| Monitoring for teratogenic signals: Pregnancy registries and surveillance methods. | |
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MedLine Citation:
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PMID: 21766431 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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Pregnant women should have access to medications that have been adequately studied for use to facilitate evidence-based risk-benefit discussions with their health care providers. Pregnant women experience acute medical emergencies, have existing conditions that require continued medical treatment or may develop pregnancy-induced conditions, making drug use during pregnancy unavoidable. Drug labeling is the primary source of information about a drug's use. The safety and efficacy data found in the label is derived from well-controlled clinical trials conducted prior to a drug's approval. However, pregnant women are rarely enrolled in clinical trials unless a product is specifically indicated for a pregnancy-related condition. Consequently, information regarding a product's use during pregnancy is usually collected postapproval. Current data collection tools include pregnancy exposure registries, retrospective cohort studies, pregnancy surveillance programs, case-control studies, spontaneous reports of adverse events and case reports. Each tool has strengths and limitations in its ability to detect teratogenic signals. Combinations of different sources of data are necessary to acquire the most complete picture of potential teratogenic risk, as no single method can capture all desired data to help pregnant patients and women of child bearing potential make appropriate risk benefits decisions along with their health care providers. Published 2011 Wiley-Liss, Inc. |
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Authors:
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Tammie B Howard; Melissa S Tassinari; Karen B Feibus; Lisa L Mathis |
Publication Detail:
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Type: JOURNAL ARTICLE Date: 2011-7-15 |
Journal Detail:
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Title: American journal of medical genetics. Part C, Seminars in medical genetics Volume: - ISSN: 1552-4876 ISO Abbreviation: - Publication Date: 2011 Jul |
Date Detail:
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Created Date: 2011-7-18 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 101235745 Medline TA: Am J Med Genet C Semin Med Genet Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Copyright Information:
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This article is a US Government work and, as such, is in the public domain in the United States of America. Published 2011 Wiley-Liss, Inc. |
Affiliation:
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FDA-Pediatric and Maternal Health Staff, 10903 New Hampshire Ave, Silver Spring, MD 20993. |
Export Citation:
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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