Lamotrigine use in Pregnancy and Risk of Orofacial Clefts II

Study identification

• 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 institutions and networks

Institutions

Centre for Maternal, Fetal and Infant Research (MFIR), 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

EUROmediCAT

Study timelines

Date when funding contract was signed

Actual:07/05/2009

Study start date

Actual:17/08/2009

Data analysis start date

Actual:29/10/2009

Date of final study report

Planned:15/03/2015

Actual:15/03/2015

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