CORDIS
EU research results

CORDIS

English EN
EUROmediCAT: Safety of Medication use in Pregnancy in Relation to Risk of Congenital Malformations

EUROmediCAT: Safety of Medication use in Pregnancy in Relation to Risk of Congenital Malformations

Objective

A variety of complementary approaches are needed to evaluate safety of medicine use in pregnancy. To evaluate safety in relation to teratogenicity (capacity to cause malformations), population-based congenital anomaly registers, which are already networked across Europe (EUROCAT) with a common database, can provide a cost-effective mechanism which is as yet underexploited. The enormous population coverage of registers when combined gives sufficient statistical power for the identification of associations between specific drugs and specific malformations. This project will develop and test an efficient pharmaco-vigilance system for safety of drugs during pregnancy in relation to teratogenicity by (i) enhancing the information regarding drug exposure in the EUROCAT database, covering a total population of 3 million births 1995-2010, through linkage to electronic databases containing prescription information, and by linkage to chronic disease cohorts (ii) analysing the enhanced EUROCAT database in relation to four drug groups of public health concern - new antiepileptics, insulin analogs, SSRI antidepressants, and antiasthmatics - exposure to all of which is increasing in the pregnant population (iii) interrogating health care databases to monitor the effectiveness of drug safety recommendations and pregnancy prevention programmes through drug utilisation studies, and to provide an exposure profile for pregnant women (iv) conducting a scoping study of the implications for drug safety of growing internet use by pregnant women, in terms of access to safety information about teratogenicity, and access to drugs with teratogenic potential.
Leaflet | Map data © OpenStreetMap contributors, Credit: EC-GISCO, © EuroGeographics for the administrative boundaries

Coordinator

UNIVERSITY OF ULSTER

Address

Cromore Road
Bt52 1sa Coleraine

United Kingdom

Activity type

Higher or Secondary Education Establishments

EU Contribution

€ 1 093 379,95

Administrative Contact

Anne Marie Patton (Dr.)

Participants (8)

Sort alphabetically

Sort by EU Contribution

Expand all

RIJKSUNIVERSITEIT GRONINGEN

Netherlands

EU Contribution

€ 441 261,60

UNIVERSITY OF BATH

United Kingdom

EU Contribution

€ 232 000,80

ACADEMISCH ZIEKENHUIS GRONINGEN

Netherlands

EU Contribution

€ 242 976,40

REGION SYDDANMARK

Denmark

EU Contribution

€ 333 975,75

UNIWERSYTET MEDYCZNY IM KAROLA MARCINKOWSKIEGO W POZNANIU

Poland

EU Contribution

€ 237 821,25

CONSIGLIO NAZIONALE DELLE RICERCHE

Italy

EU Contribution

€ 155 823

SWANSEA UNIVERSITY

United Kingdom

EU Contribution

€ 221 938,45

QUEEN MARY UNIVERSITY OF LONDON

United Kingdom

EU Contribution

€ 36 922,80

Project information

Grant agreement ID: 260598

Status

Closed project

  • Start date

    1 March 2011

  • End date

    28 February 2015

Funded under:

FP7-HEALTH

  • Overall budget:

    € 3 956 151,60

  • EU contribution

    € 2 996 100

Coordinated by:

UNIVERSITY OF ULSTER

United Kingdom