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author:

Zhang, Huiling (Zhang, Huiling.) [1] | Huang, Yaping (Huang, Yaping.) [2] | Ke, Chengjie (Ke, Chengjie.) [3] | Chen, Maohua (Chen, Maohua.) [4]

Indexed by:

SCIE

Abstract:

Introduction Pacritinib, a selective Janus kinase (JAK) inhibitor, is approved for the treatment of myelofibrosis in adults with severe thrombocytopenia. However, its safety profile in real-world populations remains unclear. The aim of study is provided a comprehensive profile of pacritinib's safety by evaluating the adverse events (AEs) using a real-world pharmacovigilance database.Methods Data from the FDA Adverse Event Reporting System (FAERS) database, spanning from the first quarter of 2022 to the second quarter of 2024, served as the basis for this analysis. To identify potential AE risk signals, several disproportionality analysis methods were applied, including the reporting odds ratio, the proportional reporting ratio, the multi-item gamma Poisson shrinker, and the Bayesian confidence propagation neural network.Results A total of 4,304,335 AE reports were collected from the FAERS, with 1,940 reports identifying pacritinib as the primary suspect drug. Significant disproportionality was observed in the following system organ classes: gastrointestinal disorders, investigations, and surgical and medical procedures. Common preferred terms were identified, including diarrhea, fatigue, death, nausea, platelet count decreased, and hemoglobin decreased. Notably, 26 off-label AEs were also identified.Discussion Our study would provide valuable insights for the post-marketing safety surveillance and assessment of pacritinib, and guide its clinical practice.

Keyword:

adverse event disproportionality analysis FAERS pacritinib real-world study

Community:

  • [ 1 ] [Zhang, Huiling]First Peoples Hosp Nanning, Dept Pharm, Nanning, Peoples R China
  • [ 2 ] [Huang, Yaping]Fuzhou Univ, Fujian Med Univ, Fujian Prov Hosp,Affiliated Prov Hosp, Dept Pharm,Shengli Clin Med Coll, Fuzhou, Fujian, Peoples R China
  • [ 3 ] [Ke, Chengjie]Fujian Med Univ, Affiliated Hosp 1, Dept Pharm, Fuzhou, Peoples R China
  • [ 4 ] [Ke, Chengjie]Fujian Med Univ, Affiliated Hosp 1, Natl Reg Med Ctr, Dept Pharm, Binhai Campus, Fuzhou, Peoples R China
  • [ 5 ] [Chen, Maohua]Pingtan Comprehens Expt Area Hosp, Dept Pharm, Fuzhou, Peoples R China

Reprint 's Address:

  • [Ke, Chengjie]Fujian Med Univ, Affiliated Hosp 1, Dept Pharm, Fuzhou, Peoples R China;;[Ke, Chengjie]Fujian Med Univ, Affiliated Hosp 1, Natl Reg Med Ctr, Dept Pharm, Binhai Campus, Fuzhou, Peoples R China;;[Chen, Maohua]Pingtan Comprehens Expt Area Hosp, Dept Pharm, Fuzhou, Peoples R China

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Source :

FRONTIERS IN ONCOLOGY

ISSN: 2234-943X

Year: 2025

Volume: 15

3 . 5 0 0

JCR@2023

Cited Count:

WoS CC Cited Count:

SCOPUS Cited Count:

ESI Highly Cited Papers on the List: 0 Unfold All

WanFang Cited Count:

Chinese Cited Count:

30 Days PV: 3

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