PMID- 38510044
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20240322
IS  - 2405-8440 (Print)
IS  - 2405-8440 (Electronic)
IS  - 2405-8440 (Linking)
VI  - 10
IP  - 6
DP  - 2024 Mar 30
TI  - Alpelisib-related adverse events: The FDA Adverse Event Reporting System Database 
      (FAERS) pharmacovigilance study.
PG  - e27599
LID - 10.1016/j.heliyon.2024.e27599 [doi]
LID - e27599
AB  - BACKGROUND: Alpelisib was approved for treatment of breast cancer. We assessed 
      the safety signals associated with alpelisib by data mining the FDA 
      pharmacovigilance database. METHODS: Data from the second quarter of 2019 to the 
      fourth quarter of 2022 had been retrieved from the FAERS database. 
      Disproportionality analysis by reporting odds ratio were used to evaluate the 
      potential association between adverse events (AEs) and alpelisib. RESULTS: A 
      total of 5,980,090 reports were extracted, 18,149 of them were chosen with 
      alpelisib as the suspected drug. After combining the same PRIMARYID, 5647 
      patients remained. We observed 10 system organ classes (SOCs) with a reported 
      number >50 and associated with alpelisib as gastrointestinal disorders, general 
      disorders and administration site conditions, metabolism and nutrition disorders, 
      skin and subcutaneous tissue disorders, investigations and neoplasms benign, 
      malignant and unspecified (incl cysts and polyps), immune system disorders, 
      nervous system disorders, psychiatric disorders, eye disorders. The median time 
      to AEs in these patients was 13 days, with an IQR (Interquartile Range) of 7-70 
      days. 61.12% AEs happened within the initial month of alpelisib usage. 
      CONCLUSION: Our study provided a more in-depth and extensive understanding of AEs 
      that may be associated with alpelisib, which will help to reduce the risk of AEs 
      in the clinical treatment of alpelisib. AEs with novel preferred term (PTs) were 
      constipation, dysphagia, diabetic ketoacidosis, feeding disorder, urticaria, eye 
      disorders and vision blurred. 61.12% of cases developed AEs within 30 days after 
      taking alpelisib.
CI  - (c) 2024 The Authors.
FAU - Li, Yun
AU  - Li Y
AD  - Department of Pharmacy, Yueyang Central Hospital, Yueyang, 414000, Hunan, PR 
      China.
FAU - Li, Hang
AU  - Li H
AD  - Department of Pharmacy, The Second Xiangya Hospital, Central South University, 
      Changsha, 410011, Hunan, PR China.
FAU - Xiang, Zhongyuan
AU  - Xiang Z
AD  - Department of Laboratory Medicine, The Second Xiangya Hospital, Central South 
      University, Changsha, 410011, Hunan, PR China.
LA  - eng
PT  - Journal Article
DEP - 20240307
PL  - England
TA  - Heliyon
JT  - Heliyon
JID - 101672560
PMC - PMC10951579
OTO - NOTNLM
OT  - Adverse event
OT  - Alpelisib
OT  - Breast cancer
OT  - FAERS database
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- 2024/03/21 06:43
MHDA- 2024/03/21 06:44
PMCR- 2024/03/07
CRDT- 2024/03/21 03:59
PHST- 2023/10/11 00:00 [received]
PHST- 2024/03/03 00:00 [revised]
PHST- 2024/03/04 00:00 [accepted]
PHST- 2024/03/21 06:44 [medline]
PHST- 2024/03/21 06:43 [pubmed]
PHST- 2024/03/21 03:59 [entrez]
PHST- 2024/03/07 00:00 [pmc-release]
AID - S2405-8440(24)03630-2 [pii]
AID - e27599 [pii]
AID - 10.1016/j.heliyon.2024.e27599 [doi]
PST - epublish
SO  - Heliyon. 2024 Mar 7;10(6):e27599. doi: 10.1016/j.heliyon.2024.e27599. eCollection 
      2024 Mar 30.