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First-Trimester Exposure to Gadolinium-based Contrast Agents: A Utilization Study of 4.6 Million U.S. Pregnancies.
Bird, Steven T; Gelperin, Kate; Sahin, Leyla; Bleich, Karen B; Fazio-Eynullayeva, Elnara; Woods, Corinne; Radden, Erica; Greene, Patty; McCloskey, Carolyn; Johnson, Tamara; Shinde, Mayura; Krefting, Ira.
Afiliación
  • Bird ST; From the Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmacovigilance and Epidemiology, Division of Epidemiology (S.T.B., K.G., C.W., P.G, C.M), Office of New Drugs, Division of Pediatric and Maternal Health (L.S., E.R., T.J.), and Division of Medical Imaging Pr
  • Gelperin K; From the Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmacovigilance and Epidemiology, Division of Epidemiology (S.T.B., K.G., C.W., P.G, C.M), Office of New Drugs, Division of Pediatric and Maternal Health (L.S., E.R., T.J.), and Division of Medical Imaging Pr
  • Sahin L; From the Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmacovigilance and Epidemiology, Division of Epidemiology (S.T.B., K.G., C.W., P.G, C.M), Office of New Drugs, Division of Pediatric and Maternal Health (L.S., E.R., T.J.), and Division of Medical Imaging Pr
  • Bleich KB; From the Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmacovigilance and Epidemiology, Division of Epidemiology (S.T.B., K.G., C.W., P.G, C.M), Office of New Drugs, Division of Pediatric and Maternal Health (L.S., E.R., T.J.), and Division of Medical Imaging Pr
  • Fazio-Eynullayeva E; From the Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmacovigilance and Epidemiology, Division of Epidemiology (S.T.B., K.G., C.W., P.G, C.M), Office of New Drugs, Division of Pediatric and Maternal Health (L.S., E.R., T.J.), and Division of Medical Imaging Pr
  • Woods C; From the Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmacovigilance and Epidemiology, Division of Epidemiology (S.T.B., K.G., C.W., P.G, C.M), Office of New Drugs, Division of Pediatric and Maternal Health (L.S., E.R., T.J.), and Division of Medical Imaging Pr
  • Radden E; From the Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmacovigilance and Epidemiology, Division of Epidemiology (S.T.B., K.G., C.W., P.G, C.M), Office of New Drugs, Division of Pediatric and Maternal Health (L.S., E.R., T.J.), and Division of Medical Imaging Pr
  • Greene P; From the Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmacovigilance and Epidemiology, Division of Epidemiology (S.T.B., K.G., C.W., P.G, C.M), Office of New Drugs, Division of Pediatric and Maternal Health (L.S., E.R., T.J.), and Division of Medical Imaging Pr
  • McCloskey C; From the Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmacovigilance and Epidemiology, Division of Epidemiology (S.T.B., K.G., C.W., P.G, C.M), Office of New Drugs, Division of Pediatric and Maternal Health (L.S., E.R., T.J.), and Division of Medical Imaging Pr
  • Johnson T; From the Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmacovigilance and Epidemiology, Division of Epidemiology (S.T.B., K.G., C.W., P.G, C.M), Office of New Drugs, Division of Pediatric and Maternal Health (L.S., E.R., T.J.), and Division of Medical Imaging Pr
  • Shinde M; From the Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmacovigilance and Epidemiology, Division of Epidemiology (S.T.B., K.G., C.W., P.G, C.M), Office of New Drugs, Division of Pediatric and Maternal Health (L.S., E.R., T.J.), and Division of Medical Imaging Pr
  • Krefting I; From the Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmacovigilance and Epidemiology, Division of Epidemiology (S.T.B., K.G., C.W., P.G, C.M), Office of New Drugs, Division of Pediatric and Maternal Health (L.S., E.R., T.J.), and Division of Medical Imaging Pr
Radiology ; 293(1): 193-200, 2019 10.
Article en En | MEDLINE | ID: mdl-31429682
ABSTRACT
BackgroundThe safety of gadolinium-based contrast agent (GBCA) exposure during pregnancy has not been established, and the use of GBCAs during pregnancy is not recommended unless it is essential to the health of the woman or fetus.PurposeTo examine the prevalence of GBCA exposure in a large sample of pregnancies resulting in a live birth.Materials and MethodsThe Sentinel Distributed Database was used to retrospectively identify U.S. pregnancies that resulted in live births between 2006 and 2017 from 16 data partners. The main outcome was the prevalence of MRI procedures with and without GBCAs, sorted by anatomic location and trimester, among pregnant and matched comparator women.ResultsAmong 4 692 744 pregnancies resulting in a live birth, we identified 6879 exposures to GBCAs in 5457 pregnancies, representing one contrast-enhanced MRI examination per 860 pregnancies (0.12% of all pregnancies). Most contrast-enhanced MRI examinations were performed in the head (n = 3499), although pelvic and abdominal MRI constituted 22.3% (n = 1536) of all contrast-enhanced MRI examinations during pregnancy. The majority (70.2%) of GBCA exposures occurred during the first trimester, with a 4.3-fold greater prevalence compared with that in the second trimester and a 5.1-fold greater prevalence compared with that in the third trimester.ConclusionThis study identified higher rates of gadolinium-based contrast agent (GBCA) exposure during the first few weeks of pregnancy compared with the later weeks of pregnancy, suggesting inadvertent exposure to GBCAs might occur before pregnancy is recognized.© RSNA, 2019Online supplemental material is available for this article.See also the editorial by Kallmes and Watson in this issue.
Asunto(s)

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Primer Trimestre del Embarazo / Imagen por Resonancia Magnética / Aumento de la Imagen / Medios de Contraste / Nacimiento Vivo / Gadolinio Tipo de estudio: Observational_studies / Risk_factors_studies Límite: Adult / Female / Humans / Pregnancy País/Región como asunto: America do norte Idioma: En Revista: Radiology Año: 2019 Tipo del documento: Article

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Primer Trimestre del Embarazo / Imagen por Resonancia Magnética / Aumento de la Imagen / Medios de Contraste / Nacimiento Vivo / Gadolinio Tipo de estudio: Observational_studies / Risk_factors_studies Límite: Adult / Female / Humans / Pregnancy País/Región como asunto: America do norte Idioma: En Revista: Radiology Año: 2019 Tipo del documento: Article
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