Lamotrigine use in Pregnancy and Risk of Orofacial Clefts

Study identification

• 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)

Networks

European Surveillance of Congenital Anomalies (EUROCAT)

Austria

Belgium

Croatia

Czechia

Denmark

Finland

France

Germany

Hungary

Ireland

Italy

Malta

Netherlands

Norway

Poland

Portugal

Spain

Sweden

Switzerland

United Kingdom

Study timelines

Date when funding contract was signed

Planned:07/02/2007

Actual:07/02/2007

Study start date

Actual:15/02/2007

Data analysis start date

Actual:18/04/2007

Date of final study report

Actual:31/07/2007

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GSK

Regulatory

• Was the study required by a regulatory body?:
  No