Evidence-based Review of Recommendations for Visual Function Testing in Patients Treated with Vigabatrin

Abstract

Recently, the United States Food and Drug Administration approved vigabatrin (Sabril^®) for the treatment of adults with refractory complex partial seizures and infants with infantile spasms. However, vigabatrin is associated with retinopathy characterized by an irreversible, bilateral, concentric peripheral visual field defect (pVFD). Given the potential risk for developing an irreversible pVFD, it is imperative that neurologists and ophthalmologists be well aware of this adverse event and take appropriate precautions to minimize its occurrence and consequences. Therefore, an expert panel was assembled to formulate comprehensive recommendations for monitoring visual function in patients of all ages treated with vigabatrin.

KEYWORDS::

• vigabatrin
• complex partial seizures
• infantile spasms
• visual field defect
• retinopathy

ACKNOWLEDGEMENTS

Financial support was received from Lundbeck Inc. (formerly Ovation Pharmaceuticals, Inc.), Deerfield, Illinois. The sponsor participated in the interpretation of vigabatrin-related data and review of the manuscript.

RCS is a consultant for Lundbeck, Inc. and Sanofi-Aventis. JWW has received financial support from National Institutes of Health, Shainberg Foundation, UCB Pharmaceuticals, Lundbeck, Inc., Questcor, Marinus, Ortho-McNeil Pharmaceuticals, King Pharmaceuticals, Cyberonics, and Eisai; and honoraria from UCB Pharmaceuticals, GlaxoSmithKline, Ortho-McNeil Pharmaceuticals, Cyberonics, Pfizer, Shire, and Valeant Pharmaceuticals. In addition, JWW is a consultant for National Institutes of Health, UCB Pharmaceuticals, GlaxoSmithkline, Lundbeck, Inc., Questcor, Marinus, Ortho-McNeil Pharmaceuticals, King Pharmaceuticals, Cyberonics, Pfizer, Eisai, Shire, Valeant Pharmaceuticals, Cydex, Inc., and Veurelis, Inc. MCS is a consultant for Abbott Laboratories, GlaxoSmithKline, Lundbeck, Inc., UCB Pharmaceuticals, Ortho-McNeil Pharmaceuticals, and Eisai; and has received honoraria from Abbott Laboratories, GlaxoSmithKline, UCB Pharmaceuticals, and Ortho-McNeil Pharmaceuticals. CAW is a consultant for Lundbeck, Inc. RHK is a consultant for Boehringer Ingelheim (Visual Field Reading Center for Drug Safety Study, University of Iowa) and Lundbeck, Inc. (analysis and interpretation of visual field data and recommendations for visual testing in patients taking vigabatrin), and receives grants from the National Institutes of Health, Department of Defense, and Department of Veterans Affairs. AA is a consultant for Pfizer and Lundbeck, Inc. RF is a consultant for Lundbeck, Inc. SMS is an employee of Lundbeck, Inc.

Declaration of interest: The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the article.