Vigabatrin (Epilepsy)

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
Battino 2024	Worldwide (47 countries) 1999 - 2022 prospective cohort	The International Registry of Antiepileptic Drugs and Pregnancy (EURAP).	Pregnant women with epilepsy exposed to Vigabatrin 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	5 / 3584	Overlapping/Update: Battino 2024 (1999-2022) updates and totally includes Tomson 2018 (1999-2016) and Tomson 2011 (1 center in Spain 2000-2018) => Use of Battino 2024 for the 8 (plus 16 in eSupp) ASM monotherapies studied.
Battino 2024	Worldwide (47 countries) 1999 - 2022 prospective cohort		Reporting physicians collected information on drug therapy after each trimester.		early pregnancy	5 / 3584
Christensen (Vigabatrin) (Epilepsy) (Controls exposed to LTG) 2024	Denmark, Finland, Iceland, Norway, and Sweden 1996 - 2017 population based cohort retrospective	Nordic population-based cohort study including register data from Denmark, Finland, Iceland, Norway, and Sweden–the SCAN-AED project.	Children of mothers with epilepsy who had redeemed at least one prescription of Vigabatrin monotherapy from 30 days before the first day of the last menstrual period to the date of birth (i.e., the exposure period).	exposed to other treatment, sick Children of mothers who had redeemed at least one prescription of Lamotrigine monotherapy from 30 days before the first day of the last menstrual period to the date of birth (i.e., the exposure period).	during pregnancy (anytime or not specified)	9 / 5299	Denmark (1997–2017), Finland (1996–2016), Iceland (2004–2017), Norway (2005–2017), and Sweden (2006–2017).
			Prenatal exposure was identified via national prescription registers. These registers contain the Anatomical Therapeutic Chemical (ATC) classification code (www.whocc.no) and the date of dispensing.		during pregnancy (anytime or not specified)	9 / 5299
Christensen (Vigabatrin) (Epilepsy) (Controls unexposed, general population) 2024	Denmark, Finland, Iceland, Norway, and Sweden 1996 - 2017 population based cohort retrospective	Nordic population-based cohort study including register data from Denmark, Finland, Iceland, Norway, and Sweden–the SCAN-AED project.	Children of mothers with epilepsy who had redeemed at least one prescription of Vigabatrin monotherapy from 30 days before the first day of the last menstrual period to the date of birth (i.e., the exposure period).	unexposed, sick Children of mothers with epilepsy who had not redeemed prescription of anti-seizure medication.	during pregnancy (anytime or not specified)	9 / 22227	Denmark (1997–2017), Finland (1996–2016), Iceland (2004–2017), Norway (2005–2017), and Sweden (2006–2017).
			Prenatal exposure was identified via national prescription registers. These registers contain the Anatomical Therapeutic Chemical (ATC) classification code (www.whocc.no) and the date of dispensing.		during pregnancy (anytime or not specified)	9 / 22227
Mawer (Vigabatrin) (Controls exposed to Lamotrigine, sick) 2010	UK 2000 - 2006 prospective cohort	11 National Health Service (NHS) hospitals within Merseyside and Greater Manchester.	Children born to mothers with epilepsy exposed to vigabatrin monotherapy in utero. (This is a subgroup of exposure among the whole exposed group considered in the study).	exposed to other treatment, sick Children born to mothers with epilepsy exposed to lamotrigine monotherapy in utero.	1st trimester	1 / 40	Period of exposure confirm by author's email.
	UK 2000 - 2006 prospective cohort		The research nurse recorded personal and medical history with forms. An epilepsy specialist confirmed antiepileptic medication. Information from the patient was supplemented from clinical records.		1st trimester	1 / 40	Period of exposure confirm by author's email.
Mawer (Vigabatrin) (Controls unexposed, disease free) 2010	UK 2000 - 2006 prospective cohort	11 National Health Service (NHS) hospitals within Merseyside and Greater Manchester.	Children born to mothers with epilepsy exposed to vigabatrin monotherapy in utero. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed, disease free Children born to mothers without epilepsy who attended the same clinic on the same day or a few days later.	1st trimester	1 / 315	Period of exposure confirm by author's email.
Mawer (Vigabatrin) (Controls unexposed, disease free) 2010	UK 2000 - 2006 prospective cohort		The research nurse recorded personal and medical history with forms. An epilepsy specialist confirmed antiepileptic medication. Information from the patient was supplemented from clinical records.		1st trimester	1 / 315	Period of exposure confirm by author's email.
Mawer (Vigabatrin) (Controls unexposed, sick) 2010	UK 2000 - 2006 prospective cohort	11 National Health Service (NHS) hospitals within Merseyside and Greater Manchester.	Children born to mothers with epilepsy exposed to vigabatrin monotherapy in utero. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed, sick Children born to women with untreated epilepsy, who took no antiepileptic drugs before or during pregnancy.	1st trimester	1 / 46	Period of exposure confirm by author's email.
Mawer (Vigabatrin) (Controls unexposed, sick) 2010	UK 2000 - 2006 prospective cohort		The research nurse recorded personal and medical history with forms. An epilepsy specialist confirmed antiepileptic medication. Information from the patient was supplemented from clinical records.		1st trimester	1 / 46	Period of exposure confirm by author's email.
Morrow (Vigabatrin) (Controls exposed to Lamotrigine, sick) 2006	UK and Ireland 1996 - 2005 prospective cohort	The UK Epilepsy and Pregnancy Register	Infants of women with epilepsy exposed to vigabatrin in monotherapy during the first trimester. (This is a subgroup of exposure among the whole exposed group considered in the study).	exposed to other treatment, sick Infants of women with epilepsy exposed to lamotrigine in monotherapy during the first trimester.	1st trimester	6 / 647	Exposure period is completed thanks to Campbell 2014 which is also a UKEPR based study.
	UK and Ireland 1996 - 2005 prospective cohort	The UK Epilepsy and Pregnancy Register	Information was collected at registration and changes of antiepileptic drugs during pregnancy were detected during the follow-up duration by sending a standardised questionnaire to the patient's general practitioner. Other health care practitioners were contacted if identified.		1st trimester	6 / 647
Morrow (Vigabatrin) (Controls unexposed, sick) 2006	UK and Ireland 1996 - 2005 prospective cohort	The UK Epilepsy and Pregnancy Register	Infants of women with epilepsy exposed to vigabatrin in monotherapy during the first trimester. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed, sick Infants of women with epilepsy and who didn't take any antiepileptic drugs during pregnancy.	1st trimester	6 / 227	Exposure period is completed thanks to Campbell 2014 which is also a UKEPR based study.
Morrow (Vigabatrin) (Controls unexposed, sick) 2006	UK and Ireland 1996 - 2005 prospective cohort	The UK Epilepsy and Pregnancy Register	Information was collected at registration and changes of antiepileptic drugs during pregnancy were detected during the follow-up duration by sending a standardised questionnaire to the patient's general practitioner. Other health care practitioners were contacted if identified.		1st trimester	6 / 227
Vajda (Vigabatrin) (Controls exposed to Lamotrigine, sick) 2019	Australia 1999 - 2018 prospective cohort	The Australian Register of Antiepileptic Drugs in Pregnancy.	Offsprings born from women nearly always with epilepsy exposed to vigabatrin in monotherapy in at least the first trimester of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study).	exposed to other treatment, sick Offsprings born from women nearly always with epilepsy exposed to lamotrigine in monotherapy in at least the first trimester of pregnancy.	at least 1st trimester	1 / 406	Women with epilepsy accounted for 98.3%. Completely overlap Vajda 2013 and 2014. Study design partly completed with Vajda 2013.
	Australia 1999 - 2018 prospective cohort		Details are obtained by four in-depth telephone interviews with the women. Details provided by the participants are confirmed, as far as possible, by the treating medical practitioners and through hospital records.		at least 1st trimester	1 / 406
Vajda (Vigabatrin) (Controls unexposed, sick) 2019	Australia 1999 - 2018 prospective cohort	The Australian Register of Antiepileptic Drugs in Pregnancy.	Offsprings born from women nearly always with epilepsy exposed to vigabatrin in monotherapy in at least the first trimester of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed, sick Offsprings born from women nearly always with epilepsy not treated with antiepileptic drugs in at least the first half of pregnancy.	at least 1st trimester	1 / 176	Women with epilepsy accounted for 98.3%. Completely overlap Vajda 2013 and 2014. Study design partly completed with Vajda 2013.
Vajda (Vigabatrin) (Controls unexposed, sick) 2019	Australia 1999 - 2018 prospective cohort		Details are obtained by four in-depth telephone interviews with the women. Details provided by the participants are confirmed, as far as possible, by the treating medical practitioners and through hospital records.		at least 1st trimester	1 / 176

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