Surveillance of Adverse Fetal Effects of Medications (SAFE-Med): findings from the International Clearinghouse of Birth Defects Surveillance and Research (ICBDSR). (Articolo in rivista)

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  • Surveillance of Adverse Fetal Effects of Medications (SAFE-Med): findings from the International Clearinghouse of Birth Defects Surveillance and Research (ICBDSR). (Articolo in rivista) (literal)
Anno
  • 2010-01-01T00:00:00+01:00 (literal)
Http://www.cnr.it/ontology/cnr/pubblicazioni.owl#doi
  • 10.1016/j.reprotox.2010.03.005 (literal)
Alternative label
  • Alessandra Lisi a, Lorenzo D. Botto b, Elisabeth Robert-Gnansia c, Eduardo E. Castilla d,e, Marian K. Bakker f, Sebastiano Bianca g, Guido Cocchi h, Caterine de Vigan i, Maria da Graca Dutra e, Jiri Horacek j, Paul Merlob k, Anna Pierini l, Gioacchino Scarano m,n, Antonin Sipek o, Michiko Yamanaka p, Pierpaolo Mastroiacovo a (2010)
    Surveillance of Adverse Fetal Effects of Medications (SAFE-Med): findings from the International Clearinghouse of Birth Defects Surveillance and Research (ICBDSR).
    in Reproductive toxicology (Elmsford, N.Y.); Elsevier Inc., San Diego (Stati Uniti d'America)
    (literal)
Http://www.cnr.it/ontology/cnr/pubblicazioni.owl#autori
  • Alessandra Lisi a, Lorenzo D. Botto b, Elisabeth Robert-Gnansia c, Eduardo E. Castilla d,e, Marian K. Bakker f, Sebastiano Bianca g, Guido Cocchi h, Caterine de Vigan i, Maria da Graca Dutra e, Jiri Horacek j, Paul Merlob k, Anna Pierini l, Gioacchino Scarano m,n, Antonin Sipek o, Michiko Yamanaka p, Pierpaolo Mastroiacovo a (literal)
Pagina inizio
  • 433 (literal)
Pagina fine
  • 442 (literal)
Http://www.cnr.it/ontology/cnr/pubblicazioni.owl#url
  • http://www.sciencedirect.com/science/article/pii/S089062381000047X (literal)
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  • 29 (literal)
Rivista
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  • In: Reproductive Toxicology, vol. Available online 27 March 2010 pp. 1 - 10. Elsevier, 2010. (literal)
Http://www.cnr.it/ontology/cnr/pubblicazioni.owl#pagineTotali
  • 10 (literal)
Http://www.cnr.it/ontology/cnr/pubblicazioni.owl#numeroFascicolo
  • 4 (literal)
Note
  • PubMe (literal)
Http://www.cnr.it/ontology/cnr/pubblicazioni.owl#affiliazioni
  • a Centre of the International Clearinghouse for Birth Defects Surveillance and Research - ICBDSR, Via Carlo Mirabello, 19, 00195 Rome, Italy; b Division of Medical Genetics, Department of Pediatrics, University of Utah, School of Medicine, Salt Lake City, UT, United States; c REMERA: REgistre des Malformations En Rhône-Alpes, Faculté de Médecine Laennec, Lyon, France; d CEMIC, Buenos Aires, Argentina; e ECLAMC-FIOCRUZ, Rio de Janeiro, Brazil; f EUROCAT Northern Netherlands, Department of Genetics, University Medical Centre Groningen, University of Groningen, The Netherlands; g ISMAC Registry, Genetica Medica, ARNAS Garibaldi Nesima, Catania, Italy; h IMER, Institute of Neonatology and Preventive Pediatric Health Care, Bologna University, Bologna, Italy; i INSERM, Epidemiological Research Unit on Perinatal and Women's Health, Villejuif, France; j National Registry of Congenital Anomalies in the Czech Republic, Postgraduate Medical Institute, Medical Genetics, Prague, Czech Republic; k Department of Neonatology, Rabin Medical Center, Beilinson Campus, Petah Tikva, Israel; l Institute of Clinical Physiology, Unit of Epidemiology, CNR Area di Ricerca di San Cataldo, Pisa, Italy; m Campania Birth Defects Register, Division of Medical Genetics, General Hospital \"G.Rummo\" Benevento, Italy; n Regional Epidemiologic Observatory, Health Council, Benevento, Italy; o National Registry of Congenital Anomalies in the Czech Republic, Department of Medical Genetics, Thomayer's University Hospital, Prague, Czech Republic; p Kanawaga Children's Medical Center, Division of Obstetrics and Gynecology, Yokohama City, Japan; (literal)
Titolo
  • Surveillance of Adverse Fetal Effects of Medications (SAFE-Med): findings from the International Clearinghouse of Birth Defects Surveillance and Research (ICBDSR). (literal)
Abstract
  • 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. (literal)
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