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Novel insights into post-marketing adverse events associated with lenvatinib: A comprehensive analysis utilizing the
Zhe Yu1, Jing Luo1, Hongshan Wei1,2
1Peking University Ditan Teaching Hospital, Beijing, 100015, China.
Purpose:
The primary aim of this study was to closely monitor and identify adverse events (AEs) linked to lenvatinib, a pharmacotherapeutic agent employed for the management of renal cell carcinoma, thyroid cancer, and hepatocellular carcinoma. The ultimate goal was to optimize patient safety and provide evidence-based guidance for the appropriate utilization of this medication.
Methods:
A comprehensive collection and analysis of reports from the FDA Adverse Event Reporting System (FAERS) database was conducted, encompassing the period from the first quarter of 2015 to the first quarter of 2023. Disproportionality analysis, employing robust algorithms including ROR, PRR, BCPNN, and EBGM was employed for effective data mining to quantify signals associated with lenvatinib-related AEs.
Results:
Among the collected reports, a total of 15,193 cases were identified where lenvatinib was the "primary suspected (PS)" drug, resulting in 50,508 lenvatinib-induced AEs. An analysis was conducted to examine the occurrence of lenvatinib-induced adverse drug reactions (ADRs) across 26 organ systems. The findings revealed the presence of expected ADRs, including diarrhea, vomiting, stomatitis, hepatic encephalopathy, decreased appetite, dehydration, decreased weight, and electrolyte imbalances, which were consistent with the information provided in the drug labels. Furthermore, unexpected significant ADRs were observed at the preferred terms (PT) level, such as interstitial lung disease, pneumothorax, hypophysitis, failure to thrive, polycythemia, hypopituitarism, spontaneous pneumothorax, pulmonary cavitation, and limbic encephalitis. These findings indicated the potential occurrence of adverse effects that are currently not documented in the drug instructions.
Conclusions:
This study has successfully detected novel and unforeseen signals pertaining to ADRs associated with the administration of lenvatinib, thereby contributing significant insights into the intricate correlation between ADRs and the utilization of lenvatinib. The outcomes of this investigation underscore the utmost significance of continuous monitoring and vigilant surveillance in order to promptly identify and effectively manage AEs, consequently enhancing overall patient safety and well-being in the context of lenvatinib therapy.
Insights
This study identified new adverse drug reactions (ADRs) associated with lenvatinib, a cancer drug. Continuous monitoring is crucial for patient safety and effective management of lenvatinib therapy.
Area of Science:
- Pharmacovigilance
- Oncology
- Drug Safety
Background:
- Lenvatinib is a multi-targeted kinase inhibitor used for renal cell carcinoma, thyroid cancer, and hepatocellular carcinoma.
- Monitoring adverse events (AEs) is critical for optimizing patient safety during lenvatinib therapy.
Purpose of the Study:
- To identify and monitor adverse events (AEs) associated with lenvatinib.
- To provide evidence-based guidance for the safe and effective use of lenvatinib.
Main Methods:
- Analysis of FDA Adverse Event Reporting System (FAERS) database from Q1 2015 to Q1 2023.
- Disproportionality analysis using ROR, PRR, BCPNN, and EBGM algorithms to detect safety signals.
- Examination of lenvatinib-induced adverse drug reactions (ADRs) across 26 organ systems.
Main Results:
- 15,193 cases identified with lenvatinib as the primary suspected drug, leading to 50,508 AEs.
- Expected ADRs like diarrhea, vomiting, and decreased appetite were confirmed.
- Unexpected significant ADRs included interstitial lung disease, pneumothorax, hypophysitis, and limbic encephalitis.
Conclusions:
- Novel and unforeseen ADR signals associated with lenvatinib were detected.
- Findings contribute to understanding the complex relationship between lenvatinib use and ADRs.
- Continuous pharmacovigilance is essential for prompt AE identification and management, enhancing patient safety.
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