PMID- 38524578
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20240326
IS  - 2405-8440 (Print)
IS  - 2405-8440 (Electronic)
IS  - 2405-8440 (Linking)
VI  - 10
IP  - 6
DP  - 2024 Mar 30
TI  - Novel insights into post-marketing adverse events associated with lenvatinib: A 
      comprehensive analysis utilizing the FAERS database.
PG  - e28132
LID - 10.1016/j.heliyon.2024.e28132 [doi]
LID - e28132
AB  - 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.
CI  - (c) 2024 The Authors.
FAU - Yu, Zhe
AU  - Yu Z
AD  - Peking University Ditan Teaching Hospital, Beijing, 100015, China.
FAU - Luo, Jing
AU  - Luo J
AD  - Peking University Ditan Teaching Hospital, Beijing, 100015, China.
FAU - Wei, Hongshan
AU  - Wei H
AD  - Peking University Ditan Teaching Hospital, Beijing, 100015, China.
AD  - Department of Gastroenterology, Beijing Ditan Hospital, Capital Medical 
      University, Beijing, 100015, China.
LA  - eng
PT  - Journal Article
DEP - 20240313
PL  - England
TA  - Heliyon
JT  - Heliyon
JID - 101672560
PMC - PMC10958715
OTO - NOTNLM
OT  - BCPNN
OT  - EBGM
OT  - PRR
OT  - ROR
OT  - lenvatinib
COIS- The authors declare that they have no known competing financial interests or 
      personal relationships that could have appeared to influence the work reported in 
      this paper.
EDAT- 2024/03/25 06:44
MHDA- 2024/03/25 06:45
PMCR- 2024/03/13
CRDT- 2024/03/25 04:27
PHST- 2023/08/31 00:00 [received]
PHST- 2024/01/26 00:00 [revised]
PHST- 2024/03/12 00:00 [accepted]
PHST- 2024/03/25 06:45 [medline]
PHST- 2024/03/25 06:44 [pubmed]
PHST- 2024/03/25 04:27 [entrez]
PHST- 2024/03/13 00:00 [pmc-release]
AID - S2405-8440(24)04163-X [pii]
AID - e28132 [pii]
AID - 10.1016/j.heliyon.2024.e28132 [doi]
PST - epublish
SO  - Heliyon. 2024 Mar 13;10(6):e28132. doi: 10.1016/j.heliyon.2024.e28132. 
      eCollection 2024 Mar 30.