Causality assessment · Expected pharmacological effect

Lacosamide and Bradycardia: is the FAERS signal real?

n=402 co-reports · PRR 4.3 · ROR 4.4

Lacosamide side-effect profile All assessments See in the full list

A written Bradford Hill assessment of one drug–event pair. The grade is a judgement about the signal, not a statement that this drug causes this event in any one person; FAERS counts are reports, not rates.

Expected pharmacological effect

Lacosamide ↔ Bradycardia

n=402 co-reports · PRR 4.3 · ROR 4.4

Lacosamide is an antiepileptic that enhances slow sodium-channel inactivation, which prolongs the PR interval and can cause bradycardia, AV block, and syncope (402 co-reports, PRR 4.3). The label advises caution in patients with conduction disease and in combination with other PR-prolonging drugs, and doses are titrated slowly; the effect is dose-related.

Regulatory basis: lacosamide (Vimpat) prescribing information — PR-interval prolongation and bradycardia.

Bradford Hill viewpoint	Status	Note
Temporality (necessary)	met	Bradycardia occurs with therapy
Strength	met	PRR 4.3, modest
Consistency	met	Seen across trials and series
Specificity	partial	Shared with other sodium-channel blockers
Biological gradient	met	Dose-related
Plausibility	met	Effect on cardiac conduction
Coherence	met	Fits the pharmacology
Experiment	met	ECG changes measured in trials
Analogy	met	Analogous to other PR-prolonging antiepileptics

This table is this page's own qualitative read of the literature cited above, not an automated or citation-gated assessment — see the note at the bottom of this page.

✓ Trial evidence found — Post-Authorization Safety Study to Assess the Safety of Vimpat as add-on Therapy in Patients With Partial-onset Seizures (NCT00771927)

Adverse event	Lacosamide (n=511) · Other AED (n=493)
Sinus Bradycardia	2/511	0/493
Bradycardia	1/511	3/493

Post-marketing signal terms appear in this trial's posted adverse-event tables; per-arm counts shown as affected/at-risk. View on ClinicalTrials.gov →