Felbamate (Epilepsy = All indications) - Medication and Pregnancy KB

Felbamate (Epilepsy = All indications)

Exposed non-exposed, cohort studies

Study	Country Study period Study design	Data source	Exposure definition	Non-exposure definition	Exposition period	Sample size (exposed/unexposed) Or (case / control)	Remarks	Risk of bias
Battino (Felbamate) (Epilepsy) 2024	Worldwide (47 countries) 1999 - 2022 prospective cohort	The International Registry of Antiepileptic Drugs and Pregnancy (EURAP).	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.	early pregnancy	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.
Battino (Felbamate) (Epilepsy) 2024	Worldwide (47 countries) 1999 - 2022 prospective cohort		Reporting physicians collected information on drug therapy after each trimester.		early pregnancy	3 / 3584
Katz (Felbamate) 2001	USA 1990 - 2000 retrospective cohort	Department of Neurology, New York University School of Medicine.	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.	during pregnancy (anytime or not specified)	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.
Katz (Felbamate) 2001	USA 1990 - 2000 retrospective cohort		Telephone interviews were given to the patient as a supplement to the chart analysis. Spouses were interviewed only when additional information could not be provided by the patient.		during pregnancy (anytime or not specified)	5 / 3

Case-control studies

Study	Country Study period Study design	Data source	Case	Control	Exposition	Exposition period	Sample size (exposed/unexposed) Or (case / control)	Remarks	Risk of bias

Risk of bias: : NA; : low; : moderate; : serious; : critical; : unclear;

Empty. There are no case-control studies available for this drug.

master protocol