Felbamate (Epilepsy = ALL indications)

Exposed non-exposed studies (cohort)

Study Country
Study period
Population source Exposure definition Non-exposure definition Sample size Rmk
Katz (Felbamate), 2001 USA
1990 - 2000
The clinical histories of women with epilepsy cared for at the center, contributing 103 newborns during the study period. Newborn of women with epilepsy exposed to felbamate monotherapy during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). exposed to other treatment, sick
Newborn of women with epilepsy exposed to lamotrigine monotherapy during pregnancy.
5 / 3 The analysis of developmental delay excluded the 20 pregnancies occurring within 1 year of chart review because of insufficient time to evaluate developmental milestones.
Tomson (Felbamate), 2018 42 countries
1999 - 2016
Pregnancies registered in the database during the study period who had been exposed to antiepileptic drug monotherapy and had complete follow-up data up to 1 year. They were enrolled within gestation week 16 and before fetal outcome is known. Offspring exposed in utero to felbamate monotherapy during the first trimester and born from epileptic mothers. (This is a subgroup of exposure among the whole exposed group considered in the study). exposed to other treatment, sick
Offspring exposed in utero to lamotrigine monotherapy during the first trimester and born from epileptic mothers.
3 / 2514 This study is an update of Tomson's 2011 publication. They excluded from the current analysis pregnancies occurring in women without epilepsy. EURAP registry: potential overlap.

Case-control studies (cohort)

Study Country
Study period
Case Control Sample size Rmk

master protocol