Evaluation of pregnancy outcomes in patients with multiple sclerosis after fingolimod exposure
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Vile, Jere
Koren, Gideon
Guennec, Morgane
Butzkueven, Helmut
Tilson, Hugh
MacDonald, Thomas M
Hellwig, Kerstin
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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.
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Therapeutic Advances in Neurological Disorders
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11
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© The Author(s), 2018. This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (http://www.creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage).
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Neurosciences
Neurology and neuromuscular diseases
Science & Technology
Life Sciences & Biomedicine
Clinical Neurology
congenital malformations
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Geissbuhler, Y; Vile, J; Koren, G; Guennec, M; Butzkueven, H; Tilson, H; MacDonald, TM; Hellwig, K, Evaluation of pregnancy outcomes in patients with multiple sclerosis after fingolimod exposure, Therapeutic Advances in Neurological Disorders, 2018, 11, pp. 1–9