PMID- 37665052
OWN - NLM
STAT- MEDLINE
DCOM- 20240308
LR  - 20240308
IS  - 1744-764X (Electronic)
IS  - 1474-0338 (Linking)
VI  - 23
IP  - 3
DP  - 2024 Mar
TI  - A real-world disproportionality analysis of anti-VEGF drugs from the FDA Adverse 
      Event Reporting System.
PG  - 363-371
LID - 10.1080/14740338.2023.2250717 [doi]
AB  - BACKGROUND: The association between anti-vascular endothelial growth factor 
      (VEGF) drugs and ocular adverse events (AEs) has been reported, but large 
      real-world studies of their association with systemic AEs are still lacking. 
      METHODS: A disproportionality analysis of reports from the FDA Adverse Event 
      Reporting System from January 2004 to September 2021 was conducted to detect the 
      significant ADR signals with anti-VEGF drugs (including aflibercept, bevacizumab, 
      brolucizumab, pegaptanib, and ranibizumab). RESULTS: A total of 2980 reported 
      cases with 7125 drug-AEs were included. Five drugs were all associated with eye 
      disorders, and pegaptanib and ranibizumab were also associated with cardiac 
      disorders. For ranibizumab, pegaptanib, bevacizumab and aflibercept, the 
      proportions of cardiac AEs were 8.57%, 5.62%, 3.43% and 3.20%, respectively, and 
      the proportions of central nervous AEs were 8.81%, 7.41, 5.86% and 5.68%, 
      respectively. In multiple comparisons, ranibizumab was significantly higher than 
      bevacizumab and aflibercept in the proportion of cardiac AEs (P < 0.001), and 
      ranibizumab was significantly higher than aflibercept in central nervous AEs 
      (P < 0.001). CONCLUSIONS: Our findings support the associations between anti-VEGF 
      drugs and ocular AEs, cardiac AEs, and central nervous AEs. After intravitreal 
      injection, attention should not only be paid to ocular symptoms, but also to 
      systemic symptoms.
FAU - Zhou, Ruishan
AU  - Zhou R
AUID- ORCID: 0000-0001-5804-8523
AD  - School of Public Health, Guangdong Pharmaceutical University, Guangzhou, China.
FAU - Lu, Peiwen
AU  - Lu P
AD  - School of Public Health, Guangdong Pharmaceutical University, Guangzhou, China.
FAU - He, Mingxiu
AU  - He M
AD  - School of Public Health, Guangdong Pharmaceutical University, Guangzhou, China.
FAU - Chen, Junheng
AU  - Chen J
AD  - School of Public Health, Guangdong Pharmaceutical University, Guangzhou, China.
FAU - Shi, Yiyang
AU  - Shi Y
AD  - School of Public Health, Guangdong Pharmaceutical University, Guangzhou, China.
FAU - Han, Fangfang
AU  - Han F
AD  - School of Medical Information and Engineering, Guangdong Pharmaceutical 
      University, Guangzhou, China.
AD  - NMPA Key Laboratory for Technology Research and Evaluation of Pharmacovigilance, 
      Guangzhou, China.
FAU - Cai, Yongming
AU  - Cai Y
AD  - School of Medical Information and Engineering, Guangdong Pharmaceutical 
      University, Guangzhou, China.
AD  - NMPA Key Laboratory for Technology Research and Evaluation of Pharmacovigilance, 
      Guangzhou, China.
AD  - Guangdong Provincial Traditional Chinese Medicine Precision Medicine Big Data 
      Engineering Technology Research Center, Guangzhou, China.
LA  - eng
PT  - Journal Article
DEP - 20230904
PL  - England
TA  - Expert Opin Drug Saf
JT  - Expert opinion on drug safety
JID - 101163027
RN  - ZL1R02VT79 (Ranibizumab)
RN  - 2S9ZZM9Q9V (Bevacizumab)
RN  - 0 (Angiogenesis Inhibitors)
RN  - 0 (Vascular Endothelial Growth Factor A)
RN  - EC 2.7.10.1 (Receptors, Vascular Endothelial Growth Factor)
RN  - 0 (Recombinant Fusion Proteins)
SB  - IM
MH  - Humans
MH  - *Ranibizumab/adverse effects
MH  - Bevacizumab/adverse effects
MH  - *Angiogenesis Inhibitors/adverse effects
MH  - Vascular Endothelial Growth Factor A
MH  - Receptors, Vascular Endothelial Growth Factor
MH  - Intravitreal Injections
MH  - Recombinant Fusion Proteins/adverse effects
OTO - NOTNLM
OT  - Anti-VEGF drugs
OT  - FAERS database
OT  - adverse events
OT  - disproportionality analysis
OT  - drug safety
EDAT- 2023/09/04 12:42
MHDA- 2024/03/08 06:43
CRDT- 2023/09/04 06:53
PHST- 2024/03/08 06:43 [medline]
PHST- 2023/09/04 12:42 [pubmed]
PHST- 2023/09/04 06:53 [entrez]
AID - 10.1080/14740338.2023.2250717 [doi]
PST - ppublish
SO  - Expert Opin Drug Saf. 2024 Mar;23(3):363-371. doi: 10.1080/14740338.2023.2250717. 
      Epub 2023 Sep 4.