A real-world data analysis of topotecan in the FDA Adverse Event Reporting System (FAERS) database
Haiyan Yang1, Zheng Wan2, Moliang Chen3,4
1Department of Gynecological Oncology, The Fourth Affiliated Hospital of Guangxi Medical University, Liuzhou, China.
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.
Insights
This study monitored adverse events (AEs) for topotecan, a cancer drug. Unexpected eye disorder risks were identified, enhancing patient safety and guiding medication use.
Area of Science:
- Pharmacovigilance
- Oncology
- Drug Safety
Background:
- Topotecan is a key treatment for solid tumors.
- Monitoring adverse events (AEs) is crucial for patient safety.
- Real-world data analysis aids in identifying drug-associated risks.
Purpose of the Study:
- To monitor and identify adverse events (AEs) associated with topotecan.
- To improve patient safety and guide topotecan medication usage.
- To assess disproportionality of topotecan-related AEs using real-world data.
Main Methods:
- Utilized four algorithms (ROR, PRR, BCPNN, EBGM) for AE signal detection.
- Analyzed 9,511,161 case reports from the FAERS database (2004Q1-2021Q4).
- Focused on 1,896 primary suspected (PS) AEs and 155 topotecan-related adverse drug reactions (ADRs) at the preferred terms (PTs) level across 23 organ systems.
Main Results:
- Identified expected ADRs like anemia, nausea, and vomiting, consistent with drug labels.
- Discovered unexpected significant ADRs in eye disorders at the system organ class (SOC) level.
- Confirmed 1,896 primary suspected AEs and 155 ADRs related to topotecan.
Conclusions:
- Identified new, unexpected adverse drug reactions (ADRs) linked to topotecan.
- Findings provide valuable insights into topotecan-associated ADRs.
- Emphasizes the importance of ongoing pharmacovigilance for topotecan safety.
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