PMID- 37581403
OWN - NLM
STAT- MEDLINE
DCOM- 20240214
LR  - 20240214
IS  - 1744-764X (Electronic)
IS  - 1474-0338 (Linking)
VI  - 23
IP  - 2
DP  - 2024 Feb
TI  - A pharmacovigilance study of adverse event profiles and haemorrhagic safety of 
      bevacizumab based on the FAERS database.
PG  - 213-220
LID - 10.1080/14740338.2023.2248876 [doi]
AB  - BACKGROUND: Bevacizumab is used for the treatment of advanced malignant tumors; 
      it acts by inhibiting angiogenesis. This study aimed to examine adverse events 
      (AEs) of bevacizumab, especially hemorrhage, using the Food and Drug 
      Administration Adverse Event Reporting System (FAERS) database. RESEARCH DESIGN 
      AND METHODS: The reporting odds ratio (ROR) and proportional reporting ratio 
      (PRR) were used to analyze the AEs of bevacizumab using FAERS registration data 
      from January 2004 to September 2022. Clinical information regarding hemorrhagic 
      signals was further analyzed. RESULTS: The number of bevacizumab-associated AE 
      reports was 96,477. Our study found that 892 significant preferred terms (PTs) 
      were spread throughout 25 organ systems. The system organ classes (SOCs) focus on 
      general disorders, administration site conditions, blood and lymphatic system 
      disorders, injury, poisoning, and procedural complications. A total of 2,847 
      bevacizumab-related hemorrhage cases were reported, and 37 hemorrhagic signals 
      were identified. Hemorrhagic signals were focused on SOC levels in vascular, 
      gastrointestinal, and nervous system disorders. Colorectal, lung, and breast 
      cancers are the three most common malignancies associated with BV-induced 
      hemorrhage. CONCLUSION: The AE report from the present study confirms the 
      majority of label information for bevacizumab, while also identifying new AEs. In 
      addition, this was a large descriptive study of bevacizumab-induced hemorrhage.
FAU - Tang, Linlin
AU  - Tang L
AD  - Department of Pharmacy, Affiliated Hospital of Weifang Medical University, 
      Weifang, Shandong Province, China.
FAU - Ding, Chuanhua
AU  - Ding C
AD  - Department of Pharmacy, Affiliated Hospital of Weifang Medical University, 
      Weifang, Shandong Province, China.
FAU - Li, Hongying
AU  - Li H
AD  - Department of Pharmacy, Affiliated Hospital of Weifang Medical University, 
      Weifang, Shandong Province, China.
FAU - Yin, Guoqiang
AU  - Yin G
AD  - Department of Pharmacy, Affiliated Hospital of Weifang Medical University, 
      Weifang, Shandong Province, China.
FAU - Zhang, Haixia
AU  - Zhang H
AD  - Department of Pharmacy, Affiliated Hospital of Weifang Medical University, 
      Weifang, Shandong Province, China.
FAU - Liu, Wen Shan
AU  - Liu WS
AD  - Department of Pharmacy, Affiliated Hospital of Weifang Medical University, 
      Weifang, Shandong Province, China.
FAU - Ji, Yinghui
AU  - Ji Y
AD  - Department of Pharmacy, Affiliated Hospital of Weifang Medical University, 
      Weifang, Shandong Province, China.
FAU - Li, Hui
AU  - Li H
AD  - Department of Pharmacy, Affiliated Hospital of Weifang Medical University, 
      Weifang, Shandong Province, China.
LA  - eng
PT  - Journal Article
DEP - 20230820
PL  - England
TA  - Expert Opin Drug Saf
JT  - Expert opinion on drug safety
JID - 101163027
RN  - 2S9ZZM9Q9V (Bevacizumab)
SB  - IM
MH  - United States
MH  - Humans
MH  - Female
MH  - Bevacizumab/adverse effects
MH  - United States Food and Drug Administration
MH  - Pharmacovigilance
MH  - *Drug-Related Side Effects and Adverse Reactions/epidemiology/etiology
MH  - Hemorrhage/chemically induced/epidemiology
MH  - *Breast Neoplasms
MH  - Adverse Drug Reaction Reporting Systems
OTO - NOTNLM
OT  - Adverse event
OT  - FAERS
OT  - bevacizumab
OT  - data mining
OT  - pharmacovigilance
EDAT- 2023/08/15 12:42
MHDA- 2024/02/12 15:42
CRDT- 2023/08/15 08:32
PHST- 2024/02/12 15:42 [medline]
PHST- 2023/08/15 12:42 [pubmed]
PHST- 2023/08/15 08:32 [entrez]
AID - 10.1080/14740338.2023.2248876 [doi]
PST - ppublish
SO  - Expert Opin Drug Saf. 2024 Feb;23(2):213-220. doi: 10.1080/14740338.2023.2248876. 
      Epub 2023 Aug 20.