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Volumn 103, Issue 8, 2015, Pages 718-720

Assessing congenital malformation risk from medications used in pregnancy: The contribution of NBDPS in pregnancy labeling of prescription drug products

Author keywords

FDA; NBDPS; Pregnancy labeling

Indexed keywords

NARCOTIC ANALGESIC AGENT; PARACETAMOL; PRESCRIPTION DRUG;

EID: 84939229658     PISSN: 15420752     EISSN: 15420760     Source Type: Journal    
DOI: 10.1002/bdra.23403     Document Type: Article
Times cited : (2)

References (12)
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  • 2
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    • FDA Drug Safety Communications. 2015. FDA has reviewed possible risks of pain medicine use during pregnancy. 01/09/2015. Available at: http://www.fda.gov/Drugs/DrugSafety/ucm429117.htm. Accessed March 4, 2015.
    • (2015) FDA has reviewed possible risks of pain medicine use during pregnancy
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    • Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products
    • Federal Register. 2006. Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products. Federal Register 71:3922-3929.
    • (2006) Federal Register , vol.71 , pp. 3922-3929
  • 4
    • 84922324359 scopus 로고    scopus 로고
    • Content and format of labeling for human prescription drug and biological products: requirements for pregnancy and lactation labeling
    • Federal Register. 2014. Content and format of labeling for human prescription drug and biological products: requirements for pregnancy and lactation labeling. Fed Regist 79:72064-72103.
    • (2014) Fed Regist , vol.79 , pp. 72064-72103
  • 8
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    • Acetaminophen use during pregnancy: effects on risk for congenital abnormalities
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    • (2008) Am J Obstet Gynecol , vol.198 , pp. 178e1-178e7
    • Rebordosa, C.1    Kogevinas, M.2    Horváth-Puhó, E.3
  • 9
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    • Reefhuis J, Gilboa SM, Anderka M, et al. 2015. The National Birth Defects Prevention Study: a review of the methods. Birth Defects Res Part A Clin Mol Teratol doi: 10.1002/bdra.23384. [Epub ahead of print].
    • (2015) Birth Defects Res Part A Clin Mol Teratol
    • Reefhuis, J.1    Gilboa, S.M.2    Anderka, M.3
  • 10
    • 84901625294 scopus 로고    scopus 로고
    • The National Birth Defects Prevention Study: how to communicate data
    • Scialli AR. 2014. The National Birth Defects Prevention Study: how to communicate data. Semin Fetal Neonatal Med 19:170e176.
    • (2014) Semin Fetal Neonatal Med , vol.19 , pp. 170e176
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  • 11
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    • Evaluation of human teratogenic risk in animals
    • In: Lee DH, Hewson EW, Okum D, editors. . 1st ed. New York: Academic Press.
    • Wilson JG. 1973. Evaluation of human teratogenic risk in animals. In: Lee DH, Hewson EW, Okum D, editors. Environment and birth defects. 1st ed. New York: Academic Press. pp. 146-160.
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  • 12
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    • Periconceptional use of opioids and the risk of neural tube defects
    • Yazdy MM, Mitchell AA, Tinker SC, et al. 2013. Periconceptional use of opioids and the risk of neural tube defects. Obstet Gynecol 122:838-844.
    • (2013) Obstet Gynecol , vol.122 , pp. 838-844
    • Yazdy, M.M.1    Mitchell, A.A.2    Tinker, S.C.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.