← All causality assessments
Causality: well established
Causality assessment · Causality: well established
Pioglitazone Hydrochloride and Cardiac Failure: 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.
Pioglitazone Hydrochloride ↔ Cardiac Failure
n=37 co-reports · PRR 7.8 · ROR 8.0
Vortioxetine is a multimodal antidepressant. Suicidal ideation carries an antidepressant-class label warning. 266 co-reports (PRR 23.2) reflect the known antidepressant class signal. The label carries a boxed warning for suicidal ideation.
Boxed warning: vortioxetine label (suicidal ideation/behaviour). Antidepressant class.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Documented in label |
| Strength | met | PRR 23.2 with 266 co-reports |
| Consistency | met | Reproduced across SSRI/SNRI class |
| Specificity | not established | Not specific |
| Biological gradient | not established | No consistent gradient |
| Plausibility | partial | Serotonergic mechanism involved |
| Coherence | met | Class pattern consistent |
| Experiment | n/a | Not an RCT endpoint |
| Analogy | met | Other SSRIs/SNRIs show same |
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.
✗ No ClinicalTrials.gov results-posting trial in the top search hits for Pioglitazone captured cardiac failure as a tracked adverse event in a usable structure. Suicidal ideation is class-wide; antidepressant RCTs include monitoring.