A Scoping Review of Human Teratogens and Their Impact on the Developing Brain: A Contribution From the ConcePTION Project

ABSTRACT Certain medications, when used during pregnancy, are known to impact human prenatal development. Historically, little attention has been given to the impact of in utero exposure on the developing brain, despite the significance of known teratogen‐induced neurodevelopmental difficulties. Thi...

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Published in:Birth defects research Vol. 117; no. 9; pp. e2497 - n/a
Main Authors: Bluett‐Duncan, M., Adams, J., Berkovitch, M., Berlin, M., Cahoon, A., Clayton‐Smith, J., Jackson, C., Khanom, S., Mølgaard‐Nielsen, D., Richardson, J. L., Simms, V., Stellfeld, M., Winterfeld, U., Yates, L. M., Bromley, R. L.
Format: Journal Article
Language:English
Published: Hoboken, USA John Wiley & Sons, Inc 01.09.2025
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ISSN:2472-1727, 2472-1727
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Abstract ABSTRACT Certain medications, when used during pregnancy, are known to impact human prenatal development. Historically, little attention has been given to the impact of in utero exposure on the developing brain, despite the significance of known teratogen‐induced neurodevelopmental difficulties. This scoping review systematically identified and extracted neurodevelopmental outcome data for medications with established physical teratogenic effects and synthesized the key study characteristics. Medications with evidence of physical teratogenicity (n = 24) were defined by a panel of experts. Eligible studies reporting any neurodevelopmental outcomes following pregnancy exposure to the defined list of human structural teratogens were identified through electronic searches of MEDLINE and EMBASE. We identified 207 studies (254 publications) for inclusion, comprising 81 empirical cohorts and 126 case series. Concerningly, only 13 of 24 (54%) confirmed structural teratogens have been subject to any empirical investigation of neurodevelopmental outcomes. The mean time between authorization of known structural teratogens and the first empirical study investigating neurodevelopmental outcomes using a comparison group and formal data analysis is 33 years (Range: 11–64 years). When neurodevelopmental outcomes are investigated for medication exposures with physical teratogenic signatures, there are high levels of neurodevelopmental alterations (77%). These findings do not speak to a pharmacovigilance system that is functioning efficiently to identify and ameliorate neurodevelopmental risk, even for the medications with identified structural teratogenic risk. Given the high proportion of known physical teratogens exhibiting additional altered neurodevelopmental outcomes and the substantial lifetime burden of such alterations, to the individual and society, the timelines remain too long.
AbstractList Certain medications, when used during pregnancy, are known to impact human prenatal development. Historically, little attention has been given to the impact of in utero exposure on the developing brain, despite the significance of known teratogen‐induced neurodevelopmental difficulties. This scoping review systematically identified and extracted neurodevelopmental outcome data for medications with established physical teratogenic effects and synthesized the key study characteristics. Medications with evidence of physical teratogenicity ( n = 24) were defined by a panel of experts. Eligible studies reporting any neurodevelopmental outcomes following pregnancy exposure to the defined list of human structural teratogens were identified through electronic searches of MEDLINE and EMBASE. We identified 207 studies (254 publications) for inclusion, comprising 81 empirical cohorts and 126 case series. Concerningly, only 13 of 24 (54%) confirmed structural teratogens have been subject to any empirical investigation of neurodevelopmental outcomes. The mean time between authorization of known structural teratogens and the first empirical study investigating neurodevelopmental outcomes using a comparison group and formal data analysis is 33 years (Range: 11–64 years). When neurodevelopmental outcomes are investigated for medication exposures with physical teratogenic signatures, there are high levels of neurodevelopmental alterations (77%). These findings do not speak to a pharmacovigilance system that is functioning efficiently to identify and ameliorate neurodevelopmental risk, even for the medications with identified structural teratogenic risk. Given the high proportion of known physical teratogens exhibiting additional altered neurodevelopmental outcomes and the substantial lifetime burden of such alterations, to the individual and society, the timelines remain too long.
Certain medications, when used during pregnancy, are known to impact human prenatal development. Historically, little attention has been given to the impact of in utero exposure on the developing brain, despite the significance of known teratogen-induced neurodevelopmental difficulties. This scoping review systematically identified and extracted neurodevelopmental outcome data for medications with established physical teratogenic effects and synthesized the key study characteristics. Medications with evidence of physical teratogenicity (n = 24) were defined by a panel of experts. Eligible studies reporting any neurodevelopmental outcomes following pregnancy exposure to the defined list of human structural teratogens were identified through electronic searches of MEDLINE and EMBASE. We identified 207 studies (254 publications) for inclusion, comprising 81 empirical cohorts and 126 case series. Concerningly, only 13 of 24 (54%) confirmed structural teratogens have been subject to any empirical investigation of neurodevelopmental outcomes. The mean time between authorization of known structural teratogens and the first empirical study investigating neurodevelopmental outcomes using a comparison group and formal data analysis is 33 years (Range: 11-64 years). When neurodevelopmental outcomes are investigated for medication exposures with physical teratogenic signatures, there are high levels of neurodevelopmental alterations (77%). These findings do not speak to a pharmacovigilance system that is functioning efficiently to identify and ameliorate neurodevelopmental risk, even for the medications with identified structural teratogenic risk. Given the high proportion of known physical teratogens exhibiting additional altered neurodevelopmental outcomes and the substantial lifetime burden of such alterations, to the individual and society, the timelines remain too long.Certain medications, when used during pregnancy, are known to impact human prenatal development. Historically, little attention has been given to the impact of in utero exposure on the developing brain, despite the significance of known teratogen-induced neurodevelopmental difficulties. This scoping review systematically identified and extracted neurodevelopmental outcome data for medications with established physical teratogenic effects and synthesized the key study characteristics. Medications with evidence of physical teratogenicity (n = 24) were defined by a panel of experts. Eligible studies reporting any neurodevelopmental outcomes following pregnancy exposure to the defined list of human structural teratogens were identified through electronic searches of MEDLINE and EMBASE. We identified 207 studies (254 publications) for inclusion, comprising 81 empirical cohorts and 126 case series. Concerningly, only 13 of 24 (54%) confirmed structural teratogens have been subject to any empirical investigation of neurodevelopmental outcomes. The mean time between authorization of known structural teratogens and the first empirical study investigating neurodevelopmental outcomes using a comparison group and formal data analysis is 33 years (Range: 11-64 years). When neurodevelopmental outcomes are investigated for medication exposures with physical teratogenic signatures, there are high levels of neurodevelopmental alterations (77%). These findings do not speak to a pharmacovigilance system that is functioning efficiently to identify and ameliorate neurodevelopmental risk, even for the medications with identified structural teratogenic risk. Given the high proportion of known physical teratogens exhibiting additional altered neurodevelopmental outcomes and the substantial lifetime burden of such alterations, to the individual and society, the timelines remain too long.
ABSTRACT Certain medications, when used during pregnancy, are known to impact human prenatal development. Historically, little attention has been given to the impact of in utero exposure on the developing brain, despite the significance of known teratogen‐induced neurodevelopmental difficulties. This scoping review systematically identified and extracted neurodevelopmental outcome data for medications with established physical teratogenic effects and synthesized the key study characteristics. Medications with evidence of physical teratogenicity (n = 24) were defined by a panel of experts. Eligible studies reporting any neurodevelopmental outcomes following pregnancy exposure to the defined list of human structural teratogens were identified through electronic searches of MEDLINE and EMBASE. We identified 207 studies (254 publications) for inclusion, comprising 81 empirical cohorts and 126 case series. Concerningly, only 13 of 24 (54%) confirmed structural teratogens have been subject to any empirical investigation of neurodevelopmental outcomes. The mean time between authorization of known structural teratogens and the first empirical study investigating neurodevelopmental outcomes using a comparison group and formal data analysis is 33 years (Range: 11–64 years). When neurodevelopmental outcomes are investigated for medication exposures with physical teratogenic signatures, there are high levels of neurodevelopmental alterations (77%). These findings do not speak to a pharmacovigilance system that is functioning efficiently to identify and ameliorate neurodevelopmental risk, even for the medications with identified structural teratogenic risk. Given the high proportion of known physical teratogens exhibiting additional altered neurodevelopmental outcomes and the substantial lifetime burden of such alterations, to the individual and society, the timelines remain too long.
Author Cahoon, A.
Bluett‐Duncan, M.
Adams, J.
Clayton‐Smith, J.
Richardson, J. L.
Berkovitch, M.
Stellfeld, M.
Jackson, C.
Berlin, M.
Simms, V.
Mølgaard‐Nielsen, D.
Khanom, S.
Yates, L. M.
Winterfeld, U.
Bromley, R. L.
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  organization: Manchester University Hospitals NHS Foundation Trust
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  surname: Mølgaard‐Nielsen
  fullname: Mølgaard‐Nielsen, D.
  organization: Global Patient Safety, Novo Nordisk A/S
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  givenname: J. L.
  surname: Richardson
  fullname: Richardson, J. L.
  organization: UK Teratology Information Service, Newcastle Upon Tyne Hospitals NHS Foundation Trust
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  surname: Simms
  fullname: Simms, V.
  organization: Ulster University
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  fullname: Stellfeld, M.
  organization: Global Patient Safety, Novo Nordisk A/S
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  fullname: Winterfeld, U.
  organization: Lausanne University Hospital and University of Lausanne
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  surname: Yates
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  organization: KRISP, University of KwaZulu‐Natal
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  givenname: R. L.
  surname: Bromley
  fullname: Bromley, R. L.
  organization: Epilepsy Research Institute UK
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Issue 9
Keywords teratogen
neurobehavior
neurodevelopment
pharmacovigilance
pregnancy
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2025 The Author(s). Birth Defects Research published by Wiley Periodicals LLC.
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This work was supported by Innovative Medicines Initiative.
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SSID ssj0001821738
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SecondaryResourceType review_article
Snippet ABSTRACT Certain medications, when used during pregnancy, are known to impact human prenatal development. Historically, little attention has been given to the...
Certain medications, when used during pregnancy, are known to impact human prenatal development. Historically, little attention has been given to the impact of...
SourceID proquest
pubmed
crossref
wiley
SourceType Aggregation Database
Index Database
Publisher
StartPage e2497
SubjectTerms Abnormalities, Drug-Induced
Adolescent
Adult
Brain
Brain - drug effects
Brain - embryology
Brain - growth & development
Child
Data analysis
Empirical analysis
Exposure
Female
Humans
Intrauterine exposure
neurobehavior
neurodevelopment
Neurodevelopmental Disorders - chemically induced
Pharmacovigilance
Pregnancy
Prenatal development
Prenatal Exposure Delayed Effects - chemically induced
teratogen
Teratogenicity
Teratogens
Teratogens - toxicity
Title A Scoping Review of Human Teratogens and Their Impact on the Developing Brain: A Contribution From the ConcePTION Project
URI https://onlinelibrary.wiley.com/doi/abs/10.1002%2Fbdr2.2497
https://www.ncbi.nlm.nih.gov/pubmed/40960411
https://www.proquest.com/docview/3254232006
https://www.proquest.com/docview/3251462427
Volume 117
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