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Causality: well established
Causality assessment · Causality: well established
Sotalol and Prolonged QT interval: is the FAERS signal real?
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.
Sotalol ↔ Prolonged QT interval
n=446 co-reports · PRR 15.9 · ROR 16.3
Sotalol prolongs the QT interval through potassium-channel blockade and can cause torsades de pointes; it carries a boxed warning for this proarrhythmia and requires initiation with ECG monitoring and attention to renal function; 446 co-reports give PRR 15.9.
Regulatory basis: sotalol prescribing information — boxed warning for QT prolongation and torsades de pointes; ECG monitoring.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Hours after dosing |
| Strength | met | PRR 15.9 with 446 co-reports |
| Consistency | met | Consistent across studies |
| Specificity | not established | QT prolongation has many causes |
| Biological gradient | met | Concentration/dose-related |
| Plausibility | met | Known potassium-channel blockade |
| Coherence | met | Fits class III antiarrhythmic effect |
| Experiment | n/a | Often monitored in trials |
| Analogy | met | Analogous to other QT-prolonging antiarrhythmics |
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 — Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial (NCT00911508)
| Adverse event | Left Atrial Ablation (n=1108) · Rate or Rhythm Control Therapy (n=1096) | |
|---|---|---|
| ELECTROCARDIOGRAM QT PROLONGED | 2/1108 | 1/1096 |
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 →