← All causality assessments
Contested: signal not confirmed by large randomized trials
Causality assessment · Contested: signal not confirmed by large randomized trials
Sitagliptin and Pancreatic cancer: 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.
Sitagliptin ↔ Pancreatic cancer
n=1,670 co-reports · PRR 17.8 · ROR 18.2
Sitagliptin is a DPP-4 inhibitor; an excess of pancreatic cancer was reported in early analyses of incretin-based therapies and appears here as 1,670 pancreatic-carcinoma co-reports (PRR 17.8), but the signal is weak and consistently disappears once the underlying diabetes, obesity, and smoking are taken into account, so causality remains unproven.
Regulatory basis: sitagliptin (Januvia) prescribing information — pancreatic-cancer reviews by FDA/EMA; no confirmed causal link.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | partial | Latency of years is plausible |
| Strength | met | PRR 17.8, large |
| Consistency | not established | Not consistently reproduced |
| Specificity | not established | Cannot exclude confounding by diabetes |
| Biological gradient | not established | No clear dose relationship |
| Plausibility | partial | Biologically debated |
| Coherence | not established | Randomised outcome trials are negative |
| Experiment | not established | Pooled analyses do not confirm it |
| 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.
✗ No ClinicalTrials.gov results-posting trial in the top search hits for sitagliptin captured pancreatic cancer as a tracked adverse event in a usable structure. Pancreatic cancer has a long latency and low incidence, so the diabetes outcome trials could not detect it.