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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
,
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
Pharmacoepidemiology and Drug Safety, Volume: 35, Issue: 5
Swansea University Author: Sue Jordan
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DOI (Published version): 10.1002/pds.70360
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 Me...
| Published in: | Pharmacoepidemiology and Drug Safety |
|---|---|
| ISSN: | 1053-8569 1099-1557 |
| Published: |
Wiley
2026
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| Online Access: |
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| URI: | https://cronfa.swan.ac.uk/Record/cronfa71946 |
| first_indexed |
2026-05-18T22:04:17Z |
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2026-06-12T13:21:18Z |
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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.</abstract><type>Journal Article</type><journal>Pharmacoepidemiology and Drug Safety</journal><volume>35</volume><journalNumber>5</journalNumber><paginationStart/><paginationEnd/><publisher>Wiley</publisher><placeOfPublication/><isbnPrint/><isbnElectronic/><issnPrint>1053-8569</issnPrint><issnElectronic>1099-1557</issnElectronic><keywords>congenital anomaly; data sources; medication safety; pharmacovigilance; pregnancy; registries</keywords><publishedDay>1</publishedDay><publishedMonth>5</publishedMonth><publishedYear>2026</publishedYear><publishedDate>2026-05-01</publishedDate><doi>10.1002/pds.70360</doi><url/><notes/><college>COLLEGE NANME</college><CollegeCode>COLLEGE CODE</CollegeCode><institution>Swansea University</institution><apcterm>Another institution paid the OA fee</apcterm><funders>Seventh Framework Programme; Innovative Medicines Initiative; Ulster University</funders><projectreference/><lastEdited>2026-06-11T12:39:31.6405738</lastEdited><Created>2026-05-18T23:01:45.9804934</Created><path><level id="1">Faculty of Medicine, Health and Life Sciences</level><level id="2">School of Health and Social Care - Nursing</level></path><authors><author><firstname>Helen</firstname><surname>Dolk</surname><orcid>0000-0001-6639-5904</orcid><order>1</order></author><author><firstname>Christine</firstname><surname>Damase‐Michel</surname><orcid>0000-0001-5018-0108</orcid><order>2</order></author><author><firstname>Joan</firstname><surname>Morris</surname><orcid>0000-0002-7164-612x</orcid><order>3</order></author><author><firstname>Amanda</firstname><surname>Neville</surname><order>4</order></author><author><firstname>Ester</firstname><surname>Garne</surname><orcid>0000-0003-0430-2594</orcid><order>5</order></author><author><firstname>Sue</firstname><surname>Jordan</surname><orcid/><order>6</order></author><author><firstname>Anke</firstname><surname>Rissmann</surname><orcid>0000-0002-9437-2790</orcid><order>7</order></author><author><firstname>Alessio</firstname><surname>Coi</surname><orcid>0000-0002-9816-3144</orcid><order>8</order></author><author><firstname>Deirdre</firstname><surname>Folan</surname><order>9</order></author><author><firstname>Dieuwke</firstname><surname>Broekstra</surname><orcid>0000-0002-7134-7007</orcid><order>10</order></author><author><firstname>Jennifer M.</firstname><surname>Broughan</surname><orcid>0000-0002-4450-2147</orcid><order>11</order></author><author><firstname>Lea</firstname><surname>Bruneau</surname><orcid>0000-0002-4310-215x</orcid><order>12</order></author><author><firstname>Clara</firstname><surname>Cavero‐Carbonell</surname><orcid>0000-0002-4858-6456</orcid><order>13</order></author><author><firstname>Elly den</firstname><surname>Hond</surname><orcid>0000-0002-3909-6877</orcid><order>14</order></author><author><firstname>Miriam</firstname><surname>Gatt</surname><orcid>0000-0003-1557-9919</orcid><order>15</order></author><author><firstname>Mika</firstname><surname>Gissler</surname><orcid>0000-0001-8254-7525</orcid><order>16</order></author><author><firstname>Babak</firstname><surname>Khoshnood</surname><orcid>0000-0002-4031-4915</orcid><order>17</order></author><author><firstname>Anna Latos</firstname><surname>Bielenska</surname><orcid>0000-0002-9152-1674</orcid><order>18</order></author><author><firstname>Hedvig</firstname><surname>Nordeng</surname><orcid>0000-0001-6361-2918</orcid><order>19</order></author><author><firstname>Ljubica</firstname><surname>Odak</surname><orcid>0000-0001-9023-5142</orcid><order>20</order></author><author><firstname>Mary</firstname><surname>O'Mahony</surname><orcid>0000-0003-0574-7579</orcid><order>21</order></author><author><firstname>Isabelle</firstname><surname>Perthus</surname><orcid>0000-0002-3845-6180</orcid><order>22</order></author><author><firstname>J. 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2026-06-11T12:39:31.6405738 v2 71946 2026-05-18 The EUROmediCAT Network and Databases: A Resource for Pharmacovigilance in Pregnancy 24ce9db29b4bde1af4e83b388aae0ea1 Sue Jordan Sue Jordan true false 2026-05-18 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. Journal Article Pharmacoepidemiology and Drug Safety 35 5 Wiley 1053-8569 1099-1557 congenital anomaly; data sources; medication safety; pharmacovigilance; pregnancy; registries 1 5 2026 2026-05-01 10.1002/pds.70360 COLLEGE NANME COLLEGE CODE Swansea University Another institution paid the OA fee Seventh Framework Programme; Innovative Medicines Initiative; Ulster University 2026-06-11T12:39:31.6405738 2026-05-18T23:01:45.9804934 Faculty of Medicine, Health and Life Sciences School of Health and Social Care - Nursing Helen Dolk 0000-0001-6639-5904 1 Christine Damase‐Michel 0000-0001-5018-0108 2 Joan Morris 0000-0002-7164-612x 3 Amanda Neville 4 Ester Garne 0000-0003-0430-2594 5 Sue Jordan 6 Anke Rissmann 0000-0002-9437-2790 7 Alessio Coi 0000-0002-9816-3144 8 Deirdre Folan 9 Dieuwke Broekstra 0000-0002-7134-7007 10 Jennifer M. Broughan 0000-0002-4450-2147 11 Lea Bruneau 0000-0002-4310-215x 12 Clara Cavero‐Carbonell 0000-0002-4858-6456 13 Elly den Hond 0000-0002-3909-6877 14 Miriam Gatt 0000-0003-1557-9919 15 Mika Gissler 0000-0001-8254-7525 16 Babak Khoshnood 0000-0002-4031-4915 17 Anna Latos Bielenska 0000-0002-9152-1674 18 Hedvig Nordeng 0000-0001-6361-2918 19 Ljubica Odak 0000-0001-9023-5142 20 Mary O'Mahony 0000-0003-0574-7579 21 Isabelle Perthus 0000-0002-3845-6180 22 J. Luke Richardson 0000-0003-3494-9559 23 Florence Rouget 0000-0001-5514-0893 24 Joanna Sichitiu 0000-0002-4453-1167 25 David Tucker 0000-0003-3077-5918 26 Natalya Zymak‐Zakutnya 27 Maria Loane 0000-0002-1206-3637 28 71946__36932__78d3ab440c024a69aa02985ef6563c23.pdf 71946.VoR.pdf 2026-06-11T12:35:49.7304951 Output 1472570 application/pdf Version of Record true © 2026 The Author(s). This is an open access article under the terms of the Creative Commons Attribution License. true eng http://creativecommons.org/licenses/by/4.0/ |
| title |
The EUROmediCAT Network and Databases: A Resource for Pharmacovigilance in Pregnancy |
| spellingShingle |
The EUROmediCAT Network and Databases: A Resource for Pharmacovigilance in Pregnancy Sue Jordan |
| title_short |
The EUROmediCAT Network and Databases: A Resource for Pharmacovigilance in Pregnancy |
| title_full |
The EUROmediCAT Network and Databases: A Resource for Pharmacovigilance in Pregnancy |
| title_fullStr |
The EUROmediCAT Network and Databases: A Resource for Pharmacovigilance in Pregnancy |
| title_full_unstemmed |
The EUROmediCAT Network and Databases: A Resource for Pharmacovigilance in Pregnancy |
| title_sort |
The EUROmediCAT Network and Databases: A Resource for Pharmacovigilance in Pregnancy |
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24ce9db29b4bde1af4e83b388aae0ea1 |
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24ce9db29b4bde1af4e83b388aae0ea1_***_Sue Jordan |
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Sue Jordan |
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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 |
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| description |
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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2026-05-01T06:02:36Z |
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