Surveillance of adverse fetal effects of medications (SAFE-Med): Findings from the International Clearinghouse of Birth Defects Surveillance and Research

dc.creatorLisi, Alessandra
dc.creatorBotto, Lorenzo D.
dc.creatorRobert-Gnansia, Elisabeth
dc.creatorCastilla, Eduardo E.
dc.creatorBakker, Marian K.
dc.creatorBianca, Sebastiano
dc.creatorCocchi, Guido
dc.creatorVigan, Caterine de
dc.creatorDutra, Maria da Graça
dc.creatorHoracek, Jiri
dc.creatorMerlob, Paul
dc.creatorPierini, Anna
dc.creatorScarano, Gioacchino
dc.creatorSipek, Antonin
dc.creatorYamanaka, Michiko
dc.creatorMastroiacovo, Pierpaolo
dc.date2017-10-05T10:53:46Z
dc.date2017-10-05T10:53:46Z
dc.date2010
dc.date.accessioned2023-09-26T20:20:54Z
dc.date.available2023-09-26T20:20:54Z
dc.identifierLISI, Alessandra; et al. Surveillance of adverse fetal effects of medications (SAFE-Med): Findings from the International Clearinghouse of Birth Defects Surveillance and Research.. Reproductive Toxicology, v.29, p.433–442, 2010.
dc.identifier0890-6238
dc.identifierhttps://www.arca.fiocruz.br/handle/icict/22773
dc.identifier1873-1708
dc.identifier.urihttps://repositorioslatinoamericanos.uchile.cl/handle/2250/8854817
dc.descriptionTo 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.
dc.description2030-01-01
dc.formatapplication/pdf
dc.languageeng
dc.publisherElsevier
dc.rightsrestricted access
dc.subjectMedicamentos
dc.subjectMedicação
dc.subjectAnormalidades Congênitas
dc.subjectCuidado Pré-Concepcional
dc.subjectVigilância pós-comercialização
dc.subjectteratogene
dc.subjectTeratogen
dc.subjectDrug
dc.subjectMedication
dc.subjectBirth defect
dc.subjectPreconception
dc.subjectPost-marketing surveillance
dc.titleSurveillance of adverse fetal effects of medications (SAFE-Med): Findings from the International Clearinghouse of Birth Defects Surveillance and Research
dc.typeArticle


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