PMID- 38327980
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20240210
IS  - 1663-9812 (Print)
IS  - 1663-9812 (Electronic)
IS  - 1663-9812 (Linking)
VI  - 15
DP  - 2024
TI  - A real-world pharmacovigilance study of FDA adverse event reporting system events 
      for diazepam.
PG  - 1278442
LID - 10.3389/fphar.2024.1278442 [doi]
LID - 1278442
AB  - Background: Diazepam, one of the benzodiazepines, is widely used clinically to 
      treat anxiety, for termination of epilepsy, and for sedation. However, the 
      reports of its adverse events (AEs) have been numerous, and even fatal 
      complications have been reported. In this study, we investigated the AEs of 
      diazepam based on real data from the U.S. Food and Drug Administration (FDA) 
      adverse event reporting system (FAERS). Methods: Disproportionality in 
      diazepam-associated AEs was assessed through the calculation of reporting odds 
      ratios (RORs), proportional reporting ratios (PRRs), Bayesian 
      confidence-propagation neural networks (BCPNNs), and gamma-Poisson shrinkage 
      (GPS). Results: Among the 19,514,140 case reports in the FAERS database, 15,546 
      reports with diazepam as the "principal suspect (PS)" AEs were identified. 
      Diazepam-induced AEs occurred targeting 27 system organ categories (SOCs). Based 
      on four algorithms, a total of 391 major disproportionate preferred terms (PTs) 
      were filtered out. Unexpectedly significant AEs such as congenital nystagmus, 
      developmental delays, and rhabdomyolysis were noted, which were not mentioned in 
      the drug insert. Conclusion: Our study identified potential signals of new AEs 
      that could provide strong support for clinical monitoring and risk identification 
      of diazepam.
CI  - Copyright (c) 2024 He, Wang and Chen.
FAU - He, Weizhen
AU  - He W
AD  - Department of Neurosurgery, Xiang'an Hospital of Xiamen University, Xia Men, 
      Fujian, China.
FAU - Wang, Yang
AU  - Wang Y
AD  - Department of Ear Nose and Throat, Xiang'an Hospital of Xiamen University, Xia 
      Men, Fujian, China.
FAU - Chen, Kaiqin
AU  - Chen K
AD  - Department of Neurosurgery, Xiang'an Hospital of Xiamen University, Xia Men, 
      Fujian, China.
LA  - eng
PT  - Journal Article
DEP - 20240124
PL  - Switzerland
TA  - Front Pharmacol
JT  - Frontiers in pharmacology
JID - 101548923
PMC - PMC10847318
OTO - NOTNLM
OT  - adverse event
OT  - diazepam
OT  - disproportionality analysis
OT  - pharmacovigilance
OT  - real-world data analysis
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- 2024/02/08 06:42
MHDA- 2024/02/08 06:43
PMCR- 2024/01/24
CRDT- 2024/02/08 04:13
PHST- 2023/08/16 00:00 [received]
PHST- 2024/01/08 00:00 [accepted]
PHST- 2024/02/08 06:43 [medline]
PHST- 2024/02/08 06:42 [pubmed]
PHST- 2024/02/08 04:13 [entrez]
PHST- 2024/01/24 00:00 [pmc-release]
AID - 1278442 [pii]
AID - 10.3389/fphar.2024.1278442 [doi]
PST - epublish
SO  - Front Pharmacol. 2024 Jan 24;15:1278442. doi: 10.3389/fphar.2024.1278442. 
      eCollection 2024.