June 2020
Volume 61, Issue 7
ARVO Annual Meeting Abstract  |   June 2020
Visual and Ophthalmic Adverse Events Associated with Vigabatrin Therapy
Author Affiliations & Notes
  • Zachary Bergman
    Ophthalmology, University of Maryland Medical Center, Baltimore, Maryland, United States
  • Albert Li
    Ophthalmology, University of Maryland Medical Center, Baltimore, Maryland, United States
  • Footnotes
    Commercial Relationships   Zachary Bergman, None; Albert Li, None
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science June 2020, Vol.61, 2972. doi:
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      Zachary Bergman, Albert Li; Visual and Ophthalmic Adverse Events Associated with Vigabatrin Therapy. Invest. Ophthalmol. Vis. Sci. 2020;61(7):2972.

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      © ARVO (1962-2015); The Authors (2016-present)

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Purpose : Vigabatrin is an antiepileptic drug that has been used in the treatment of infantile spasms and other partial seizure disorders unresponsive to other antiepileptics. Currently, Vigabatrin carries a black box warning of permanent concentric visual field constriction which may affect thirty percent or more of patients. Additionally, Vigabatrin has been shown in scientific studies to cause retinal toxicity manifesting as abnormal electroretinograms with a predilection for the cone system. The purpose of this research is to identify adverse visual and ophthalmic effects of Vigabatrin therapy to inform clinical practice and monitoring.

Methods : The Food and Drug Administration Adverse Event Report System (FAERS) is a collection of public and deidentified for providers to report adverse events experienced by patients to various medical therapies. Data from this system was analyzed with regards to ophthalmic and visual side effects. The outcomes were grouped by category and subsequently evaluated for gender predilection, age, and date reported.

Results : In all, there were 793 adverse outcomes reported to FAERS involving the eye and visual system. A total of 251 cases of visual impairment, including visual field abnormalities, were reported to FAERS; this was the most commonly reported category of adverse events. However, the majority of cases reported involved other components of the ophthalmic and visual systems. The most common other categories included retinal toxicity (162 cases), eye movement disorders (98 cases), blindness (69 cases), and optic nerve abnormalities (63 cases).

Conclusions : While Vigabatrin carries a black box warning for visual impairment and tunnel vision, there are other significant ophthalmic and visual adverse events reported to the FAERS database. These findings should influence the management and monitoring practices of both primary providers and Ophthalmologists with patients on long term Vigabatrin therapy.

This is a 2020 ARVO Annual Meeting abstract.


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