PMID- 37243615
OWN - NLM
STAT- MEDLINE
DCOM- 20230619
LR  - 20230619
IS  - 1744-7607 (Electronic)
IS  - 1742-5255 (Linking)
VI  - 19
IP  - 4
DP  - 2023 Apr
TI  - A real-world data analysis of topotecan in the FDA Adverse Event Reporting System 
      (FAERS) database.
PG  - 217-223
LID - 10.1080/17425255.2023.2219390 [doi]
AB  - OBJECTIVES: The objective of this study was to monitor and identify adverse 
      events (AEs) associated with topotecan, a medication used for the treatment of 
      solid tumors, in order to improve patient safety and guide medication usage. 
      METHODS: To assess the disproportionality of topotecan-related AEs in real-world 
      data, four algorithms (ROR, PRR, BCPNN, and EBGM) were employed as measures to 
      detect signals of topotecan-associated AEs. RESULTS: A statistical analysis was 
      conducted using data from the FAERS database, encompassing 9,511,161 case reports 
      from 2004Q1 to 2021Q4. Among these reports, 1,896 were identified as primary 
      suspected (PS) AEs related to topotecan, and 155 topotecan-related adverse drug 
      reactions (ADRs) at the preferred terms (PTs) level were selected. The occurrence 
      of topotecan-induced ADRs was analyzed across 23 organ systems. The analysis 
      revealed several expected ADRs, such as anemia, nausea, and vomiting, which were 
      consistent with the drug labels. Additionally, unexpected significant ADRs 
      associated with eye disorders at the system organ class (SOC) level were 
      identified, indicating potential adverse effects not currently mentioned in the 
      drug instructions. CONCLUSION: This study identified new and unexpected signals 
      of adverse drug reactions (ADRs) related to topotecan, providing valuable 
      insights into the relationship between ADRs and topotecan usage. The findings 
      highlight the importance of ongoing monitoring and surveillance to detect and 
      manage AEs effectively, ultimately improving patient safety during topotecan 
      treatment.
FAU - Yang, Haiyan
AU  - Yang H
AD  - Department of Gynecological Oncology, The Fourth Affiliated Hospital of Guangxi 
      Medical University, Liuzhou, China.
FAU - Wan, Zheng
AU  - Wan Z
AD  - Department of Minimally Invasive and Interventional Therapy for Cancer, Zhongshan 
      Hospital, Xiamen University, Xiamen, China.
FAU - Chen, Moliang
AU  - Chen M
AD  - Xiamen Health and Medical Big Data Center, Xiamen, China.
AD  - Xiamen Medicine Research Institute, Xiamen, China.
FAU - Zhang, Xiaohong
AU  - Zhang X
AD  - Department of Pathology, The 909th Hospital, School of Medicine, Xiamen 
      University, China.
FAU - Cui, Wugeng
AU  - Cui W
AD  - Department of Pharmacology, School of Medical Science, Ningbo University, Ningbo, 
      China.
FAU - Zhao, Bin
AU  - Zhao B
AUID- ORCID: 0000-0002-8165-3315
AD  - Xiamen Health and Medical Big Data Center, Xiamen, China.
AD  - Xiamen Medicine Research Institute, Xiamen, China.
LA  - eng
PT  - Journal Article
DEP - 20230530
PL  - England
TA  - Expert Opin Drug Metab Toxicol
JT  - Expert opinion on drug metabolism & toxicology
JID - 101228422
RN  - 7M7YKX2N15 (Topotecan)
SB  - IM
MH  - Humans
MH  - United States
MH  - *Adverse Drug Reaction Reporting Systems
MH  - Topotecan/adverse effects
MH  - Databases, Factual
MH  - *Drug-Related Side Effects and Adverse Reactions/epidemiology
MH  - United States Food and Drug Administration
MH  - Data Analysis
OTO - NOTNLM
OT  - BCPNN
OT  - EBGM
OT  - PRR
OT  - ROR
OT  - Topotecan
EDAT- 2023/05/27 19:14
MHDA- 2023/06/19 13:08
CRDT- 2023/05/27 14:54
PHST- 2023/06/19 13:08 [medline]
PHST- 2023/05/27 19:14 [pubmed]
PHST- 2023/05/27 14:54 [entrez]
AID - 10.1080/17425255.2023.2219390 [doi]
PST - ppublish
SO  - Expert Opin Drug Metab Toxicol. 2023 Apr;19(4):217-223. doi: 
      10.1080/17425255.2023.2219390. Epub 2023 May 30.