Evaluation of pregnancy outcomes in patients with multiple sclerosis after fingolimod exposure

Yvonne Geissbühler (Lead / Corresponding author), Jere Vile, Gideon Koren, Morgane Guennec, Helmut Butzkueven, Hugh Tilson, Thomas M. MacDonald, Kerstin Hellwig

Research output: Contribution to journalArticle

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Abstract

Background and Methods: Limited data are available on the safety of fingolimod in pregnant women. We estimated the risk of adverse pregnancy outcomes in women with multiple sclerosis (MS) exposed to fingolimod either shortly before or during pregnancy in prospectively collected cases from clinical trials, observational studies, surveillance programs, and spontaneous reports.

Results: The prevalence of major malformations among live births does not appear to be significantly higher than those in the general population and the unexposed MS population. Similarly, the prevalence of cardiac malformations observed in this analysis was not significantly different from that of the general population. Proportions of miscarriage were in line with those of the general and unexposed MS population and no specific pattern of birth defects was identified.

Conclusions: These data can help inform healthcare professionals and women with MS exposed to fingolimod during conception.

Original languageEnglish
Pages (from-to)1-9
Number of pages9
JournalTherapeutic Advances in Neurological Disorders
Volume11
Early online date3 Nov 2018
DOIs
Publication statusPublished - 2018

Keywords

  • congenital malformations
  • fingolimod
  • miscarriages
  • multiple sclerosis
  • pregnancy

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