PMID- 38533254
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20240328
IS  - 1663-9812 (Print)
IS  - 1663-9812 (Electronic)
IS  - 1663-9812 (Linking)
VI  - 15
DP  - 2024
TI  - A real-world disproportionality analysis of Everolimus: data mining of the public 
      version of FDA adverse event reporting system.
PG  - 1333662
LID - 10.3389/fphar.2024.1333662 [doi]
LID - 1333662
AB  - Background: Everolimus is an inhibitor of the mammalian target of rapamycin and 
      is used to treat various tumors. The presented study aimed to evaluate the 
      Everolimus-associated adverse events (AEs) through data mining of the US Food and 
      Drug Administration Adverse Event Reporting System (FAERS). Methods: The AE 
      records were selected by searching the FDA Adverse Event Reporting System 
      database from the first quarter of 2009 to the first quarter of 2022. Potential 
      adverse event signals were mined using the disproportionality analysis, including 
      reporting odds ratio the proportional reporting ratio the Bayesian confidence 
      propagation neural network and the empirical Bayes geometric mean and MedDRA was 
      used to systematically classify the results. Results: A total of 24,575 AE 
      reports of Everolimus were obtained using data from the FAERS database, and 
      Everolimus-induced AEs occurrence targeted 24 system organ classes after 
      conforming to the four algorithms simultaneously. The common significant SOCs 
      were identified, included benign, malignant and unspecified neoplasms, 
      reproductive system and breast disorders, etc. The significant AEs were then 
      mapped to preferred terms such as stomatitis, pneumonitis and impaired insulin 
      secretion, which have emerged in the study usually reported in patients with 
      Everolimus. Of note, unexpected significant AEs, including biliary ischaemia, 
      angiofibroma, and tuberous sclerosis complex were uncovered in the label. 
      Conclusion: This study provided novel insights into the monitoring, surveillance, 
      and management of adverse drug reaction associated with Everolimus. The outcome 
      of serious adverse events and the corresponding detection signals, as well as the 
      unexpected significant adverse events signals are worthy of attention in order to 
      improving clinical medication safety during treatment of Everolimus.
CI  - Copyright (c) 2024 Zhao, Fu, Cui, Chen, Liu and Luo.
FAU - Zhao, Bin
AU  - Zhao B
AD  - Xiamen Health and Medical Big Data Center, Xiamen, China.
AD  - Xiamen Medicine Research Institute, Xiamen, China.
FAU - Fu, Yumei
AU  - Fu Y
AD  - Department of Breast Surgery, The Affiliated Hospital of Guizhou Medical 
      University, Guiyang, China.
FAU - Cui, Shichao
AU  - Cui S
AD  - NHC Key Laboratory of Male Reproduction and Genetics, Guangdong Provincial 
      Reproductive Science Institute (Guangdong Provincial Fertility Hospital), 
      Guangzhou, China.
FAU - Chen, Xiangning
AU  - Chen X
AD  - Department of Medical Quality Control, Sun Yat-sen University Cancer Center, 
      Guangzhou, China.
FAU - Liu, Shu
AU  - Liu S
AD  - Department of Breast Surgery, The Affiliated Hospital of Guizhou Medical 
      University, Guiyang, China.
FAU - Luo, Lan
AU  - Luo L
AD  - Department of Breast Surgery, The Affiliated Hospital of Guizhou Medical 
      University, Guiyang, China.
LA  - eng
PT  - Journal Article
DEP - 20240312
PL  - Switzerland
TA  - Front Pharmacol
JT  - Frontiers in pharmacology
JID - 101548923
PMC - PMC10964017
OTO - NOTNLM
OT  - Everolimus
OT  - FAERS
OT  - adverse event
OT  - data mining
OT  - pharmacovigilance
COIS- The authors declare that the research was conducted in the absence of any 
      commercial or financial relationships that could be construed as a potential 
      conflict of interest.
EDAT- 2024/03/27 06:44
MHDA- 2024/03/27 06:45
PMCR- 2024/03/12
CRDT- 2024/03/27 03:53
PHST- 2023/11/05 00:00 [received]
PHST- 2024/02/16 00:00 [accepted]
PHST- 2024/03/27 06:45 [medline]
PHST- 2024/03/27 06:44 [pubmed]
PHST- 2024/03/27 03:53 [entrez]
PHST- 2024/03/12 00:00 [pmc-release]
AID - 1333662 [pii]
AID - 10.3389/fphar.2024.1333662 [doi]
PST - epublish
SO  - Front Pharmacol. 2024 Mar 12;15:1333662. doi: 10.3389/fphar.2024.1333662. 
      eCollection 2024.