The EUROmediCAT network and databases: A Resource for Pharmacovigilance in Pregnancy

Helen Dolk; Christine Damase‐Michel; Joan Morris; Amanda Neville; Ester Garne; Sue Jordan; Anke Rissmann; Alessio Coi; Deirdre Folan; Dieuwke Broekstra; Jennifer M. Broughan; Lea Bruneau; Clara Cavero‐Carbonell; Elly den Hond; Miriam Gatt; Mika Gissler; Babak Khoshnood; Anna Latos Bielenska; Hedvig Nordeng; Ljubica Odak; Mary O'Mahony; Isabelle Perthus; J. Luke Richardson; Florence Rouget; Joanna Sichitiu; David Tucker; Natalya Zymak‐Zakutnya; Maria Loane

doi:10.1002/pds.70360

The EUROmediCAT network and databases: A Resource for Pharmacovigilance in Pregnancy

Helen Dolk
, Christine Damase‐Michel
, Joan Morris
, Amanda Neville
, Ester Garne
, Sue Jordan
, Anke Rissmann
, Alessio Coi
, Deirdre Folan
, Dieuwke Broekstra
, Jennifer M. Broughan
, Lea Bruneau
, Clara Cavero‐Carbonell
, Elly den Hond
, Miriam Gatt
, Mika Gissler
, Babak Khoshnood
, Anna Latos Bielenska
, Hedvig Nordeng
, Ljubica Odak

Mary O'Mahony, Isabelle Perthus, J. Luke Richardson, Florence Rouget, Joanna Sichitiu, David Tucker, Natalya Zymak‐Zakutnya, Maria Loane

Research output: Contribution to journal › Article › peer-review

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Abstract

BACKGROUND: The evidence gap relating to the risk of congenital anomalies (CA) associated with first trimester medication exposure in pregnancy is well recognized.

AIMS: We describe the EUROmediCAT network and databases, and the methodological approach to pregnancy pharmacovigilance.

MATERIAL AND METHODS: Multidisciplinary expertise includes CA diagnosis and epidemiology, pharmacoepidemiology, pharmacology and teratology. The EUROmediCAT central database comprises standardized data from 19 EUROCAT CA registries in 14 countries, including more than 40 000 CA cases 1995-2021 with first trimester medication exposure data recorded, and a population coverage of 14.6 million births, growing by more than 650 000 births per year. The distributed database enables federated data analysis across eight countries which can link data from CA registries to electronic healthcare data, with population coverage of up to 900 000 births per year for linkage to maternal prescriptions, of which 300 000 births per year for linkage also to data on all births.

RESULTS: The databases have enabled a variety of study designs: case-malformed control studies, cohort studies, disease cohort studies, signal detection studies, prevalence and ecological studies, and medication utilization studies.

DISCUSSION: A key strength is that studies of CA risk can address accurately the specificity of risk by type of CA.

CONCLUSION: EUROmediCAT presents a unique data and expert resource for tackling the enormous evidence gap regarding the safety of medication during pregnancy.

Original language	English
Article number	e70360
Pages (from-to)	1-30
Number of pages	30
Journal	Pharmacoepidemiology and Drug Safety
Volume	35
Issue number	5
Early online date	30 Apr 2026
DOIs	https://doi.org/10.1002/pds.70360
Publication status	Published (in print/issue) - 30 May 2026

Bibliographical note

Funding

We thank the staff, past and present, of EUROCAT congenital anomaly registries, and the funders of each registry (https://eu-rd-platform.jrc.ec.europa.eu/eurocat/eurocat-members/registries_en). We thank Prof Lolkje de Jong van den Berg for her inspirational collaboration establishing EUROmediCAT. We thank Karin Kallen for collaboration in EUROmediCAT regarding data from Sweden. The EUROmediCAT databases were established under EUFP7 grant agreement HEALTH-F5-2011-260598. The compilation of this article was part funded by the ConcePTION project under grant agreement no. 821520 with the Innovative Medicines Initiative 2 Joint Undertaking, which receives support from the European Union's Horizon2020 research and innovation program and EFPIA.

Funders	Funder number
Horizon 2020
821520

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

Pregnancy
congenital anomaly
medication safety
data sources
registries
pharmacovigilance
Humans
Databases, Factual - statistics & numerical data
pregnancy
Europe - epidemiology
Pharmacovigilance
Abnormalities, Drug-Induced - epidemiology - etiology
Pregnancy Trimester, First
Drug-Related Side Effects and Adverse Reactions - epidemiology
Pharmacoepidemiology - methods
Female
Registries
Adverse Drug Reaction Reporting Systems - statistics & numerical data
Drug-Related Side Effects and Adverse Reactions/epidemiology
Pharmacoepidemiology/methods
Adverse Drug Reaction Reporting Systems/statistics & numerical data
Databases, Factual/statistics & numerical data
Europe/epidemiology
Abnormalities, Drug-Induced/epidemiology

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Pharmacoepidemiology and Drug - 2026 - Dolk - The EUROmediCAT Network and Databases A Resource for Pharmacovigilance inFinal published version, 1.4 MB

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Dolk, H., Damase‐Michel, C., Morris, J., Neville, A., Garne, E., Jordan, S., Rissmann, A., Coi, A., Folan, D., Broekstra, D., Broughan, J. M., Bruneau, L., Cavero‐Carbonell, C., den Hond, E., Gatt, M., Gissler, M., Khoshnood, B., Bielenska, A. L., Nordeng, H., ... Loane, M. (2026). The EUROmediCAT network and databases: A Resource for Pharmacovigilance in Pregnancy. Pharmacoepidemiology and Drug Safety, 35(5), 1-30. Article e70360. https://doi.org/10.1002/pds.70360

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abstract = "BACKGROUND: The evidence gap relating to the risk of congenital anomalies (CA) associated with first trimester medication exposure in pregnancy is well recognized.AIMS: We describe the EUROmediCAT network and databases, and the methodological approach to pregnancy pharmacovigilance.MATERIAL AND METHODS: Multidisciplinary expertise includes CA diagnosis and epidemiology, pharmacoepidemiology, pharmacology and teratology. The EUROmediCAT central database comprises standardized data from 19 EUROCAT CA registries in 14 countries, including more than 40 000 CA cases 1995-2021 with first trimester medication exposure data recorded, and a population coverage of 14.6 million births, growing by more than 650 000 births per year. The distributed database enables federated data analysis across eight countries which can link data from CA registries to electronic healthcare data, with population coverage of up to 900 000 births per year for linkage to maternal prescriptions, of which 300 000 births per year for linkage also to data on all births.RESULTS: The databases have enabled a variety of study designs: case-malformed control studies, cohort studies, disease cohort studies, signal detection studies, prevalence and ecological studies, and medication utilization studies.DISCUSSION: A key strength is that studies of CA risk can address accurately the specificity of risk by type of CA.CONCLUSION: EUROmediCAT presents a unique data and expert resource for tackling the enormous evidence gap regarding the safety of medication during pregnancy.",

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Dolk, H, Damase‐Michel, C, Morris, J, Neville, A, Garne, E, Jordan, S, Rissmann, A, Coi, A, Folan, D, Broekstra, D, Broughan, JM, Bruneau, L, Cavero‐Carbonell, C, den Hond, E, Gatt, M, Gissler, M, Khoshnood, B, Bielenska, AL, Nordeng, H, Odak, L, O'Mahony, M, Perthus, I, Richardson, JL, Rouget, F, Sichitiu, J, Tucker, D, Zymak‐Zakutnya, N & Loane, M 2026, 'The EUROmediCAT network and databases: A Resource for Pharmacovigilance in Pregnancy', Pharmacoepidemiology and Drug Safety, vol. 35, no. 5, e70360, pp. 1-30. https://doi.org/10.1002/pds.70360

TY - JOUR

T1 - The EUROmediCAT network and databases: A Resource for Pharmacovigilance in Pregnancy

AU - Dolk, Helen

AU - Damase‐Michel, Christine

AU - Morris, Joan

AU - Neville, Amanda

AU - Garne, Ester

AU - Jordan, Sue

AU - Rissmann, Anke

AU - Coi, Alessio

AU - Folan, Deirdre

AU - Broekstra, Dieuwke

AU - Broughan, Jennifer M.

AU - Bruneau, Lea

AU - Cavero‐Carbonell, Clara

AU - den Hond, Elly

AU - Gatt, Miriam

AU - Gissler, Mika

AU - Khoshnood, Babak

AU - Bielenska, Anna Latos

AU - Nordeng, Hedvig

AU - Odak, Ljubica

AU - O'Mahony, Mary

AU - Perthus, Isabelle

AU - Richardson, J. Luke

AU - Rouget, Florence

AU - Sichitiu, Joanna

AU - Tucker, David

AU - Zymak‐Zakutnya, Natalya

AU - Loane, Maria

PY - 2026/5/30

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N2 - BACKGROUND: The evidence gap relating to the risk of congenital anomalies (CA) associated with first trimester medication exposure in pregnancy is well recognized.AIMS: We describe the EUROmediCAT network and databases, and the methodological approach to pregnancy pharmacovigilance.MATERIAL AND METHODS: Multidisciplinary expertise includes CA diagnosis and epidemiology, pharmacoepidemiology, pharmacology and teratology. The EUROmediCAT central database comprises standardized data from 19 EUROCAT CA registries in 14 countries, including more than 40 000 CA cases 1995-2021 with first trimester medication exposure data recorded, and a population coverage of 14.6 million births, growing by more than 650 000 births per year. The distributed database enables federated data analysis across eight countries which can link data from CA registries to electronic healthcare data, with population coverage of up to 900 000 births per year for linkage to maternal prescriptions, of which 300 000 births per year for linkage also to data on all births.RESULTS: The databases have enabled a variety of study designs: case-malformed control studies, cohort studies, disease cohort studies, signal detection studies, prevalence and ecological studies, and medication utilization studies.DISCUSSION: A key strength is that studies of CA risk can address accurately the specificity of risk by type of CA.CONCLUSION: EUROmediCAT presents a unique data and expert resource for tackling the enormous evidence gap regarding the safety of medication during pregnancy.

AB - BACKGROUND: The evidence gap relating to the risk of congenital anomalies (CA) associated with first trimester medication exposure in pregnancy is well recognized.AIMS: We describe the EUROmediCAT network and databases, and the methodological approach to pregnancy pharmacovigilance.MATERIAL AND METHODS: Multidisciplinary expertise includes CA diagnosis and epidemiology, pharmacoepidemiology, pharmacology and teratology. The EUROmediCAT central database comprises standardized data from 19 EUROCAT CA registries in 14 countries, including more than 40 000 CA cases 1995-2021 with first trimester medication exposure data recorded, and a population coverage of 14.6 million births, growing by more than 650 000 births per year. The distributed database enables federated data analysis across eight countries which can link data from CA registries to electronic healthcare data, with population coverage of up to 900 000 births per year for linkage to maternal prescriptions, of which 300 000 births per year for linkage also to data on all births.RESULTS: The databases have enabled a variety of study designs: case-malformed control studies, cohort studies, disease cohort studies, signal detection studies, prevalence and ecological studies, and medication utilization studies.DISCUSSION: A key strength is that studies of CA risk can address accurately the specificity of risk by type of CA.CONCLUSION: EUROmediCAT presents a unique data and expert resource for tackling the enormous evidence gap regarding the safety of medication during pregnancy.

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KW - congenital anomaly

KW - medication safety

KW - data sources

KW - registries

KW - pharmacovigilance

KW - Humans

KW - Databases, Factual - statistics & numerical data

KW - pregnancy

KW - Europe - epidemiology

KW - Pharmacovigilance

KW - Abnormalities, Drug-Induced - epidemiology - etiology

KW - Pregnancy Trimester, First

KW - Drug-Related Side Effects and Adverse Reactions - epidemiology

KW - Pharmacoepidemiology - methods

KW - Female

KW - Registries

KW - Adverse Drug Reaction Reporting Systems - statistics & numerical data

KW - Drug-Related Side Effects and Adverse Reactions/epidemiology

KW - Pharmacoepidemiology/methods

KW - Adverse Drug Reaction Reporting Systems/statistics & numerical data

KW - Databases, Factual/statistics & numerical data

KW - Europe/epidemiology

KW - Abnormalities, Drug-Induced/epidemiology

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DO - 10.1002/pds.70360

M3 - Article

C2 - 42057267

SN - 1053-8569

VL - 35

SP - 1

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JO - Pharmacoepidemiology and Drug Safety

JF - Pharmacoepidemiology and Drug Safety

IS - 5

M1 - e70360

ER -

The EUROmediCAT network and databases: A Resource for Pharmacovigilance in Pregnancy

Abstract

Bibliographical note

Funding

UN SDGs

Keywords

Access to Document

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The EUROmediCAT network and databases: a resource for pharmacovigilance in pregnancy Short running title: The EUROmediCAT network and databases

Cite this