PMID- 38395895
OWN - NLM
STAT- MEDLINE
DCOM- 20240226
LR  - 20240227
IS  - 2050-6511 (Electronic)
IS  - 2050-6511 (Linking)
VI  - 25
IP  - 1
DP  - 2024 Feb 23
TI  - Pharmacovigilance study of BCR-ABL1 tyrosine kinase inhibitors: a safety analysis 
      of the FDA adverse event reporting system.
PG  - 20
LID - 10.1186/s40360-024-00741-x [doi]
LID - 20
AB  - BACKGROUND: With the increased use of BCR-ABL1 tyrosine kinase inhibitors (TKIs) 
      in cancer patients, adverse events (AEs) have garnered considerable interest. We 
      conducted this pharmacovigilance study to evaluate the AEs of BCR-ABL1 TKIs in 
      cancer patients using the Food and Drug Administration Adverse Event Reporting 
      System (FAERS) database. METHODS: To query AE reports from the FAERS database, we 
      used OpenVigil 2.1. Descriptive analysis was then employed to describe the 
      characteristics of TKIs-associated AE reports. We also utilized the 
      disproportionality analysis to detect safety signals by calculating the 
      proportional reporting ratio (PRR) and reporting odds ratios (ROR). RESULTS: From 
      the FAERS database, a total of 85,989 AE reports were retrieved, with 3,080 
      significant AE signals identified. Specifically, imatinib, nilotinib, dasatinib, 
      bosutinib, and ponatinib had significant AE signals of 1,058, 813, 232, 186, and 
      791, respectively. These significant signals were further categorized into 26 
      system organ classes (SOCs). The AE signals of imatinib and ponatinib were 
      primarily associated with general disorders and administration site conditions. 
      On the other hand, nilotinib, dasatinib, and bosutinib were mainly linked to 
      investigations, respiratory, thoracic and mediastinal disorders, and 
      gastrointestinal disorders, respectively. Notably, new signals of 245, 278, 47, 
      55, and 253 were observed in imatinib, nilotinib, dasatinib, bosutinib, and 
      ponatinib, respectively. CONCLUSIONS: The results of this study demonstrated that 
      AE signals differ among the five BCR-ABL1 TKIs. Furthermore, each BCR-ABL1 TKI 
      displayed several new signals. These findings provide valuable information for 
      clinicians aiming to reduce the risk of AEs during BCR-ABL1 TKI treatment.
CI  - (c) 2024. The Author(s).
FAU - Zhao, Dehua
AU  - Zhao D
AD  - Department of Clinical Pharmacy, The Third Hospital of Mianyang (Sichuan Mental 
      Health Center), 621000, Mianyang, Sichuan, People's Republic of China. 
      zhaoyaoshi0566@163.com.
FAU - Long, Xiaoqing
AU  - Long X
AD  - Department of Clinical Pharmacy, The Third Hospital of Mianyang (Sichuan Mental 
      Health Center), 621000, Mianyang, Sichuan, People's Republic of China.
FAU - Wang, Jisheng
AU  - Wang J
AD  - Department of Clinical Pharmacy, The Third Hospital of Mianyang (Sichuan Mental 
      Health Center), 621000, Mianyang, Sichuan, People's Republic of China. 
      wangjishengyaoshi@163.com.
LA  - eng
PT  - Journal Article
DEP - 20240223
PL  - England
TA  - BMC Pharmacol Toxicol
JT  - BMC pharmacology & toxicology
JID - 101590449
RN  - 8A1O1M485B (Imatinib Mesylate)
RN  - RBZ1571X5H (Dasatinib)
RN  - 5018V4AEZ0 (bosutinib)
RN  - 0 (Tyrosine Kinase Inhibitors)
RN  - 0 (Protein Kinase Inhibitors)
RN  - EC 2.7.10.2 (Fusion Proteins, bcr-abl)
RN  - 0 (Pyrimidines)
RN  - 0 (Aniline Compounds)
RN  - 0 (Nitriles)
RN  - 0 (Quinolines)
SB  - IM
MH  - Humans
MH  - Imatinib Mesylate
MH  - Dasatinib/adverse effects
MH  - *Tyrosine Kinase Inhibitors
MH  - Protein Kinase Inhibitors/therapeutic use
MH  - Pharmacovigilance
MH  - *Leukemia, Myelogenous, Chronic, BCR-ABL Positive/chemically induced/drug therapy
MH  - Fusion Proteins, bcr-abl/therapeutic use
MH  - Pyrimidines/therapeutic use
MH  - *Aniline Compounds
MH  - *Nitriles
MH  - *Quinolines
PMC - PMC10885429
OTO - NOTNLM
OT  - Adverse events
OT  - BCR-ABL1 TKIs
OT  - Disproportionality analysis
OT  - FAERS
OT  - Pharmacovigilance
COIS- The authors declare no competing interests.
EDAT- 2024/02/24 11:42
MHDA- 2024/02/26 06:43
PMCR- 2024/02/23
CRDT- 2024/02/23 23:40
PHST- 2023/06/30 00:00 [received]
PHST- 2024/02/09 00:00 [accepted]
PHST- 2024/02/26 06:43 [medline]
PHST- 2024/02/24 11:42 [pubmed]
PHST- 2024/02/23 23:40 [entrez]
PHST- 2024/02/23 00:00 [pmc-release]
AID - 10.1186/s40360-024-00741-x [pii]
AID - 741 [pii]
AID - 10.1186/s40360-024-00741-x [doi]
PST - epublish
SO  - BMC Pharmacol Toxicol. 2024 Feb 23;25(1):20. doi: 10.1186/s40360-024-00741-x.