Study identification

PURI

https://redirect.ema.europa.eu/resource/8616

EU PAS number

EUPAS8615

Study ID

8616

Official title and acronym

Lamotrigine use in Pregnancy and Risk of Orofacial Clefts

DARWIN EU® study

No

Study countries

Belgium
Croatia
Denmark
France
Germany
Ireland
Italy
Malta
Netherlands
Norway
Poland
Spain
Switzerland
United Kingdom

Study description

A case-malformed control study evaluating the risk of orofacial clefts in relation to first trimester exposure to the the new anti-epileptic drug (AED) lamotrigine was conducted using data from 19 EUROCAT registries covering a population of 4 million births, 1995-2005. The study found no evidence of a specific increased risk of isolated orofacial clefts relative to other malformations due to lamotrigine monotherapy. This study was conducted following a US Federal Drugs Agency alert in 2006 concerning an increased risk of orofacial cleft associated with lamotrigine exposure.

Study status

Finalised
Research institutions and networks

Institutions

Ulster University
United Kingdom (Northern Ireland)
First published:
20/03/2024
InstitutionEducational Institution

Networks

Contact details

Helen Dolk

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Actual:

Data analysis start date

Actual:

Date of final study report

Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

GSK
Regulatory

Was the study required by a regulatory body?

No