Vigabatrin

Additional information

Pharmacokinetics and dosing

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].

Effects

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].

Adverse effects

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 [5].

Reproductive health issues

Regarding teratogenic aspects, please consult the Drugs and Birth Defects Database (in Swedish, Janusmed fosterpåverkan).