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.
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 .
Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).
Date of litterature search: 2019-10-04
Reviewed by: Mia von Euler, Carl-Olav Stiller, Diana Rydberg
Approved by: Karin Schenck-Gustafsson