Journal article 59 views 2 downloads
The EUROmediCAT Network and Databases: A Resource for Pharmacovigilance in Pregnancy
,
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
-
PDF | Version of Record
© 2026 The Author(s). This is an open access article under the terms of the Creative Commons Attribution License.
Download (1.4MB)
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
|
| Online Access: |
Check full text
|
| URI: | https://cronfa.swan.ac.uk/Record/cronfa71946 |
| 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. |
|---|---|
| Keywords: |
congenital anomaly; data sources; medication safety; pharmacovigilance; pregnancy; registries |
| College: |
Faculty of Medicine, Health and Life Sciences |
| Funders: |
Seventh Framework Programme; Innovative Medicines Initiative; Ulster University |
| Issue: |
5 |