Journal article

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

Yvonne Geissbühler, Jere Vile, Gideon Koren, Morgane Guennec, Helmut Butzkueven, Hugh Tilson, Thomas M MacDonald, Kerstin Hellwig

Therapeutic Advances in Neurological Disorders | Published : 2018


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..

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