EUROCAT Lamotrigine Study Phase II

In January 2007 EUROCAT started to develop the EUROCAT Antiepileptic Drug Database. With this database we performed a case-control study (The EUROCAT Lamotrigine Study Phase I) to test if the hypothesis of a very high increased risk of orofacial clefts after first trimester lamotrigine exposure. In this lamotrigine study Phase I we did not find a significantly increased risk for orofacial clefts relative to other malformations, nor of cleft palate specifically, in relation with first trimester lamotrigine use (Dolk et al 2008).

Aim of this study  is to expand the EUROCAT Antiepileptic Drug Database by including more years and thereby investigate with greater statistical power than the previous EUROCAT study.