Kommersiellt obunden läkemedelsinformation riktad till läkare och sjukvårdspersonal

Vigabatrin

Klassificering: A

Preparat: Sabril Beutel, Sabrilex, Sabrilex®

ATC kod: N03AG04

Substanser: vigabatrin

Sammanfattning

Studier har visat att vigabatrin kan orsaka synfältsdefekter. Risken kan vara större för män än för kvinnor.
 
Kunskapsunderlaget avseende skillnader mellan kvinnor och män är begränsat och motiverar inte olika dosering eller behandling.

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).

Försäljning på recept

Nästan lika många män och kvinnor hämtade ut läkemedel innehållande vigabatrin (ATC-kod N03AG04) på recept i Sverige år 2015, totalt 157 män och 140 kvinnor [6].

Uppdaterat: 2019-02-26

Litteratursökningsdatum: 2013-03-08

Referenser

  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

Författare: Linnéa Karlsson Lind, Desirée Loikas

Faktagranskat av: Expertrådet för neurologiska sjukdomar, Ellen Vinge

Godkänt av: Mia von Euler