| Pharmacovigilance in pregnancy: adverse drug reactions associated with fetal disorders. | |
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MedLine Citation:
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PMID: 23027583 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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Abstract Objective: To provide the first update on drug safety profiles and adverse drug reactions (ADRs) associated with fetal disorders from the Swiss national ADR database. Methods: We conducted a retrospective study using data from 202 pharmacovigilance reports on drug-associated fetal disorders from the Swiss national ADR database from 1990 to 2009. Evaluated aspects included administrative information on the report, drug exposure, and disorders. Results: The ADR reporting frequency on the topic of fetal disorders has increased during the last 20 years, from only 1 report in 1991 to a maximum of 31 reports in 2008. Nervous system drugs were the most frequently reported drug group (40.2%) above all antidepressants and antiepileptics. The highest level of overall drug intake could be observed for the 1st trimester (85.4%), especially for the first 6 weeks of pregnancy. The most frequently reported types of fetal disorders were malformations (68.8%), especially those of the musculoskeletal and circulatory systems. A positive association was discovered between antiepileptics and malformations in general and in particular of the circulatory system and the eye, ear, face, and neck. Conclusions: The results suggest that the nervous system drug group bears an especially high risk for malformations. The most commonly identified drug exposures can help focus pharmacoepidemiologic efforts in drug-induced birth defects. |
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Authors:
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Carmen Wettach; Janine Thomann; Claudia Lambrigger-Steiner; Thierry Buclin; Jules Desmeules; Ursula von Mandach |
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Publication Detail:
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Type: JOURNAL ARTICLE Date: 2012-10-2 |
Journal Detail:
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Title: Journal of perinatal medicine Volume: 0 ISSN: 1619-3997 ISO Abbreviation: J Perinat Med Publication Date: 2012 Oct |
Date Detail:
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Created Date: 2012-10-2 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 0361031 Medline TA: J Perinat Med Country: - |
Other Details:
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Languages: ENG Pagination: 1-7 Citation Subset: - |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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