Evidence map›Paper›PMID 40960411›Full record

ArticleBirth defects research2025

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

M Bluett-Duncan, J Adams, M Berkovitch, M Berlin, A Cahoon, J Clayton-Smith, C Jackson, S Khanom, D Mølgaard-Nielsen, J L Richardson and 5 more

Abstract readScoping Review
In one paragraph

Article in Birth defects research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

M Bluett-DuncanDivision of Neuroscience, School of Biological Sciences, The University of Manchester, Manchester, UK.ORCID 0000-0002-7539-6746
J AdamsDepartment of Psychology, University of Massachusetts Boston, Boston, MA, USA.
M BerkovitchClinical Pharmacology and Toxicology Unit, TIS Zerifin, Shamir Medical Center (Assaf Harofeh), Zerifin, Affiliated to the School of Medicine, Faculty of Medical and Health Sciences, Tel Aviv University, Tel Aviv, Israel.ORCID 0000-0001-9579-383X
M BerlinClinical Pharmacology and Toxicology Unit, TIS Zerifin, Shamir Medical Center (Assaf Harofeh), Zerifin, Affiliated to the School of Medicine, Faculty of Medical and Health Sciences, Tel Aviv University, Tel Aviv, Israel.
A CahoonSchool of Psychology, Faculty of Life and Health Sciences, Ulster University, Coleraine, UK.
J Clayton-SmithManchester Centre for Genomic Medicine, University of Manchester, St Mary's Hospital, Manchester, UK.
C JacksonThe Walton Centre for Neurology and Neurosurgery, Liverpool, UK.
S KhanomRoyal Manchester Children's Hospital, Manchester University Hospitals NHS Foundation Trust, Manchester, UK.
D Mølgaard-NielsenGlobal Patient Safety, Novo Nordisk A/S, Soeborg, Denmark.
J L RichardsonUK Teratology Information Service, Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.
V SimmsSchool of Psychology, Faculty of Life and Health Sciences, Ulster University, Coleraine, UK.
M StellfeldGlobal Patient Safety, Novo Nordisk A/S, Soeborg, Denmark.
U WinterfeldSwiss Teratogen Information Service, Clinical Pharmacology Service, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
L M YatesThe Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.
R L BromleyDivision of Neuroscience, School of Biological Sciences, The University of Manchester, Manchester, UK.

Funding

Innovative Medicines Initiative
6 · The paper itself

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.

Indexed as

BrainTeratogensAbnormalities, Drug-InducedAdolescentAdultChildFemaleHumansNeurodevelopmental DisordersPregnancyPrenatal Exposure Delayed EffectsTeratogensneurobehaviorneurodevelopmentpharmacovigilancepregnancyteratogen

Identifiers

PMID40960411
PMCPMC12442749

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.