PMID- 37974405
OWN - NLM
STAT- Publisher
LR  - 20231120
IS  - 1744-764X (Electronic)
IS  - 1474-0338 (Linking)
DP  - 2023 Nov 16
TI  - Newly identified adverse events for gemcitabine using the Food and Drug 
      Administration Adverse Event Reporting System.
PG  - 1-7
LID - 10.1080/14740338.2023.2284989 [doi]
AB  - BACKGROUND: Our research aimed to identify previously undocumented adverse events 
      (AEs) in the gemcitabine drug insert with the goal of informing clinical 
      practice. METHODS: We extracted adverse events associated with gemcitabine use 
      through 2023 using the Food and Drug Administration Adverse Event Reporting 
      System (FAERS) database. Four algorithms (Reporting Odds Ratio, Proportional 
      Reporting Ratio, Bayesian Confidence Propagation Neural Network, and Empirical 
      Bayesian Geometric Mean) were employed to detect new AE signals. AEs were 
      considered positive signals only if they were detected by all four algorithms. 
      RESULTS: From 2014 to 2023, a total of 42,360 AEs were reported in 14,905 
      individuals following gemcitabine use. These AEs totaled 437 preferred terms 
      (PTs) across 20 system organ classes (SOCs). We identified unexpected AEs related 
      to the ocular disorders, the nervous system, and the ear and the labyrinth. The 
      ocular organ system will present with retinopathy, purtscher retinopathy, 
      choroidal effusion, amaurosis, necrotizing scleritis, etc. The nervous system may 
      experience reversible posterior encephalopathy syndrome, cerebellar syndrome, 
      cauda equina syndrome, athetosis, transverse myelitis, etc. The ears and 
      labyrinth may exhibit ototoxicity. CONCLUSION: Our study identified previously 
      undetected signals following gemcitabine treatment, thereby providing new 
      insights for future medication guidance.
FAU - Zhang, Wei
AU  - Zhang W
AD  - Department of Urology, First Hospital of Shanxi Medical University, Taiyuan, 
      Shanxi, China.
FAU - Wang, Yuhong
AU  - Wang Y
AD  - Shanxi Medical Service Evaluation Center, Department of health management, 
      Taiyuan, Shanxi, China.
FAU - Jiang, Xin
AU  - Jiang X
AD  - Department of Urology, First Hospital of Shanxi Medical University, Taiyuan, 
      Shanxi, China.
FAU - Zhao, Hu
AU  - Zhao H
AD  - Department of Urology, First Hospital of Shanxi Medical University, Taiyuan, 
      Shanxi, China.
FAU - Jia, Xinli
AU  - Jia X
AD  - Department of Urology, First Hospital of Shanxi Medical University, Taiyuan, 
      Shanxi, China.
FAU - Wang, Qiye
AU  - Wang Q
AD  - Department of Urology, First Hospital of Shanxi Medical University, Taiyuan, 
      Shanxi, China.
FAU - Chen, Yue
AU  - Chen Y
AD  - Department of Urology, First Hospital of Shanxi Medical University, Taiyuan, 
      Shanxi, China.
FAU - Jiang, Yuanfang
AU  - Jiang Y
AD  - Department of Urology, First Hospital of Shanxi Medical University, Taiyuan, 
      Shanxi, China.
FAU - Ma, Zhifang
AU  - Ma Z
AD  - Department of Urology, First Hospital of Shanxi Medical University, Taiyuan, 
      Shanxi, China.
FAU - Chang, Lina
AU  - Chang L
AD  - Shanxi Provincial Hospital of Traditional Chinese Medicine, Department of 
      Physician Standardization Training Center, Taiyuan, Shanxi, China.
FAU - Wang, Xin
AU  - Wang X
AD  - Department of Urology, First Hospital of Shanxi Medical University, Taiyuan, 
      Shanxi, China.
LA  - eng
PT  - Journal Article
DEP - 20231116
PL  - England
TA  - Expert Opin Drug Saf
JT  - Expert opinion on drug safety
JID - 101163027
SB  - IM
OTO - NOTNLM
OT  - FAERS
OT  - Gemcitabine
OT  - adverse event
OT  - eye diseases
OT  - nervous system
EDAT- 2023/11/17 15:27
MHDA- 2023/11/17 15:27
CRDT- 2023/11/17 03:40
PHST- 2023/11/17 15:27 [pubmed]
PHST- 2023/11/17 15:27 [medline]
PHST- 2023/11/17 03:40 [entrez]
AID - 10.1080/14740338.2023.2284989 [doi]
PST - aheadofprint
SO  - Expert Opin Drug Saf. 2023 Nov 16:1-7. doi: 10.1080/14740338.2023.2284989.