Kommersiellt obunden läkemedelsinformation riktad till läkare och sjukvårdspersonal

Vigabatrin

Klassificering: C

Preparat: Sabril Beutel, Sabrilex®

ATC kod: N03AG04

Substanser: vigabatrin

Sammanfattning

Studier har visat att vigabatrin kan orsaka synfältsdefekter. Risken verkar vara större för män än för kvinnor.

Additional information

Pharmacokinetics and dosing

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].

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 [2, 5].

Adverse effects

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 [9].

Reproductive health issues

Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (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 2019, totalt 170 män och 127 kvinnor [10].

Uppdaterat: 2020-09-08

Litteratursökningsdatum: 2019-10-04

Referenser

  1. Food and Drug Administration (FDA). Clinical Pharmacology and Biopharmaceutics Review - SABRIL (vigabatrin). Drugs@FDA [www]. [updated 2009-11-12, cited 2019-10-04]. länk
  2. Sabril (vigabatrin). DailyMed [www]. US National Library of Medicine. [updated 2019-08-14, cited 2019-10-04]. länk
  3. Sabrilex (vigabatrin). Summary of Product Characteristics. Swedish Medical Products Agency [updated 2018-06-07, cited 2019-10-04]. länk
  4. Nielsen JC, Kowalski KG, Karim A, Patel M, Wesche DL, Tolbert D. Population pharmacokinetics analysis of vigabatrin in adults and children with epilepsy and children with infantile spasms. Clin Pharmacokinet. 2014;53(11):1019-31. PubMed
  5. Morrell MJ. The new antiepileptic drugs and women: efficacy, reproductive health, pregnancy, and fetal outcome. Epilepsia. 1996;37 Suppl 6:S34-44. PubMed
  6. Kälviäinen R, Nousiainen I. Visual field defects with vigabatrin: epidemiology and therapeutic implications. CNS Drugs. 2001;15:217-30. PubMed
  7. Wild JM, Ahn HS, Baulac M, Bursztyn J, Chiron C, Gandolfo E et al. Vigabatrin and epilepsy: lessons learned. Epilepsia. 2007;48(7):1318-27. PubMed
  8. Westall CA, Wright T, Cortese F, Kumarappah A, Snead OC, Buncic JR. Vigabatrin retinal toxicity in children with infantile spasms: An observational cohort study. Neurology. 2014;83(24):2262-8. PubMed
  9. EMA. Opinion of the Committee for Proprietary Medicinal Products pursuant to article 12 of council directive 75/319/eec as amended, for Vigabatrin. 1999.
  10. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2019 [cited 2020-03-10.] länk

Författare: Linnéa Karlsson Lind

Faktagranskat av: Mia von Euler, Carl-Olav Stiller, Diana Rydberg

Godkänt av: Karin Schenck-Gustafsson