PMID- 37608598
OWN - NLM
STAT- MEDLINE
DCOM- 20240308
LR  - 20240308
IS  - 1744-764X (Electronic)
IS  - 1474-0338 (Linking)
VI  - 23
IP  - 3
DP  - 2024 Mar
TI  - Ocular adverse events of cenegermin used in neurotrophic keratopathy: an analysis 
      of the FDA adverse event reporting system database.
PG  - 385-391
LID - 10.1080/14740338.2023.2251389 [doi]
AB  - BACKGROUND: Cenegermin, a recombinant human nerve growth factor, is an orphan 
      drug approved for neurotrophic keratitis. The safety information on the label is 
      incomplete, and the adverse reactions noted are mostly mild and tolerable. 
      However, the occurrence of painful epithelial plagues and irreversible corneal 
      deposits after cenegermin usage have been reported. Real-world data on long-term 
      ocular safety are lacking. We aimed to assess the cenegermin-associated eye 
      safety profile in the FDA pharmacovigilance database. METHODS: The signals of 
      cenegermin-related ocular adverse events (AEs) from 2018 to 2022 were quantified 
      using the reporting odds ratio (ROR) and information component (IC). The grading 
      system was used to prioritize the signals. RESULTS: We identified 3288 cases of 
      cenegermin-related ocular AEs and 56 positive ocular-related signals. Fifty 
      unexpected signals of ocular AE were identified. Eye ulcer was classified as a 
      designated medical event. Twenty AEs, including corneal perforation, eye 
      infection, corneal deposits, and eye inflammation, were recognized as important 
      medical event. The median onset time for ocular AEs was 6 days (interquartile 
      range [IQR]: 1-29 days). CONCLUSION: This study revealed new cenegermin-related 
      ocular AE signals. Clinical practice requires close monitoring to early identify 
      and manage adverse reactions that may cause occurrence of serious irreversible 
      consequences.
FAU - Li, Yunfei
AU  - Li Y
AD  - Department of Ophthalmology, West China Hospital of Sichuan University, Chengdu, 
      Sichuan Province, China.
FAU - Yang, Haiyun
AU  - Yang H
AD  - School of Pharmacy, Lanzhou University, Lanzhou, Gansu, P.R. China.
FAU - Gao, Yuan
AU  - Gao Y
AD  - School of Pharmacy, Lanzhou University, Lanzhou, Gansu, P.R. China.
FAU - He, Weimin
AU  - He W
AD  - Department of Ophthalmology, West China Hospital of Sichuan University, Chengdu, 
      Sichuan Province, China.
LA  - eng
PT  - Journal Article
DEP - 20230828
PL  - England
TA  - Expert Opin Drug Saf
JT  - Expert opinion on drug safety
JID - 101163027
RN  - B6E7K36KT8 (cenegermin)
RN  - 9061-61-4 (Nerve Growth Factor)
RN  - 0 (Recombinant Proteins)
SB  - IM
MH  - Humans
MH  - *Keratitis/chemically induced/epidemiology
MH  - Nerve Growth Factor/adverse effects
MH  - Recombinant Proteins
MH  - Pharmacovigilance
OTO - NOTNLM
OT  - Cenegermin
OT  - FDA adverse event reporting system
OT  - drug safety
OT  - neurotrophic keratitis
OT  - pharmacovigilance
EDAT- 2023/08/23 06:42
MHDA- 2024/03/08 06:43
CRDT- 2023/08/23 02:09
PHST- 2024/03/08 06:43 [medline]
PHST- 2023/08/23 06:42 [pubmed]
PHST- 2023/08/23 02:09 [entrez]
AID - 10.1080/14740338.2023.2251389 [doi]
PST - ppublish
SO  - Expert Opin Drug Saf. 2024 Mar;23(3):385-391. doi: 10.1080/14740338.2023.2251389. 
      Epub 2023 Aug 28.