Felbamate (Epilepsy = All indications)

Exposed non-exposed studies (cohort)

Study Country
Study period
Population source Exposure definition Non-exposure definition Sample size Rmk
Battino (Felbamate) (Epilepsy), 2024 Worldwide (47 countries)
1999 - 2022
Pregnant women with epilepsy exposed to antiseizure medications at the time of conception and enrolled within the 16th week of gestation, where fetal outcome had not yet been determined. Pregnant women with epilepsy exposed to Felbamate monotherapy at the time of conception. exposed to other treatment, sick
Pregnant women with epilepsy exposed to lamotrigine monotherapy at the time of conception.
3 / 3584 Overlapping/Update: Battino 2024 (1999-2022) updates and totally includes Tomson 2018 (1999-2016), Tomson 2011 and Jimenez 2020 (1 center in Spain 2000-2018) => Use of Battino 2024 for the 8 (plus 16 in eSupp) monotherapies studied.
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.

Case-control studies (cohort)

Study Country
Study period
Case Control Sample size Rmk

master protocol