| Surveillance of adverse fetal effects of medications (SAFE-Med): findings from the international Clearinghouse of birth defects surveillance and research. | |
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MedLine Citation:
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PMID: 20347959 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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To evaluate whether the routinely collected data in birth defect registries could be used to assess association between medications and risk for congenital anomalies an "exposed case-only" design was performed. Twelve registries provided 18,131 cases exposed to a medication during the first trimester of pregnancy and with at least one major malformation. Odds ratios for malformations associated with maternal use of selected medications were computed. Among seven most commonly used medications very few significant associations with malformations were identified. Among fourteen potentially teratogenic medications several strong associations were found, including valproic acid with spina bifida, and insulin (as proxy for diabetes) with several types of cardiac defects. Finding known associations provides assurance on the validity of this approach, whereas identifying new associations provides a signal to be followed by confirmatory studies. Through this activity, international networks of birth defect registries can contribute with limited resources to post-marketing surveillance of the teratogenicity of medications. |
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Authors:
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Alessandra Lisi; Lorenzo D Botto; Elisabeth Robert-Gnansia; Eduardo E Castilla; Marian K Bakker; Sebastiano Bianca; Guido Cocchi; Caterine de Vigan; Maria da Graça Dutra; Jiri Horacek; Paul Merlob; Anna Pierini; Gioacchino Scarano; Antonin Sipek; Michiko Yamanaka; Pierpaolo Mastroiacovo |
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Publication Detail:
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Type: Journal Article; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S. Date: 2010-03-27 |
Journal Detail:
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Title: Reproductive toxicology (Elmsford, N.Y.) Volume: 29 ISSN: 1873-1708 ISO Abbreviation: Reprod. Toxicol. Publication Date: 2010 Jul |
Date Detail:
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Created Date: 2010-06-23 Completed Date: 2010-09-21 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 8803591 Medline TA: Reprod Toxicol Country: United States |
Other Details:
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Languages: eng Pagination: 433-42 Citation Subset: IM |
Affiliation:
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Centre of the International Clearinghouse for Birth Defects Surveillance and Research - ICBDSR, Via Carlo Mirabello, 19, 00195 Rome, Italy. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Abnormalities, Drug-Induced
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epidemiology*,
etiology Congenital Abnormalities / epidemiology*, etiology Databases, Factual / statistics & numerical data* Female Humans Infant, Newborn Male Pharmaceutical Preparations / adverse effects* Population Surveillance* Pregnancy Product Surveillance, Postmarketing* Registries |
| Grant Support | |
ID/Acronym/Agency:
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1U50DD000524-01/DD/NCBDD CDC HHS; U50/CCU207141//PHS HHS |
| Chemical | |
Reg. No./Substance:
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0/Pharmaceutical Preparations |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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