PMID- 38404234
OWN - NLM
STAT- Publisher
LR  - 20240228
IS  - 1744-764X (Electronic)
IS  - 1474-0338 (Linking)
DP  - 2024 Feb 27
TI  - Adverse events associated with brolucizumab: a disproportionality analysis of the 
      FDA adverse event reporting system (FAERS).
PG  - 1-6
LID - 10.1080/14740338.2024.2322712 [doi]
AB  - BACKGROUND: The safety information of brolucizumab primarily comes from clinical 
      trials experience. This study aimed to explore the ocular and systemic adverse 
      events (AEs) associated with brolucizumab among real-world patients through data 
      mining the FDA Adverse Event Reporting System (FAERS) database. METHODS: AE 
      reports submitted to the FAERS database between October 2019 and March 2023 were 
      extracted. The reporting odds ratio was used to evaluate AE signals associated 
      with brolucizumab. RESULTS: There were 4,380,839 AE reports extracted from the 
      FAERS database, and 3,313 of which were with brolucizumab as primary suspected. A 
      total of 150 ocular AE signals were identified. Ninety-nine were known ocular AEs 
      listed in brolucizumab' label, primarily including vision-related AEs, 
      intraocular infections, and retinal disorders. Fifty-one were unexpected ocular 
      AE signals, including keratic precipitates, retinal perivascular sheathing, dry 
      eye, glaucoma, etc. Meanwhile, several serious systemic AE signals, including 
      arterial thromboembolic events and rhinorrhea, were also identified. CONCLUSIONS: 
      Several unexpected ocular and systemic AE signals associated with brolucizumab 
      were identified through data mining of the FAERS database.
FAU - Xiong, Xiaomei
AU  - Xiong X
AD  - Department of Pharmacy, Eye & ENT Hospital, Fudan University, Shanghai, China.
FAU - Zhang, Xiuwen
AU  - Zhang X
AD  - Department of Pharmacy, Eye & ENT Hospital, Fudan University, Shanghai, China.
FAU - Li, Xiaoxia
AU  - Li X
AD  - Department of Pharmacy, Eye & ENT Hospital, Fudan University, Shanghai, China.
FAU - Huang, Taomin
AU  - Huang T
AD  - Department of Pharmacy, Eye & ENT Hospital, Fudan University, Shanghai, China.
LA  - eng
PT  - Journal Article
DEP - 20240227
PL  - England
TA  - Expert Opin Drug Saf
JT  - Expert opinion on drug safety
JID - 101163027
SB  - IM
OTO - NOTNLM
OT  - Adverse event
OT  - FAERS
OT  - VEGF
OT  - brolucizumab
OT  - pharmacovigilance
EDAT- 2024/02/26 06:42
MHDA- 2024/02/26 06:42
CRDT- 2024/02/26 04:03
PHST- 2024/02/26 06:42 [pubmed]
PHST- 2024/02/26 06:42 [medline]
PHST- 2024/02/26 04:03 [entrez]
AID - 10.1080/14740338.2024.2322712 [doi]
PST - aheadofprint
SO  - Expert Opin Drug Saf. 2024 Feb 27:1-6. doi: 10.1080/14740338.2024.2322712.