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Influencing clinical practice regarding the use of antiepileptic medications during pregnancy: Modeling the potential impact on the prevalences of spina bifida and cleft palate in the United States§

Authors

  • Suzanne M. Gilboa,

    Corresponding author
    • National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention, Mail Stop E-86, 1600 Clifton Road, Atlanta, GA 30333.
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    • Suzanne M. Gilboa, Ph.D., M.H.S., is an Epidemiologist in the Division of Birth Defects and Developmental Disabilities at the Centers for Disease Control and Prevention (CDC). Her research focuses on understanding risk factors for birth defects, including diabetes and obesity, environmental and occupational hazards and exposures, and medication use.

  • Cheryl S. Broussard,

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    • Cheryl S. Broussard, Ph.D., is a Health Scientist in the Division of Birth Defects and Developmental Disabilities at CDC. She joined CDC in 2007 as an Epidemic Intelligence Service officer in the Birth Defects Branch, where she focused on studying usage patterns and health outcomes associated with medication use during pregnancy. She currently chairs medication workgroups for both the National Birth Defects Prevention Study and CDC's Birth Defects Branch.

  • Owen J. Devine,

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    • Owen J. Devine, Ph.D., is a Mathematical Statistician in the National Center on Birth Defects and Developmental Disabilities at CDC. His areas of research include the application of mathematical modeling techniques to public health challenges with an emphasis on the uncertainty associated with model-based estimates.

  • Kara N. Duwe,

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    • Kara N. Duwe, M.P.H., is an Epidemiologist in the Division of Birth Defects and Developmental Disabilities at CDC. Her research focuses on understanding risk factors for birth defects, including medication use, smoking, and environmental exposures. She also works on health communication activities to promote new study findings.

  • Audrey L. Flak,

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    • Audrey L. Flak, M.P.H., is an Oak Ridge Institute for Science and Education fellow in the Division of Birth Defects and Developmental Disabilities at CDC. Her primary research interest is the relationship between environmental exposures and reproductive health outcomes.

  • Sheree L. Boulet,

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    • Sheree L. Boulet, Dr.P.H., M.P.H., is an Epidemiologist in the Division of Blood Disorders at the National Center on Birth Defects and Developmental Disabilities at CDC. Her research interests include preconception health, fetal growth restriction, macrosomia, and the health impact of chronic conditions in pediatric populations.

  • Cynthia A. Moore,

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    • Cynthia A. Moore, M.D., Ph.D., is the Associate Director of Science in the Division of Birth Defects and Developmental Disabilities at CDC. Dr. Moore is a pediatrician and clinical geneticist. Her areas of research are birth defects and genetic disease epidemiology and her activities have focused on mechanisms of morphogenesis, classification of birth defects and genetic syndromes, prevention strategies for exposure to teratogens, and genetic and environmental risk factors for birth defects.

  • Martha M. Werler,

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    • Martha M. Werler, Sc.D., is a Professor of Epidemiology at Boston University Slone Epidemiology Center. Her work includes epidemiologic studies on a wide variety of risk factors for birth defects, with particular focus on medication use during pregnancy. She also conducts follow-up studies of outcomes among children born with birth defects.

  • Margaret A. Honein

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    • Margaret (Peggy) A. Honein, Ph.D., M.P.H., is an Epidemiologist and Chief of the Birth Defects Branch in the Division of Birth Defects and Developmental Disabilities at CDC. Her research interests include the role of smoking in birth defects, assessing the safety or risk of medication use during pregnancy, understanding longer term outcomes associated with major birth defects, and evaluating the effects of infections, such as influenza, during pregnancy.


  • This article is a US Government work and, as such, is in the public domain in the United States of America.

  • Disclaimer: The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.

  • §

    How to cite this article: Gilboa SM, Broussard CS, Devine OJ, Duwe KN, Flak AL, Boulet SL, Moore CA, Werler MM, Honein MA. 2011. Influencing clinical practice regarding the use of antiepileptic medications during pregnancy: Modeling the potential impact on the prevalences of spina bifida and cleft palate in the United States. Am J Med Genet Part C Semin Med Genet 157:234–246.

Abstract

Selected antiepileptic drugs (AEDs) increase the risk of birth defects. To assess the impact of influencing AED prescribing practices on spina bifida and cleft palate we searched the literature for estimates of the association between valproic acid or carbamazepine use during pregnancy and these defects and summarized the associations using meta-analyses. We estimated distributions of the prevalence of valproic acid and carbamazepine use among women of childbearing age based on analyses of four data sets. We estimated the attributable fractions and the number of children born with each defect that could be prevented annually in the United States if valproic acid and carbamazepine were not used during pregnancy. The summary odds ratio estimate for the association between valproic acid and spina bifida was 11.9 (95% uncertainty interval (UI): 4.0–21.2); for valproic acid and cleft palate 5.8 (95% UI: 3.3–9.5); for carbamazepine and spina bifida 3.6 (95% UI: 1.3–7.8); and for carbamazepine and cleft palate 2.4 (95% UI: 1.1–4.5) in the United States. Approximately 40 infants (95% UI: 10–100) with spina bifida and 35 infants (95% UI: 10–70) with cleft palate could be born without these defects each year if valproic acid were not used during pregnancy; 5 infants (95% UI: 0–15) with spina bifida and 5 infants (95% UI: 0–15) with cleft palate could be born without these defects each year if carbamazepine were not used during pregnancy. This modeling approach could be extended to other medications to estimate the impact of translating pharmacoepidemiologic data to evidence-based prenatal care practice. Published 2011 Wiley-Liss, Inc.

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