ArticleAnnals of hematology2025
A pharmacovigilance study of adverse events associated with polycythemia vera treatments using the FDA Adverse Event Reporting System (FAERS) database.
Article in Annals of hematology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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
2 citing papers in PubMed.
- Contributions of Pharmacovigilance to the Understanding of Risks Associated with Ibuprofen: Descriptive and Disproportionality Analysis Using FAERS Data.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Analysis of ocular adverse events associated with SNRIs.Frontiers in pharmacology · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
Abstract
Cytoreductive therapies remain vital to the management of polycythemia vera (PV). Real-world data are needed to complement clinical trial safety information. We evaluated the safety profiles of four commonly used PV therapies—ropeginterferon alfa-2b (ropeg, on-label), peginterferon alfa-2a (peg-IFN, off-label), ruxolitinib (on-label), and hydroxyurea (HU, off-label)—using the FDA Adverse Event Reporting System (FAERS) database. Among 97,812 adverse event (AE) reports for patients receiving cytoreduction from January 1, 2022, through December 31, 2024, 11,754 were analyzed. HU and peg-IFN showed elevated reporting odds ratios (RORs) for serious adverse events (SAEs), which increased over time for HU (8.55 in 2022, 13.46 in 2023, 16.04 in 2024) and peaked for peg-IFN in 2023 (22.25). Ruxolitinib had ROR > 1 only in 2023 (1.47), while ropeg had no RORs > 1 for SAEs. For fatal AEs, ruxolitinib demonstrated RORs > 1 across multiple years (15.74 in 2022, 5.07 in 2023, 4.47 in 2024), whereas HU, peg-IFN, and ropeg did not. HU and ruxolitinib were associated with higher reporting of blood and lymphatic disorders than ropeg and peg-IFN, while peg-IFN had the highest proportion of cardiac disorder AEs (4.38%). HU (8.24%) and ruxolitinib (2.79%) showed elevated neoplasm-related AE proportions compared with peg-IFN (1.46%) and ropeg (0.65%). Ropeg showed the highest RORs for non-serious AEs. Contrary to clinical trial data, psychiatric disorders were most reported with ropeg (5.79%). An exploratory age-stratified analysis was also performed, though interpretation was limited by missing age data. These real-world findings provide valuable insights into the long-term risk-benefit profiles of cytoreductive therapies in PV and can guide personalized treatment strategies. Further studies are warranted to confirm these observations.
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