Evidence for Flecainide-Induced Tremor
- Tremor is specifically listed as a known adverse effect of flecainide in the 2017 ACC/AHA/HRS guideline for management of patients with ventricular arrhythmias 1
- The FDA drug label for flecainide reports tremor occurring in 4.7% of patients with ventricular arrhythmias treated with flecainide in clinical trials 2
- The incidence of tremor appears to be dose-dependent, with rates of 2.4% at 200 mg/day, 3.4% at 300 mg/day, and 2.0% at 400 mg/day 2
- Tremor is among the neurologic adverse effects that can occur with flecainide, alongside dizziness, visual disturbances, and paresthesias 2, 3
Risk Factors and Mechanism
- Neurologic side effects, including tremor, are among the most common non-cardiac adverse effects of flecainide 3, 4
- Tremor may be more likely to occur at higher plasma concentrations of flecainide, particularly when trough levels exceed 1 mcg/mL 2
- Patients with renal dysfunction may be at increased risk for developing adverse effects including tremor due to reduced clearance of the drug 4
- Tremor appears to be part of the spectrum of central nervous system effects that can occur with flecainide therapy 5
Management of Flecainide-Induced Tremor
- If tremor develops and is bothersome to the patient, consider dose reduction if clinically appropriate 2, 4
- For mild tremor that is tolerable, continued monitoring without dose adjustment may be reasonable 4
- In cases where tremor is severe or significantly impacts quality of life, discontinuation of flecainide and switching to an alternative antiarrhythmic agent may be necessary 6
- When discontinuing flecainide due to tremor, alternative antiarrhythmic options include beta-blockers, calcium channel blockers, propafenone, amiodarone, or sotalol 7
Clinical Context
- Tremor is generally considered a less serious side effect compared to potential cardiac adverse effects of flecainide, which include proarrhythmia, conduction abnormalities, and negative inotropic effects 4
- Most non-cardiac side effects of flecainide, including tremor, are typically mild, transient, and tolerable 4
- In clinical trials, discontinuation of flecainide due to non-cardiac adverse effects occurred in approximately 5.4% of patients 2
- Cerebral symptoms (which may include tremor) were reported as a reason for flecainide withdrawal in some patients in clinical practice 6
Important Considerations
- Flecainide should not be used in patients with structural heart disease, reduced left ventricular ejection fraction, or significant coronary artery disease due to increased risk of serious cardiac adverse effects 1, 8
- Regular monitoring of ECG is recommended during flecainide therapy to detect potential cardiac conduction abnormalities 8
- Careful patient selection and monitoring are essential to ensure that the benefits of flecainide treatment outweigh potential risks 4
- Drug interactions that increase flecainide levels may potentially increase the risk of adverse effects including tremor 7