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Evolving knowledge of the teratogenicity of medications in human pregnancy


  • Margaret P. Adam,

    Corresponding author
    • Seattle Children's Hospital, 4800 Sand Point Way NE, PO Box 5371/A7937, Seattle, WA 98105-0371.
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    • Margaret P. Adam, M.D. is an Associate Professor of Pediatrics, Division of Genetic Medicine, at the University of Washington in Seattle, WA. She is involved in several ongoing research studies pertaining to clinical teratology.

  • Janine E. Polifka,

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    • Janine E. Polifka, Ph.D. is Director of TERIS (The Teratogen Information System) at the Department of Pediatrics and the Center on Human Development & Disability at the University of Washington in Seattle, WA. She has published numerous articles in the area of Clinical Teratology.

  • J.M. Friedman

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    • Jan M. Friedman, M.D., Ph.D. is Professor of Medical Genetics at the University of British Columbia. He is currently Acting Executive Director of the Child & Family Research Institute and Acting Associate Dean (Research) in the UBC Faculty of Medicine. Dr. Friedman was the Founding President of the Association of Professors of Human Genetics and has served as President of the Canadian College of Medical Geneticists and President of the Teratology Society. His research includes studies of the effects of various medications on human embryonic and fetal development, clinical and epidemiological studies of neurofibromatosis, and the use of genomic technologies to identify the causes of intellectual disability.

  • How to cite this article: Adam MP, Polifka JE, Friedman JM. 2011. Evolving knowledge of the teratogenicity of medications in human pregnancy. Am J Med Genet Part C Semin Med Genet 157:175–182.


A majority of pregnant women take at least one medication during pregnancy, although the safety of such drugs during pregnancy is not always known. We reviewed the safety during pregnancy of 172 drugs approved by the US Food and Drug Administration (FDA) from 2000 to 2010 using the TERIS risk rating system. We also reviewed safety information for 468 drugs approved by the FDA from 1980 to 2000 to determine if revisions in risk categories had been made in the last 10 years. The teratogenic risk in human pregnancy was “undetermined” for 168 (97.7%) of drug treatments approved between 2000 and 2010. Furthermore, the amount of data available regarding safety in pregnancy was rated as “none” for 126 (73.3%) of these drugs. For those drugs approved between 1980 and 2000, only 23 (5%) changed a full risk category or more in the past 10 years. Sources of data that led to a revised risk were derived from exposure cohort studies performed through record linkage studies, teratogen information services, large population-based case-control studies, and pregnancy registries. The mean time for a treatment initially classified as having an “undetermined” risk to be assigned a more precise risk was 27 years (95% confidence interval 26–28 years). The lack of information needed to assess the safety of drug treatments during human pregnancy remains a serious public health problem. A more active approach to post-marketing surveillance for teratogenic effects is necessary. © 2011 Wiley-Liss, Inc.

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