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# Gemcitabine regimens show consistent myelosuppression signals in FDA adverse-event reports
- URL: https://www.coios.me/gemcitabine-regimens-show-consistent-myelosuppression/
- Published: 2026-09-28T05:40:12.000Z
- Updated: 2026-09-28T07:10:12.000Z
- Description: A disproportionality analysis of 18.37 million FAERS reports from 2014 to 2026 found myelosuppression the most consistent adverse-event signal across gemcitabine regimens for biliary and pancreatic cancer (reporting odds ratios 3.35 to 7.74), with liver-toxicity signals unstable on restriction.
- Author: Daniel Ryan
- Tags: Healthcare today, Cancer, United States, #preprint, #new, #item, #source-2026-09

The authors applied four disproportionality metrics to FDA Adverse Event Reporting System data covering 2014 to 2026 (18.37 million reports), across five gemcitabine exposure groups relevant to biliary tract cancer and pancreatic ductal adenocarcinoma. Myelosuppression was the most consistent signal (ROR 3.35 to 7.74), and thrombocytopenia in the disease-specific subset had an ROR of 19.36, reproduced at 19.70 after deduplication. The triple-combination liver toxicity signal (ROR 10.32) collapsed to 1.62 with zero cases when restricted to primary-suspect reports.

*Why it is interesting: A worked example of how fragile spontaneous-reporting signals are once case definitions are restricted, in a cancer setting where toxicity bears on treatment tolerability.*

Source

[medRxiv, 27 September 2026](https://doi.org/10.64898/2026.09.24.26363686?ref=coios.me)

DOI

10.64898/2026.09.24.26363686

Type

Preprint

Design

Disproportionality analysis (ROR, PRR, IC, EBGM) of FAERS spontaneous reports, 2014-2026, 18.37M reports

Verdict

New finding

Driver

[Cancer](https://www.coios.me/d-cancer/)