Ocular adverse events of cenegermin used in neurotrophic keratopathy: an analysis of the FDA adverse event reporting system database
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...
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Published in | Expert opinion on drug safety Vol. 23; no. 3; p. 385 |
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Main Authors | , , , |
Format | Journal Article |
Language | English |
Published |
England
01.03.2024
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Abstract | 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.
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.
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).
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. |
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AbstractList | 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.
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.
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).
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. |
Author | Gao, Yuan He, Weimin Li, Yunfei Yang, Haiyun |
Author_xml | – sequence: 1 givenname: Yunfei surname: Li fullname: Li, Yunfei organization: Department of Ophthalmology, West China Hospital of Sichuan University, Chengdu, Sichuan Province, China – sequence: 2 givenname: Haiyun surname: Yang fullname: Yang, Haiyun organization: School of Pharmacy, Lanzhou University, Lanzhou, Gansu, P.R. China – sequence: 3 givenname: Yuan surname: Gao fullname: Gao, Yuan organization: School of Pharmacy, Lanzhou University, Lanzhou, Gansu, P.R. China – sequence: 4 givenname: Weimin surname: He fullname: He, Weimin organization: Department of Ophthalmology, West China Hospital of Sichuan University, Chengdu, Sichuan Province, China |
BackLink | https://www.ncbi.nlm.nih.gov/pubmed/37608598$$D View this record in MEDLINE/PubMed |
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Snippet | Cenegermin, a recombinant human nerve growth factor, is an orphan drug approved for neurotrophic keratitis. The safety information on the label is incomplete,... |
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Title | Ocular adverse events of cenegermin used in neurotrophic keratopathy: an analysis of the FDA adverse event reporting system database |
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