Understanding and interpreting vision safety issues with vigabatrin therapy

Acta Neurologica Scandinavica

Volumn 124, Issue SUPPL. 192, 2011, Pages 57-71

  Plant, G T ^a   Sergott, R C ^b  

^a NATIONAL HOSPITAL FOR NEUROLOGY AND NEUROSURGERY   (United Kingdom)

^b THOMAS JEFFERSON UNIVERSITY   (United States)

Author keywords

Adverse events; Ocular coherence tomography; Taurine; Vigabatrin; Vision testing; Visual field defect

Indexed keywords

4 AMINOBUTYRIC ACID; CARBAMAZEPINE; PHENYTOIN; STRYCHNINE; TAURINE; VIGABATRIN; 4 AMINOBUTYRATE AMINOTRANSFERASE; ANTICONVULSIVE AGENT;

ADD ON THERAPY; ANTICONVULSANT THERAPY; ARTICLE; BIPOLAR DISORDER; BRAIN ELECTROPHYSIOLOGY; COMPLEX PARTIAL SEIZURE; DAILY LIFE ACTIVITY; DIET SUPPLEMENTATION; DISEASE ASSOCIATION; DISEASE COURSE; DISEASE SEVERITY; DIZZINESS; DROWSINESS; DRUG EXPOSURE; DRUG INDUCED HEADACHE; DRUG METABOLISM; DRUG SAFETY; DRUG TOLERABILITY; EARLY DIAGNOSIS; ELECTROOCULOGRAM; ELECTRORETINOGRAM; EPILEPSY; EYE EXAMINATION; FALSE POSITIVE RESULT; FATIGUE; FOCAL EPILEPSY; FOLLOW UP; GENETIC PREDISPOSITION; GENICULATE NUCLEUS; HUMAN; INFANTILE SPASM; KIDNEY FUNCTION; LONG TERM CARE; MONOTHERAPY; NEUROSURGERY; NONHUMAN; OBSERVATIONAL STUDY; OPTIC NERVE; OPTIC NERVE FIBER; OPTICAL COHERENCE TOMOGRAPHY; OSCILLATORY POTENTIAL; PATIENT MONITORING; PERIMETRY; PHOTORECEPTOR OUTER SEGMENT; PROSPECTIVE STUDY; RETINA CONE; RETINA GANGLION CELL; RETINA NERVE CELL; RETINAL TOXICITY; RETINOPATHY; RETROSPECTIVE STUDY; RISK ASSESSMENT; RISK FACTOR; TEMPORAL LOBECTOMY; TOXICITY; TREATMENT DURATION; TREATMENT OUTCOME; VISION TEST; VISUAL ACUITY; VISUAL FIELD DEFECT; VISUAL IMPAIRMENT; ADULT; ANIMAL; CHEMICALLY INDUCED DISORDER; COMORBIDITY; DRUG ANTAGONISM; DRUG EFFECT; EPIDEMIOLOGY; FEMALE; INFANT; MALE; METABOLISM; METHODOLOGY; RETINA; RETINA DISEASE; REVIEW; VISUAL DISORDER; VISUAL FIELD;

4-AMINOBUTYRATE TRANSAMINASE; ADULT; ANIMALS; ANTICONVULSANTS; CAUSALITY; COMORBIDITY; CONFOUNDING FACTORS (EPIDEMIOLOGY); EPILEPSIES, PARTIAL; FEMALE; HUMANS; INFANT; MALE; RETINA; RETINAL DISEASES; SPASMS, INFANTILE; TAURINE; VIGABATRIN; VISION DISORDERS; VISION TESTS; VISUAL FIELDS;

EID: 80855143872     PISSN: 00016314     EISSN: 16000404     Source Type: Journal    
DOI: 10.1111/j.1600-0404.2011.01601.x     Document Type: Article

References (100)

1. Lerner JT, Salamon N, Sankar R. Clinical profile of vigabatrin as monotherapy for treatment of infantile spasms. Neuropsychiatr Dis Treat 2010;6:731-40.
2. Waterhouse EJ, Mims KN, Gowda SN. Treatment of refractory complex partial seizures: role of vigabatrin. Neuropsychiatr Dis Treat 2009;5:505-15.
3. Faught RE. Vigabatrin therapy for refractory complex partial seizures: review of major US trials. Acta Neurol Scand 2011;124(Suppl 192):29-35.
4. Ben-Menachem E, Sander JW. Vigabatrin therapy for refractory complex partial seizures: review of major European trials. Acta Neurol Scand 2011;124(Suppl 192):16-28.
5. Carmant L. Vigabatrin therapy for infantile spasms: review of major trials in Europe, Canada, and the United States; and recommendations for dosing. Acta Neurol Scand 2011;124(Suppl. 192):36-47.
6. Willmore LJ, Abelson MB, Ben-Menachem E, Pellock JM, Shields WD. Vigabatrin: 2008 update. Epilepsia 2009;50:163-73.
7. Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J Med 2000;342:314-9.
8. Vigevano F, Cilio MR. Vigabatrin versus ACTH as first-line treatment for infantile spasms: a randomized, prospective study. Epilepsia 1997;38:1270-4.
9. Elterman RD, Shields WD, Bittman RM, Torri SA, Sagar SM, Collins SD. Vigabatrin for the treatment of infantile spasms: final report of a randomized trial. J Child Neurol 2010;25:1340-7.
10. Appleton RE, Peters AC, Mumford JP, Shaw DE. Randomised, placebo-controlled study of vigabatrin as first-line treatment of infantile spasms. Epilepsia 1999;40:1627-33.
11. Granström ML, Gaily E, Liukkonen E. Treatment of infantile spasms: results of a population-based study with vigabatrin as the first drug for spasms. Epilepsia 1999;40:950-7.
12. Lux AL, Edwards SW, Hancock E, et al. The United Kingdom Infantile Spasms Study (UKISS) comparing hormone treatment with vigabatrin on developmental and epilepsy outcomes to age 14months: a multicentre randomised trial. Lancet Neurol 2005;4:712-7.
13. Sergott RC, Wheless JW, Smith MC et al. Evidence-based review of recommendations for visual function testing in patients treated with vigabatrin. Neuro-ophthalmology 2010;34:20-35.
14. Eke T, Talbot JF, Lawden MC. Severe persistent visual field constriction associated with vigabatrin. BMJ 1997;314:180-1.
15. Gonzalez P, Sills GJ, Parks S et al. Binasal visual field defects are not specific to vigabatrin. Epilepsy Behav 2009;16:521-6.
16. Malmgren K, Ben-Menachem E, Frisén L. Vigabatrin visual toxicity: evolution and dose dependence. Epilepsia 2001;42:609-15.
17. Chiron C, Dulac O. Epilepsy: vigabatrin treatment and visual field loss. Nat Rev Neurol 2011;7:189-90.
18. Kälviäinen R, Nousiainen I. Visual field defects with vigabatrin: epidemiology and therapeutic implications. CNS Drugs 2001;15:217-30.
19. Wild JM, Ahn HS, Baulac M et al. Vigabatrin and epilepsy: lessons learned. Epilepsia 2007;48:1318-27.
20. Krauss GL. Evaluating risks for vigabatrin treatment. Epilepsy Curr 2009;9:125-9.
21. Lawden M. Vigabatrin-associated visual field constriction: a review. Optometry Pract 2006;7:1-16.
22. Wilson EA, Brodie MJ. Severe persistent visual field constriction associated with vigabatrin. Chronic refractory epilepsy may have role in causing these unusual lesions. BMJ 1997;314:1693.
23. Baulac M, Nordmann JP, Lanoe Y. Severe visual-field constriction and side-effects of GABA-mimetic antiepileptic agents. Lancet 1998;352:546.
24. Lawden MC, Eke T, Degg C, Harding GF, Wild JM. Visual field defects associated with vigabatrin therapy. J Neurol Neurosurg Psychiatry 1999;67:716-22.
25. Nicolson A, Leach JP, Chadwick DW, Smith DF. The legacy of vigabatrin in a regional epilepsy clinic. J Neurol Neurosurg Psychiatry 2002;73:327-9.
26. Wild JM, Martinez C, Reinshagen G, Harding GF. Characteristics of a unique visual field defect attributed to vigabatrin. Epilepsia 1999;40:1784-94.
27. Vanhatalo S, Alen R, Riikonen R et al. Reversed visual field constrictions in children after vigabatrin withdrawal - True retinal recovery or improved test performance only? Seizure 2001;10:508-11.
28. Hardus P, Verduin WM, Postma G, Stilma JS, Berendschot TT, Van Veelen CW. Concentric contraction of the visual field in patients with temporal lobe epilepsy and its association with the use of vigabatrin medication. Epilepsia 2000;41:581-7.
29. Besch D, Kurtenbach A, Apfelstedt-Sylla E et al. Visual field constriction and electrophysiological changes associated with vigabatrin. Doc Ophthalmol 2002;104:151-70.
30. Newman WD, Tocher K, Acheson JF. Vigabatrin associated visual field loss: a clinical audit to study prevalence, drug history and effects of drug withdrawal. Eye (Lond) 2002;16:567-71.
31. Kälviäinen R, Nousiainen I, Mantyjarvi M et al. Vigabatrin, a GABAergic antiepileptic drug, causes concentric visual field defects. Neurology 1999;53:922-6.
32. Stefan H, Bernati K, Knorr HLJ. Visual field constriction and anti-epileptic drug treatment. Neurol Psychiatr Brain Res 2000;7:185-90.
33. Schmitz B, Schmidt T, Jokiel B, Pfeiffer S, Tiel-Wilck K, Rüther K. Visual field constriction in epilepsy patients treated with vigabatrin and other antiepileptic drugs: a prospective study. J Neurol 2002;249:469-75.
34. Miller NR, Johnson MA, Paul SR et al. Visual dysfunction in patients receiving vigabatrin: clinical and electrophysiologic findings. Neurology 1999;53:2082-7.
35. Wheless JW, Ramsay RE, Collins SD. Vigabatrin. Neurotherapeutics 2007;4:163-72.
36. Wild JM, Chiron C, Ahn H et al. Visual field loss in patients with refractory partial epilepsy treated with vigabatrin: final results from an open-label, observational, multicentre study. CNS Drugs 2009;23:965-82.
37. Gonzalez PA, McCall A, McQuistan AM et al. Assessing Retinal Toxicity of Vigabatrin and Other GABA-ergic Drugs in Patients with Epilepsy. Invest Ophthalmol Vis Sci 2006;47:E-Abstract 1658.
38. Maguire MJ, Hemming K, Wild JM, Hutton JL, Marson AG. Prevalence of visual field loss following exposure to vigabatrin therapy: a systematic review. Epilepsia 2010;51:2423-31.
39. Buncic JR, Westall CA, Panton CM, Munn JR, MacKeen LD, Logan WJ. Characteristic retinal atrophy with secondary "inverse" optic atrophy identifies vigabatrin toxicity in children. Ophthalmology 2004;111:1935-42.
40. Morong S, Westall CA, Nobile R et al. Longitudinal changes in photopic OPs occurring with vigabatrin treatment. Doc Ophthalmol 2003;107:289-97.
41. Westall CA, Logan WJ, Smith K, Buncic JR, Panton CM, Abdolell M. The Hospital for Sick Children, Toronto, longitudinal ERG study of children on vigabatrin. Doc Ophthalmol 2002;104:133-49.
42. Westall CA, Nobile R, Morong S, Buncic JR, Logan WJ, Panton CM. Changes in the electroretinogram resulting from discontinuation of vigabatrin in children. Doc Ophthalmol 2003;107:299-309.
43. Sergott RC, Bittman RM, Christen EM, Sagar SM. Vigabatrin-induced peripheral visual field defects in patients with refractory partial epilepsy. Epilepsy Res 2010;92:170-6.
44. Manuchehri K, Goodman S, Siviter L, Nightingale S. A controlled study of vigabatrin and visual abnormalities. Br J Ophthalmol 2000;84:499-505.
45. Arndt CF, Salle M, Derambure PH et al. The effect on vision of associated treatments in patients taking vigabatrin: carbamazepine versus valproate. Epilepsia 2002;43:812-7.
46. Conway M, Cubbidge RP, Hosking SL. Visual field severity indices demonstrate dose- dependent visual loss from vigabatrin therapy. Epilepsia 2008;49:108-16.
47. ® (vigabatrin). Poster presented at the 64th annual meeting of the American Epilepsy Society; December 3-7, 2010; San Antonio, TX.
48. Kinirons P, Cavalleri GL, O'Rourke D et al. Vigabatrin retinopathy in an Irish cohort: lack of correlation with dose. Epilepsia 2006;47:311-7.
49. Best JL, Acheson JF. The natural history of vigabatrin associated visual field defects in patients electing to continue their medication. Eye 2004;19:41-4.
50. Paul SR, Krauss GL, Miller NR, Medura MT, Miller TA, Johnson MA. Visual function is stable in patients who continue long-term vigabatrin therapy: implications for clinical decision making. Epilepsia 2001;42:525-30.
51. Clayton LM, Duncan JS, Sisodiya SM, Acheson JF. Delayed, rapid visual field loss in a patient after ten years of vigabatrin therapy. Eye (Lond) 2010;24:185-6.
52. Krakow K, Polizzi G, Riordan-Eva P et al. Recovery of visual field constriction following discontinuation of vigabatrin. Seizure 2000;9:287-90.
53. Acheson JF. Vigabatrin associated visual field constriction. J Neurol Neurosurg Psychiatry 1999;67:707-8.
54. Harding GF. Severe persistent visual field constriction associated with vigabatrin. Four possible explanations exist. BMJ 1997;314:1694.
55. French JA, Gazzola DM. New generation antiepileptic drugs: what do they offer in terms of improved tolerability and safety? Ther Adv Drug Saf [published online ahead of print June 22, 2011], doi:.
56. Bruni J, Guberman A, Vachon L, Desforges C. Vigabatrin as add-on therapy for adult complex partial seizures: a double-blind, placebo-controlled multicentre study. The Canadian Vigabatrin Study Group. Seizure 2000;9:224-32.
57. Zamponi N, Cardinali C. Open comparative long-term study of vigabatrin vs. carbamazepine in newly diagnosed partial seizures in children. Arch Neurol 1999;56:605-7.
58. Walker SD, Kälviäinen R. Non-vision adverse events with vigabatrin therapy. Acta Neurol Scand 2011;124(Suppl. 192):72-82.
59. Harding GF, Wild JM, Robertson KA, Rietbrock S, Martinez C. Separating the retinal electrophysiologic effects of vigabatrin: treatment versus field loss. Neurology 2000;55:347-52.
60. Lawthom C, Smith PE, Wild JM. Nasal retinal nerve fiber layer attenuation: a biomarker for vigabatrin toxicity. Ophthalmology 2009;116:565-71.
61. Rintahaka P, Granstrom ML, Lappi M et al. Visual field defects in vigabatrin-treated children with epilepsy. Epilepsia 2000;41(Suppl 7):196-7.
62. Sergott RC, Westall CA. Primer on visual field testing methods and related algorithms for patients treated with vigabatrin. Acta Neurol Scand 2011;124(Suppl. 192):48-56.
63. Clayton LM, Dévilé M, Punte T et al. Retinal nerve fiber layer thickness in vigabatrin-exposed patients. Ann Neurol 2011;69:845-54.
64. Cheng H, Laron M, Schiffman JS, Tang RA, Frishman LJ. The relationship between visual field and retinal nerve fiber layer measurements in patients with multiple sclerosis. Invest Ophthalmol Vis Sci 2007;48:5798-805.
65. Oishi A, Otani A, Sasahara M et al. Retinal nerve fiber layer thickness in patients with retinitis pigmentosa. Eye (Lond) 2009;23:561-6.
66. Pasadhika S, Fishman GA, Allikmets R, Stone EM. Peripapillary retinal nerve fiber layer thinning in patients with autosomal recessive cone-rod dystrophy. Am J Ophthalmol 2009;148:260-5.
67. ® (vigabatrin): an open-label, Phase IV study. Poster 1.294. Presented at the 64th annual meeting of the American Epilepsy Society; December 3-7, 2010; San Antonio, TX.
68. Arndt CF, Derambure P, Defoort-Dhellemmes S, Hache JC. Outer retinal dysfunction in patients treated with vigabatrin. Neurology 1999;52:1201-5.
69. Daneshvar H, Racette L, Coupland SG, Kertes PJ, Guberman A, Zackon D. Symptomatic and asymptomatic visual loss in patients taking vigabatrin. Ophthalmology 1999;106:1792-8.
70. Midelfart A, Midelfart E, Brodtkorb E. Visual field defects in patients taking vigabatrin. Acta Ophthalmol Scand 2000;78:580-4.
71. Mauri-Llerda JA, Iñiguez C, Tejero-Juste C et al. Visual field changes secondary to vigabatrin treatment [in Spanish]. Rev Neurol 2000;31:1104-8.
72. Toggweiler S, Wieser HG. Concentric visual field restriction under vigabatrin therapy: extent depends on the duration of drug intake. Seizure 2001;10:420-3.
73. Nousiainen I, Mäntyjärvi M, Kälviäinen R. No reversion in vigabatrin-associated visual field defects. Neurology 2001;57:1916-7.
74. Jensen H, Sjö O, Uldall P, Gram L. Vigabatrin and retinal changes. Doc Ophthalmol 2002;104:171-80.
75. Van Der Torren K, Graniewski-Wijnands HS, Polak BC. Visual field and electrophysiological abnormalities due to vigabatrin. Doc Ophthalmol 2002;104:181-8.
76. McCoy B, Wright T, Weiss S, Go C, Westall CA. Electroretinogram changes in a pediatric population with epilepsy: is vigabatrin acting alone? J Child Neurol 2011;26:729-33.
77. Jung P, Doussard-Lefaucheux S. Visual field defect in a patient given sodium valproate then carbamazepine: possible effect of aminotransferase inhibition [in French]. Rev Neurol (Paris) 2002;158:477-9.
78. Tilz C, Wang-Tilz Y, Junemann A, Stefan H, Michelson G. Visual field defect during therapy with valproic-acid. Eur J Neurol 2007;14:929-32.
79. Lorenz R, Kuck H. Visual disorders caused by diphenylhydantoin: clinical and electro-ophthalmologic findings [in German]. Klin Monbl Augenheilkd 1988;192:244-7.
80. Kaufman KR, Lepore FE, Keyser BJ. Visual fields and tiagabine: a quandary. Seizure 2001;10:525-9.
81. Jeelani NU, Jindahra P, Tamber MS et al. Hemispherical asymmetry in the Meyer's Loop: a prospective study of visual-field deficits in 105 cases undergoing anterior temporal lobe resection for epilepsy. J Neurol Neurosurg Psychiatry 2010;81:985-91.
82. Ben-Menachem E. Mechanism of action of vigabatrin: correcting misperceptions. Acta Neurol Scand 2011;124(Suppl. 192):5-15.
83. Sills GJ, Patsalos PN, Butler E, Forrest G, Ratnaraj N, Brodie MJ. Visual field constriction: accumulation of vigabatrin but not tiagabine in the retina. Neurology 2001;57:196-200.
84. Sills GJ, Butler E, Forrest G, Ratnaraj N, Patsalos PN, Brodie MJ. Vigabatrin, but not gabapentin or topiramate, produces concentration-related effects on enzymes and intermediates of the GABA shunt in rat brain and retina. Epilepsia 2003;44:886-92.
85. Butler WH, Ford GP, Newberne JW. A study of the effects of vigabatrin on the central nervous system and retina of Sprague Dawley and Lister-Hooded rats. Toxicol Pathol 1987;15:143-8.
86. Nousiainen I, Mäntyjärvi M, Kälviäinen R. Visual function in patients treated with the GABAergic anticonvulsant drug tiagabine. Clin Drug Invest 2000;20:393-400.
87. Wild JM, Robson CR, Jones AL, Cunliffe IA, Smith PE. Detecting vigabatrin toxicity by imaging of the retinal nerve fiber layer. Invest Ophthalmol Vis Sci 2006;47:917-24.
88. Frisen L, Malmgren K. Characterization of vigabatrin-associated optic atrophy. Acta Ophthalmol Scand 2003;81:466-73.
89. Harding GF, Wild JM, Robertson KA et al. Electro-oculography, electroretinography, visual evoked potentials, and multifocal electroretinography in patients with vigabatrin-attributed visual field constriction. Epilepsia 2000;41:1420-31.
90. Ravindran J, Blumbergs P, Crompton J, Pietris G, Waddy H. Visual field loss associated with vigabatrin: pathological correlations. J Neurol Neurosurg Psychiatry 2001;70:787-9.
91. Schmidt SY, Berson EL, Hayes KC. Retinal degeneration in cats fed casein. I. Taurine deficiency. Invest Ophthalmol 1975;15:47-52.
92. Heller-Stilb B, Van Roeyen C, Rascher K et al. Disruption of the taurine transporter gene (taut) leads to retinal degeneration in mice. FASEB J 2002;16:231-3.
93. Alm A, Tornquist P. Amino acid transport through the blood-retinal and the blood-brain barrier. Graefes Arch Clin Exp Ophthalmol 1985;222:177-8.
94. Tomi M, Tajima A, Tachikawa M, Hosoya K. Function of taurine transporter (Slc6a6/TauT) as a GABA transporting protein and its relevance to GABA transport in rat retinal capillary endothelial cells. Biochim Biophys Acta 2008;1778:2138-42.
95. Geggel HS, Ament ME, Heckenlively JR, Martin DA, Kopple JD. Nutritional requirement for taurine in patients receiving long-term parenteral nutrition. N Engl J Med 1985;312:142-6.
96. Young TL, Cepko CL. A role for ligand-gated ion channels in rod photoreceptor development. Neuron 2004;41:867-79.
97. Jammoul F, Wang Q, Nabbout R et al. Taurine deficiency is a cause of vigabatrin-induced retinal phototoxicity. Ann Neurol 2009;65:98-107.
98. Jammoul F, Degardin J, Pain D et al. Taurine deficiency damages photoreceptors and retinal ganglion cells in vigabatrin-treated neonatal rats. Mol Cell Neurosci 2010;43:414-21.
99. Lee NY, Kang YS. The brain-to-blood efflux transport of taurine and changes in the blood-brain barrier transport system by tumor necrosis factor-alpha. Brain Res 2004;1023:141-7.
100. Pellock JM, Faught E, Sergott RC et al. Registry initiated to characterize vision loss associated with vigabatrin therapy. Epilepsy Behav 2011; DOI: doi.org/10.1016/j.yebeh.2011.08.034.