Study identification

PURI

https://redirect.ema.europa.eu/resource/28515

EU PAS number

EUPAS8618

Study ID

28515

Official title and acronym

Lamotrigine use in Pregnancy and Risk of Orofacial Clefts II

DARWIN EU® study

No

Study countries

Belgium
Croatia
Denmark
Finland
France
Germany
Ireland
Italy
Malta
Netherlands
Norway
Portugal
Spain
Sweden
Switzerland
United Kingdom

Study description

Following a US Federal Drugs Agency alert in 2006 concerning an increased risk of orofacial cleft associated with first trimester exposure to the new anti-epileptic drug (AED) lamotrigine, the EUROCAT AED database was created in 2007 to evaluate this signal using EUROCAT data. The original database included data from 19 registries covering a population of 4 million births, 1995-2005. The database was used to conduct a case-control study evaluating the risk of orofacial clefts in relation to lamotrigine exposure. The study found no evidence of a specific increased risk of isolated orofacial clefts relative to other malformations due to lamotrigine monotherapy. In order to estimate the risk of orofacial clefts relative to other malformations more precisely and to explore whether lamotrigine exposure may be associated with other malformations, a follow-up study was commissioned. This involved 5 yearly updates (2009, 2010, 2011, 2012, and 2013). The final study included data from 21 registries and covered over 10 million births. No evidence of an increased risk of orofacial clefts relative to other malformations associated with lamotrigine exposure in the first trimester was found.

Study status

Finalised
Research institution and networks

Institutions

Networks

EUROmediCAT

Contact details

Helen Dolk

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Data analysis start date

Actual:

Date of final study report

Planned:
Actual:
Sources of funding
EU institutional research programme
Pharmaceutical company and other private sector 

More details on funding

GSK, DG Sanco
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable