- FLECAINIDE ACETATE CI brief — competitive landscape report
- FLECAINIDE ACETATE updates RSS · CI watch RSS