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Vigabatrin

Classification: A

Drug products: Sabril Beutel, Sabrilex®

ATC code: N03AG04

Substances: vigabatrin

Summary

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.

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).

Updated: 2019-02-26

Date of litterature search: 2013-03-08

References

  1. Sabril (vigabatrin). DailyMed [www]. US National Library of Medicine. [updated 2012-12-01, cited 2013-03-08]. länk
  2. Sabrilex (vigabatrin). Summary of Product Characteristics. Medical Products Agency Sweden; 2014. länk
  3. Morrell MJ. The new antiepileptic drugs and women: efficacy, reproductive health, pregnancy, and fetal outcome. Epilepsia. 1996;37 Suppl 6:S34-44. PubMed
  4. Kälviäinen R, Nousiainen I. Visual field defects with vigabatrin: epidemiology and therapeutic implications. CNS Drugs. 2001;15:217-30. PubMed
  5. EMA. Opinion of the Committee for Proprietary Medicinal Products pursuant to article 12 of council directive 75/319/eec as amended, for Vigabatrin. 1999.
  6. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2015 [cited 2016-04-29] länk

Authors: Linnéa Karlsson Lind, Desirée Loikas

Reviewed by: Expertrådet för neurologiska sjukdomar, Ellen Vinge

Approved by: Mia von Euler