PMID- 36446798
OWN - NLM
STAT- MEDLINE
DCOM- 20221201
LR  - 20230111
IS  - 2045-2322 (Electronic)
IS  - 2045-2322 (Linking)
VI  - 12
IP  - 1
DP  - 2022 Nov 29
TI  - A real-world pharmacovigilance study of FDA adverse event reporting system 
      (FAERS) events for niraparib.
PG  - 20601
LID - 10.1038/s41598-022-23726-4 [doi]
LID - 20601
AB  - Niraparib was approved for the treatment of platinum-sensitive recurrent 
      epithelial ovarian cancer, fallopian tube and primary peritoneal cancer. The 
      authors retrospectively investigated niraparib-related adverse events (AEs) 
      through data mining of the US Food and Drug Administration Adverse Event 
      Reporting System (FAERS). Four algorithms were employed to quantify the signals 
      of niraparib associated AEs, using data from the FAERS between 2017 and 2021. 
      MYSQL 8.0, Navicat Premium 15, Microsoft EXCEL 2019 and the GraphPad Prism 8 were 
      used to conduct statistical analysis. There are 7,238,157 reports collected from 
      the FAERS database, of which 11,701 reports listed niraparib as the 'primary 
      suspected (PS)' drug. A total of 97 significant disproportionality PTs conforming 
      to the four algorithms were simultaneously retained. Unexpected significant AEs 
      such as neuropathy peripheral, photosensitivity reaction, gastrooesophageal 
      reflux disease might also occur. The median onset time of niraparib-associated 
      AEs was 18 days (interquartile range [IQR] 4-66 days), and most of the cases 
      occurred within the first months after niraparib initiation. The study found 
      niraparib-associated AEs and might provide important support for clinical 
      monitoring and risk identification of niraparib.
CI  - (c) 2022. The Author(s).
FAU - Guo, Menglin
AU  - Guo M
AD  - Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong 
      University of Science and Technology, No. 1095 Jiefang Avenue, Wuhan, 430030, 
      China.
FAU - Shu, Yamin
AU  - Shu Y
AD  - Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong 
      University of Science and Technology, No. 1095 Jiefang Avenue, Wuhan, 430030, 
      China.
FAU - Chen, Guosong
AU  - Chen G
AD  - Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong 
      University of Science and Technology, No. 1095 Jiefang Avenue, Wuhan, 430030, 
      China.
FAU - Li, Juan
AU  - Li J
AD  - Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong 
      University of Science and Technology, No. 1095 Jiefang Avenue, Wuhan, 430030, 
      China. lijuan@tjh.tjmu.edu.cn.
FAU - Li, Feie
AU  - Li F
AD  - Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong 
      University of Science and Technology, No. 1095 Jiefang Avenue, Wuhan, 430030, 
      China. lifeie@tjh.tjmu.edu.cn.
LA  - eng
PT  - Journal Article
DEP - 20221129
PL  - England
TA  - Sci Rep
JT  - Scientific reports
JID - 101563288
RN  - HMC2H89N35 (niraparib)
SB  - IM
MH  - United States/epidemiology
MH  - Female
MH  - Humans
MH  - *Pharmacovigilance
MH  - United States Food and Drug Administration
MH  - Retrospective Studies
MH  - Neoplasm Recurrence, Local
MH  - Carcinoma, Ovarian Epithelial
MH  - *Ovarian Neoplasms/drug therapy
PMC - PMC9709073
COIS- The authors declare no competing interests.
EDAT- 2022/11/30 06:00
MHDA- 2022/12/02 06:00
PMCR- 2022/11/29
CRDT- 2022/11/29 23:20
PHST- 2022/07/07 00:00 [received]
PHST- 2022/11/04 00:00 [accepted]
PHST- 2022/11/29 23:20 [entrez]
PHST- 2022/11/30 06:00 [pubmed]
PHST- 2022/12/02 06:00 [medline]
PHST- 2022/11/29 00:00 [pmc-release]
AID - 10.1038/s41598-022-23726-4 [pii]
AID - 23726 [pii]
AID - 10.1038/s41598-022-23726-4 [doi]
PST - epublish
SO  - Sci Rep. 2022 Nov 29;12(1):20601. doi: 10.1038/s41598-022-23726-4.