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Causality: well established
Causality assessment · Causality: well established
Dofetilide 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.
Dofetilide ↔ Prolonged QT interval
n=445 co-reports · PRR 25.1 · ROR 26.2
Dofetilide is a potent QT-prolonging antiarrhythmic that can cause torsades de pointes and carries a boxed warning plus mandatory initiation monitoring and renal-function checks; 445 co-reports give PRR 25.1.
Regulatory basis: dofetilide (Tikosyn) prescribing information — boxed warning for QT prolongation/torsades; mandatory in-hospital initiation.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Hours after initiation |
| Strength | met | PRR 25.1 with 445 co-reports |
| Consistency | met | Consistent across studies |
| Specificity | met | Fairly specific to class III |
| Biological gradient | met | Concentration/dose-related |
| Plausibility | met | Known IKr blockade |
| Coherence | met | Fits dofetilide's mechanism |
| Experiment | n/a | Monitored in trials by design |
| Analogy | met | Analogous to sotalol QT effect |
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 →