PMID- 38464722
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20240312
IS  - 1663-9812 (Print)
IS  - 1663-9812 (Electronic)
IS  - 1663-9812 (Linking)
VI  - 15
DP  - 2024
TI  - A real-world study of antifibrotic drugs-related adverse events based on the 
      United States food and drug administration adverse event reporting system and 
      VigiAccess databases.
PG  - 1310286
LID - 10.3389/fphar.2024.1310286 [doi]
LID - 1310286
AB  - Objectives: This study aims to investigate adverse events (AEs) and adverse drug 
      reactions (ADRs) associated with pirfenidone and nintedanib, two antifibrotic 
      drugs used to treat idiopathic pulmonary fibrosis (IPF). Methods: Reporting odds 
      ratio (ROR) and proportional reporting ratio (PRR) analyses were conducted to 
      assess the association between these drugs and signals at both the preferred term 
      (PT) and system organ class (SOC) levels. Results: 55,949 reports for pirfenidone 
      and 35,884 reports for nintedanib were obtained from the FAERS database. The 
      VigiAccess database provided 37,187 reports for pirfenidone and 23,134 reports 
      for nintedanib. Male patients and individuals over the age of 65 were more likely 
      to report AEs. Gastrointestinal disorders emerged as the most significant signal 
      at SOC level for both drugs. Furthermore, nausea, diarrhoea, and decreased 
      appetite were observed at the PT level. We further identified notable signals, 
      including hemiplegic migraine for pirfenidone and asthenia, constipation, and 
      flatulence for nintedanib, which were previously unknown or underestimated ADRs. 
      Conclusion: This study has identified AEs and ADRs associated with pirfenidone 
      and nintedanib, confirming that the majority of the corresponding label 
      information indicates relative safety. However, it is essential to take 
      unexpected risk signals seriously, necessitating further research to manage the 
      safety profiles of these drugs.
CI  - Copyright (c) 2024 He, Yang, Zhou, Wang and Li.
FAU - He, Menglin
AU  - He M
AD  - Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu, 
      Sichuan, China.
FAU - Yang, Taoran
AU  - Yang T
AD  - Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu, 
      Sichuan, China.
FAU - Zhou, Jian
AU  - Zhou J
AD  - Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu, 
      Sichuan, China.
FAU - Wang, Rurong
AU  - Wang R
AD  - Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu, 
      Sichuan, China.
FAU - Li, Xuehan
AU  - Li X
AD  - Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu, 
      Sichuan, China.
LA  - eng
PT  - Journal Article
DEP - 20240223
PL  - Switzerland
TA  - Front Pharmacol
JT  - Frontiers in pharmacology
JID - 101548923
PMC - PMC10920264
OTO - NOTNLM
OT  - adverse drug reaction
OT  - adverse events
OT  - nintedanib
OT  - pharmacovigilance
OT  - pirfenidone
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- 2024/03/11 06:44
MHDA- 2024/03/11 06:45
PMCR- 2024/02/23
CRDT- 2024/03/11 04:40
PHST- 2023/10/09 00:00 [received]
PHST- 2024/02/08 00:00 [accepted]
PHST- 2024/03/11 06:45 [medline]
PHST- 2024/03/11 06:44 [pubmed]
PHST- 2024/03/11 04:40 [entrez]
PHST- 2024/02/23 00:00 [pmc-release]
AID - 1310286 [pii]
AID - 10.3389/fphar.2024.1310286 [doi]
PST - epublish
SO  - Front Pharmacol. 2024 Feb 23;15:1310286. doi: 10.3389/fphar.2024.1310286. 
      eCollection 2024.