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.
The present evidence concerning differences between men and women is limited and do not motivate differentiation in dosing or treatment.
No differences in vigabatrin pharmacokinetics have been seen between men and women and no sex differentiation in dosing has been recommended by the manufacturer [1, 2].
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 [1, 3].
Pooled data from prevalence studies have found that as many as 30% of patients receiving vigabatrin have visual field defects. Two separate studies have observed that male sex is associated with an increased risk of visual field defects [2, 4]. In the Marketing Authorization Holders cohort, a positive association was found for male sex and vigabatrin attributed visual field loss with a cumulative incidence ratio of 1.9. Limited published reports suggest that the visual field defects are irreversible even after discontinuation of vigabatrin treatment .
Regarding teratogenic aspects, please consult the Drugs and Birth Defects Database (in Swedish, Janusmed fosterpåverkan).
Date of litterature search: 2013-03-08
Reviewed by: Expertrådet för neurologiska sjukdomar, Ellen Vinge
Approved by: Mia von Euler