PMID- 37536976
OWN - NLM
STAT- MEDLINE
DCOM- 20230807
LR  - 20230808
IS  - 2044-6055 (Electronic)
IS  - 2044-6055 (Linking)
VI  - 13
IP  - 8
DP  - 2023 Aug 3
TI  - Fluid retention-associated adverse events in patients treated with BCR::ABL1 
      inhibitors based on FDA Adverse Event Reporting System (FAERS): a retrospective 
      pharmacovigilance study.
PG  - e071456
LID - 10.1136/bmjopen-2022-071456 [doi]
LID - e071456
AB  - OBJECTIVES: This study aimed to conduct a thorough analysis of fluid 
      retention-associated adverse events (AEs) associated with BCR::ABL inhibitors. 
      DESIGN: A retrospective pharmacovigilance study. SETTING: Food and Drug 
      Administration Adverse Event Reporting System (FAERS) database for BCR::ABL 
      inhibitors was searched from 1 January 2004 to 30 September 2021. MAIN OUTCOME 
      MEASURES: Reporting OR (ROR) and 95% CI were used to detect the signals. ROR was 
      calculated by dividing the odds of fluid retention event reporting for the target 
      drug by the odds of fluid retention event reporting for all other drugs. The 
      signal was considered positive if the lower limit of 95% CI of ROR was >1. The 
      analysis was run only considering coupled fluid retention events/BCR::ABL 
      inhibitors with at least three cases. RESULTS: A total of 97 823 reports were 
      identified in FAERS. Imatinib had the most fluid retention signals, followed by 
      dasatinib and nilotinib, while bosutinib and ponatinib had fewer signals. 
      Periorbital oedema (ROR=24.931, 95% CI 22.404 to 27.743), chylothorax 
      (ROR=161.427, 95% CI 125.835 to 207.085), nipple swelling (ROR=48.796, 95% CI 
      26.270 to 90.636), chylothorax (ROR=35.798, 95% CI 14.791 to 86.642) and 
      gallbladder oedema (ROR=77.996, 95% CI 38.286 to 158.893) were the strongest 
      signals detected for imatinib, dasatinib, nilotinib, bosutinib and ponatinib, 
      respectively. Pleural effusion, pericardial effusion and pulmonary oedema were 
      detected for all BCR::ABL inhibitors, with dasatinib having the highest RORs for 
      pleural effusion (ROR=37.424, 95% CI 35.715 to 39.216), pericardial effusion 
      (ROR=14.146, 95% CI 12.649 to 15.819) and pulmonary oedema (ROR=11.217, 95% CI 
      10.303 to 12.213). Patients aged >/=65 years using dasatinib, imatinib, nilotinib 
      or bosutinib had higher RORs for pleural effusion, pericardial effusion and 
      pulmonary oedema. Patients aged >/=65 years and females using imatinib had higher 
      RORs for periorbital oedema, generalised oedema and face oedema. CONCLUSIONS: 
      This pharmacovigilance study serves as a clinical reminder to physicians to be 
      more vigilant for fluid retention-associated AEs with BCR::ABL inhibitors.
CI  - (c) Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No 
      commercial re-use. See rights and permissions. Published by BMJ.
FAU - Huang, Jing
AU  - Huang J
AD  - Department of Pharmacy, The First Affiliated Hospital of Ningbo University, 
      Ningbo, Zhejiang, China.
FAU - Cai, Juanjuan
AU  - Cai J
AD  - Department of Pharmacy, The First Affiliated Hospital of Ningbo University, 
      Ningbo, Zhejiang, China.
FAU - Ye, Qingqing
AU  - Ye Q
AD  - Department of Pharmacy, The First Affiliated Hospital of Ningbo University, 
      Ningbo, Zhejiang, China.
FAU - Jiang, Qiaoying
AU  - Jiang Q
AD  - Department of Pharmacy, The First Affiliated Hospital of Ningbo University, 
      Ningbo, Zhejiang, China.
FAU - Lin, Huan
AU  - Lin H
AD  - Department of Pharmacy, The First Affiliated Hospital of Ningbo University, 
      Ningbo, Zhejiang, China.
FAU - Wu, Lun
AU  - Wu L
AUID- ORCID: 0000-0001-8478-9384
AD  - Department of Pharmacy, The First Affiliated Hospital of Ningbo University, 
      Ningbo, Zhejiang, China fywulun@nbu.edu.cn.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20230803
PL  - England
TA  - BMJ Open
JT  - BMJ open
JID - 101552874
RN  - RBZ1571X5H (Dasatinib)
RN  - 8A1O1M485B (Imatinib Mesylate)
RN  - 5018V4AEZ0 (bosutinib)
RN  - 0 (Pyrimidines)
SB  - IM
MH  - Female
MH  - Humans
MH  - United States/epidemiology
MH  - Dasatinib
MH  - Imatinib Mesylate
MH  - Pharmacovigilance
MH  - *Pulmonary Edema/chemically induced
MH  - Retrospective Studies
MH  - *Chylothorax/chemically induced/drug therapy
MH  - *Pericardial Effusion/chemically induced/drug therapy
MH  - Pyrimidines/therapeutic use
MH  - *Pleural Effusion/chemically induced
MH  - Adverse Drug Reaction Reporting Systems
MH  - United States Food and Drug Administration
PMC - PMC10401248
OTO - NOTNLM
OT  - CLINICAL PHARMACOLOGY
OT  - Leukaemia
OT  - ONCOLOGY
COIS- Competing interests: None declared.
EDAT- 2023/08/04 01:07
MHDA- 2023/08/07 06:42
PMCR- 2023/08/03
CRDT- 2023/08/03 21:38
PHST- 2023/08/07 06:42 [medline]
PHST- 2023/08/04 01:07 [pubmed]
PHST- 2023/08/03 21:38 [entrez]
PHST- 2023/08/03 00:00 [pmc-release]
AID - bmjopen-2022-071456 [pii]
AID - 10.1136/bmjopen-2022-071456 [doi]
PST - epublish
SO  - BMJ Open. 2023 Aug 3;13(8):e071456. doi: 10.1136/bmjopen-2022-071456.