Drug products: Sabril Beutel, Sabrilex®
ATC code: N03AG04
Studies have shown that vigabatrin can cause disturbed visual fields. The risk seems to be higher in men.
Pharmacokinetics and dosing
No differences in vigabatrin pharmacokinetics have been seen between men and women [1-4] and no sex differentiation in dosing has been recommended [2, 3].
The anticonvulsive effect of vigabatrin appears to be the same in women as in men. Two multicenter, double-blind, placebo-controlled, parallel-group clinical studies evaluating the effectiveness of vigabatrin found no sex difference [2, 5].
Pooled data from prevalence studies have found that as many as 30% of patients receiving vigabatrin develop visual field defects. Two separate studies have observed that male sex is associated with an increased risk of visual field defects [3, 6-8]. In the Marketing Authorization Holders cohort, a positive association was found for male sex and vigabatrin attributed visual field loss (cumulative incidence ratio 1.9). Limited published reports suggest that the visual field defects are irreversible even after discontinuation of vigabatrin treatment .
Reproductive health issues
Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).
Date of litterature search: 2019-10-04
- Food and Drug Administration (FDA). Clinical Pharmacology and Biopharmaceutics Review - SABRIL (vigabatrin). Drugs@FDA [www]. [updated 2009-11-12, cited 2019-10-04]. länk
- Sabril (vigabatrin). DailyMed [www]. US National Library of Medicine. [updated 2019-08-14, cited 2019-10-04]. länk
- Sabrilex (vigabatrin). Summary of Product Characteristics. Swedish Medical Products Agency [updated 2018-06-07, cited 2019-10-04]. länk
- Nielsen JC, Kowalski KG, Karim A, Patel M, Wesche DL, Tolbert D. Population pharmacokinetics analysis of vigabatrin in adults and children with epilepsy and children with infantile spasms. Clin Pharmacokinet. 2014;53(11):1019-31. PubMed
- Morrell MJ. The new antiepileptic drugs and women: efficacy, reproductive health, pregnancy, and fetal outcome. Epilepsia. 1996;37 Suppl 6:S34-44. PubMed
- Kälviäinen R, Nousiainen I. Visual field defects with vigabatrin: epidemiology and therapeutic implications. CNS Drugs. 2001;15:217-30. PubMed
- Wild JM, Ahn HS, Baulac M, Bursztyn J, Chiron C, Gandolfo E et al. Vigabatrin and epilepsy: lessons learned. Epilepsia. 2007;48(7):1318-27. PubMed
- Westall CA, Wright T, Cortese F, Kumarappah A, Snead OC, Buncic JR. Vigabatrin retinal toxicity in children with infantile spasms: An observational cohort study. Neurology. 2014;83(24):2262-8. PubMed
- EMA. Opinion of the Committee for Proprietary Medicinal Products pursuant to article 12 of council directive 75/319/eec as amended, for Vigabatrin. 1999.
- Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2019 [cited 2020-03-10.] länk
Reviewed by: Mia von Euler, Carl-Olav Stiller, Diana Rydberg
Approved by: Karin Schenck-Gustafsson