| Pregnancy outcomes in multiple sclerosis following subcutaneous interferon beta-1a Therapy. | |
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MedLine Citation:
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PMID: 21220368 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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Background: Women with multiple sclerosis (MS) are advised to discontinue interferon-beta therapy before trying to conceive. Unplanned pregnancies occur and risks related to exposure remain unclear. Methods: To determine pregnancy outcomes following interferon-beta therapy, we examined pregnancies from a global drug safety database containing individual case safety reports received in the post-marketing setting and safety data from clinical trials of subcutaneous interferon beta-1a in MS. Results: One thousand and twenty-two cases of exposure to subcutaneous interferon beta-1a during pregnancy were retrieved; 679 had a documented outcome. In cases for which exposure duration was available (n = 231), mean time of foetal exposure to subcutaneous interferon beta-1a before treatment discontinuation was 28 days; most pregnancies (199/231; 86.1%) were exposed for ≤45 days. To avoid bias, only outcomes for prospective data (n = 425) in pregnancies exposed to interferon beta-1a in utero were analysed further. Of these, 324 (76.2%) resulted in normal live births and four (0.9%) in live births with congenital anomalies (3 [0.7%] were 'major'). Four (0.9%) pregnancies resulted in stillbirths (1 [0.2%] with foetal defects). There were 5 (1.2%) ectopic pregnancies, 49 (11.5%) spontaneous abortions and 39 (9.2%) elective terminations. Most pregnancies exposed to subcutaneous interferon beta-1a in utero were associated with normal live births. The rates of spontaneous abortion and major congenital anomalies in live births were in line with those observed in the general population. Conclusions: These data should be taken into account when considering options for women with MS who become pregnant or who are planning pregnancy while on treatment with subcutaneous interferon beta-1a. |
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Authors:
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Magnhild Sandberg-Wollheim; Enrica Alteri; Margaretha Stam Moraga; Gabrielle Kornmann |
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Publication Detail:
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Type: JOURNAL ARTICLE Date: 2011-1-10 |
Journal Detail:
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Title: Multiple sclerosis (Houndmills, Basingstoke, England) Volume: - ISSN: 1477-0970 ISO Abbreviation: - Publication Date: 2011 Jan |
Date Detail:
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Created Date: 2011-1-11 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9509185 Medline TA: Mult Scler Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Affiliation:
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Department of Neurology, University Hospital, Lund, Sweden. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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