ArticleFrontiers in pharmacology2026
Haemorrhagic event reporting with concomitant gemcitabine and warfarin: a VigiBase disproportionality analysis.
Article in Frontiers in pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Purpose: Case reports suggest that concomitant gemcitabine and warfarin may lead to clinically important over-anticoagulation and bleeding, but population-level characterization remains limited. We evaluated whether concomitant gemcitabine and oral anticoagulants, particularly warfarin, were associated with disproportionate reporting of haemorrhagic events in VigiBase, the WHO global database of individual case safety reports. Methods: We performed a retrospective pharmacovigilance study of VigiBase reports from 1 January 1994 to 28 April 2025. Haemorrhagic events were defined using the Standardised MedDRA Query "Haemorrhages". For each anticoagulant, we fitted multivariable logistic regression models including a gemcitabine × anticoagulant interaction term, adjusting for age group, sex, WHO region, and bleeding-related co-medications. A sensitivity analysis was restricted to serious reports. Additional analyses adjusted for calendar period. Time-to-onset and dechallenge/rechallenge were summarised where available. Results: Among 6,191,806 eligible reports, 707 described concomitant gemcitabine and warfarin. The gemcitabine-warfarin interaction term was significantly positive (interaction reporting odds ratio 1.31, 95% confidence interval 1.07-1.60; p = 0.010) and remained positive in serious reports (1.36, 1.09-1.69; p = 0.006). Interaction-term estimates for direct oral anticoagulants were inconsistent or not robust in sensitivity analyses. Time-to-onset was available for 29 haemorrhagic reports, with a median of 15 days (interquartile range 10-52; range 4-529 days). Positive dechallenge was recorded in 17 reports; no positive rechallenge was recorded. Conclusion: This VigiBase analysis identified disproportionate haemorrhagic-event reporting with concomitant gemcitabine and warfarin. These findings should be interpreted in light of the limitations inherent to spontaneous reporting, including under-reporting, reporting biases, missingness, and residual confounding.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.