PMID- 37554985
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230810
IS  - 1663-9812 (Print)
IS  - 1663-9812 (Electronic)
IS  - 1663-9812 (Linking)
VI  - 14
DP  - 2023
TI  - Safety analysis of pemigatinib leveraging the US Food and Drug administration 
      adverse event reporting system.
PG  - 1194545
LID - 10.3389/fphar.2023.1194545 [doi]
LID - 1194545
AB  - Background: Cholangiocarcinoma (CCA) is a highly lethal and aggressive epithelial 
      tumor of the hepatobiliary system. A poor prognosis, propensity for relapse, low 
      chance of cure and survival are some of its hallmarks. Pemigatinib, the first 
      targeted treatment for CCA in the United States, has been demonstrated to have a 
      significant response rate and encouraging survival data in early-phase trials. 
      The adverse events (AEs) of pemigatinib must also be determined. Objective: To 
      understand more deeply the safety of pemigatinib in the real world through 
      data-mining of the US Food and Drug Administration (FDA) Adverse Event Reporting 
      System (FAERS). Methods: Disproportionality analysis was employed in a 
      retrospective pharmacovigilance investigation to identify the AEs linked to 
      pemigatinib use as signals. Data were collected between 1 January 2020 to 30 June 
      2022. Four data-mining methods (proportional reporting odds ratio; proportional 
      reporting ratio; Bayesian confidence propagation neural networks of information 
      components; empirical Bayes geometric means) were used to calculate 
      disproportionality. Results: A total of 203 cases using pemigatinib as the 
      prime-suspect medication were found in our search, which involved 99 preferred 
      terms (PTs). Thirteen signals of pemigatinib-induced AEs in seven System Organ 
      Classes were detected after confirming the four algorithms simultaneously. 
      Nephrolithiasis was an unexpected significant AE not listed on the drug label 
      found in our data-mining. Comparison of the differences between pemigatinib and 
      platinum drugs in terms of 33 PTs revealed that 13 PTs also met the criteria of 
      the four algorithms. Ten of these PTs were identical to those compared with all 
      other drugs, in which (excluding a reduction in phosphorus in blood) other PT 
      signal values were higher than those of all other drugs tested. However, 
      comparison of the differences between pemigatinib and infigratinib in terms of 
      the 33 PTs revealed no significant signals in each algorithm method. Conclusion: 
      Some significant signals were detected between pemigatinib use and AEs. PTs with 
      apparently strong signals and PTs not mentioned in the label should be taken 
      seriously.
CI  - Copyright (c) 2023 Zhang, Ran, Liang, Zhang and An.
FAU - Zhang, Ying
AU  - Zhang Y
AD  - Department of Pharmacy, Beijing Chao-Yang Hospital, Capital Medical University, 
      Beijing, China.
FAU - Ran, Li
AU  - Ran L
AD  - Department of Pharmacy, Beijing Chao-Yang Hospital, Capital Medical University, 
      Beijing, China.
FAU - Liang, Yongchao
AU  - Liang Y
AD  - Department of Pharmacy, Beijing Chao-Yang Hospital, Capital Medical University, 
      Beijing, China.
FAU - Zhang, Yanqiu
AU  - Zhang Y
AD  - Department of Pharmacy, Beijing Chao-Yang Hospital, Capital Medical University, 
      Beijing, China.
FAU - An, Zhuoling
AU  - An Z
AD  - Department of Pharmacy, Beijing Chao-Yang Hospital, Capital Medical University, 
      Beijing, China.
LA  - eng
PT  - Journal Article
DEP - 20230724
PL  - Switzerland
TA  - Front Pharmacol
JT  - Frontiers in pharmacology
JID - 101548923
PMC - PMC10405447
OTO - NOTNLM
OT  - Advers drug events
OT  - Food and Drug Administration adverse event reporting system
OT  - disproportionality analysis
OT  - pemigatinib
OT  - real-word study
COIS- The authors declare that the research was conducted in the absence of any 
      commercial or financial relationships that could be construed as a potential 
      conflict of interest.
EDAT- 2023/08/09 06:43
MHDA- 2023/08/09 06:44
PMCR- 2023/07/24
CRDT- 2023/08/09 04:08
PHST- 2023/03/27 00:00 [received]
PHST- 2023/07/10 00:00 [accepted]
PHST- 2023/08/09 06:44 [medline]
PHST- 2023/08/09 06:43 [pubmed]
PHST- 2023/08/09 04:08 [entrez]
PHST- 2023/07/24 00:00 [pmc-release]
AID - 1194545 [pii]
AID - 10.3389/fphar.2023.1194545 [doi]
PST - epublish
SO  - Front Pharmacol. 2023 Jul 24;14:1194545. doi: 10.3389/fphar.2023.1194545. 
      eCollection 2023.