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Causality: well established
Causality assessment · Causality: well established
Linagliptin and Pancreatitis: 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.
Linagliptin ↔ Pancreatitis
n=331 co-reports · PRR 7.3 · ROR 7.4
Linagliptin is a DPP-4 inhibitor; acute pancreatitis is a labelled, if uncommon, risk (331 co-reports, PRR 7.3), and the label advises discontinuation if pancreatitis is suspected. The signal sits within the wider debate about incretin-based therapies and pancreatitis, where trial data have not consistently confirmed an excess.
Regulatory basis: linagliptin (Tradjenta) prescribing information — acute pancreatitis warning.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | partial | Latency of days to months is plausible |
| Strength | met | PRR 7.3, moderate |
| Consistency | partial | Reported across DPP-4 inhibitors |
| Specificity | not established | Cannot exclude cholelithiasis or alcohol |
| Biological gradient | not established | No established dose relationship |
| Plausibility | partial | Biologically debated |
| Coherence | not established | Meta-analyses are inconclusive |
| Experiment | n/a | Rare in trials |
| Analogy | partial | Debated analogy across incretin drugs |
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 — Cardiovascular and Renal Microvascular Outcome Study With Linagliptin in Patients With Type 2 Diabetes Mellitus (CARMELINA) (NCT01897532)
| Adverse event | Placebo (n=3485) · Linagliptin (n=3494) | |
|---|---|---|
| Pancreatitis acute | 3/3485 | 7/3494 |
| Pancreatitis | 3/3485 | 6/3494 |
| Pancreatitis chronic | 6/3485 | 2/3494 |
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 →