Gabapentin (Epilepsy)

Exposed non-exposed studies (cohort)

Study	Country Study period	Population source	Exposure definition	Non-exposure definition	Sample size	Rmk
Arkilo (Gabapentin), 2015	USA 2006 - 2011	Women with epilepsy who were pregnant between the study period and exposed to monotherapy antiepileptic medication at any point during the pregnancy.	Singleton whose epileptic mothers were exposed to gabapentin monotherapy at any point during the pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study).	exposed to other treatment, sick Singleton whose epileptic mothers were exposed to lamotrigine monotherapy at any point during the pregnancy.	1 / 24
Battino, 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 Gabapentin monotherapy at the time of conception.	exposed to other treatment, sick Pregnant women with epilepsy exposed to lamotrigine monotherapy at the time of conception.	37 / 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.
Bromley (Gabapentin), 2016	UK 2004 - 2007	Pregnant women with epilepsy, whether or not they were taking an antiepileptic drug in monotherapy and whose infant had been a live birth between the study period.	Children whose epileptic mothers were exposed to gabapentin monotherapy during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed, sick Children whose epileptic mothers were untreated by antiepileptic drugs during their pregnancy.	14 / 55	Design parts of this study were completed thanks to Morrow 2006. Families were not invited to participate if their child had a genetic condition associated with neurodevelopmental impairment.
Christensen (Gabapentin) (Epilepsy) (Controls exposed to LTG), 2024	Denmark, Finland, Iceland, Norway, and Sweden 1996 - 2017	All live-born singletons born of women with epilepsy in the included countries during the study periods.	Children of mothers with epilepsy who had redeemed at least one prescription of Gabapentin 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).	138 / 5299	Denmark (1997–2017), Finland (1996–2016), Iceland (2004–2017), Norway (2005–2017), and Sweden (2006–2017).
Christensen (Gabapentin) (Epilepsy) (Controls unexposed, general population), 2024	Denmark, Finland, Iceland, Norway, and Sweden 1996 - 2017	All live-born singletons born of women with epilepsy in the included countries during the study periods.	Children of mothers with epilepsy who had redeemed at least one prescription of Gabapentin 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.	138 / 22227	Denmark (1997–2017), Finland (1996–2016), Iceland (2004–2017), Norway (2005–2017), and Sweden (2006–2017).
Dean (Gabapentin), 2002	Scotland 1976 - 2000	Children of mothers taking antiepileptic drugs in pregnancy during the study period were ascertained from hospital obstetric records.	Children whose mothers took gabapentin monotherapy in pregnancy and continued beyond the first trimester. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed, sick Sibs of exposed cases not exposed to antiepileptic drugs in utero. Either the mothers had epilepsy or the child was born before epilepsy developed.	1 / 38	The data for major congenital malformations include all pregnancies surviving into the second trimester, whereas frequencies for other features were based on livebirths only. The vast majority of the mothers were treated for epilepsy.
Dreier (Controls exposed to LTG), 2023	Denmark, Finland, Iceland, Norway, and Sweden. 1996 - 2017	Live-born singleton children of mothers with epilepsy in Denmark (1997-2017), Finland (1996- 2016), Iceland (2004-2017), Norway (2005-2017), and Sweden (2006-2017).	Children prenatally exposed to Gabapentin monotherapy, i.e whose mother had redeemed 1 or more prescriptions during the exposure window, which was defined as 30 days before the first day of the last menstrual period (estimated using gestational age in days at birth) until the date of birth.	exposed to other treatment, sick Children prenatally exposed to lamotrigine monotherapy, i.e whose mother had redeemed 1 or more prescriptions during the exposure window, which was defined as 30 days before the first day of the last menstrual period (estimated using gestational age in days at birth) until the date of birth.	138 / 5288
Dreier (Controls unexposed, sick), 2023	Denmark, Finland, Iceland, Norway, and Sweden. 1996 - 2017	Live-born singleton children of mothers with epilepsy in Denmark (1997-2017), Finland (1996- 2016), Iceland (2004-2017), Norway (2005-2017), and Sweden (2006-2017).	Children prenatally exposed to gabapentin monotherapy, i.e whose mother had redeemed 1 or more prescriptions during the exposure window, which was defined as 30 days before the first day of the last menstrual period (estimated using gestational age in days at birth) until the date of birth.	unexposed, sick Children not prenatally exposed to antiseizure medication.	138 / 22203
Madley-Dowd_SE (Gabapentin) (Controls exposed to LTG), 2024	Sweden 1995 - 2020	All liveborn children born between July 1, 1995, and December 31, 2020.	Fetal exposure to Gabapentin monotherapy for epilepsy indication at any time during the pregnancy period, i.e any pregnancy with self-reported consumption during pregnancy or a prescription 30 days before pregnancy or during pregnancy.	exposed to other treatment, sick Fetal exposure to Lamotrigine monotherapy for epilepsy indication at any time during the pregnancy period, i.e any pregnancy with self-reported consumption during pregnancy or a prescription 30 days before pregnancy or during pregnancy.	43 / 2383	Data extracted from the e-Supp pdf (Table S10).
Madley-Dowd_SE (Gabapentin) (Controls exposed to LTG), 2024	Sweden 1995 - 2020	All liveborn children born between July 1, 1995, and December 31, 2020.	Fetal exposure to Gabapentin monotherapy for epilepsy indication at any time during the pregnancy period, i.e any pregnancy with self-reported consumption during pregnancy or a prescription 30 days before pregnancy or during pregnancy.	exposed to other treatment, sick Fetal exposure to Lamotrigine monotherapy for epilepsy indication at any time during the pregnancy period, i.e any pregnancy with self-reported consumption during pregnancy or a prescription 30 days before pregnancy or during pregnancy.	43 / 2383	Data extracted from the e-Supp pdf (Table S10).
Madley-Dowd_SE (Gabapentin) (Controls unexposed, sick), 2024	Sweden 1995 - 2020	All liveborn children born between July 1, 1995, and December 31, 2020.	Fetal exposure to Gabapentin monotherapy for epilepsy indication at any time during the pregnancy period, i.e any pregnancy with self-reported consumption during pregnancy or a prescription 30 days before pregnancy or during pregnancy.	unexposed, sick No fetal exposure to antiseizure medication at any time during the pregnancy period, restricted for epilepsy indication.	43 / 10769	Data extracted from the excel file (Tab Fig S12) and the e-Supp pdf (Table S10).
Madley-Dowd_SE (Gabapentin) (Controls unexposed, sick), 2024	Sweden 1995 - 2020	All liveborn children born between July 1, 1995, and December 31, 2020.	Fetal exposure to Gabapentin monotherapy for epilepsy indication at any time during the pregnancy period, i.e any pregnancy with self-reported consumption during pregnancy or a prescription 30 days before pregnancy or during pregnancy.	unexposed, sick No fetal exposure to antiseizure medication at any time during the pregnancy period, restricted for epilepsy indication.	43 / 10769	Data extracted from the excel file (Tab Fig S12) and the e-Supp pdf (Table S10).
Madley-Dowd_UK (Gabapentin) (Controls exposed to LTG) (Epilepsy), 2024	United Kingdom 1995 - 2018	All liveborn children of women aged 11–49 years in the Clinical Practice Research Datalink (CPRD) Pregnancy Register born between January 1, 1995, and December 31, 2018.	Fetal exposure to Gabapentin monotherapy for epilepsy indication at any time during the pregnancy period, i.e any pregnancy with a prescription that started or ended during the pregnancy period.	exposed to other treatment, sick Fetal exposure to Lamotrigine monotherapy for epilepsy indication at any time during the pregnancy period, i.e any pregnancy with a prescription that started or ended during the pregnancy period.	18 / 791	Partial overlapping of swedish data with Bjork 2022 and Dreier 2023 (IQ, ASD, ADHD) => these studies were kept and tagged. => Data extracted from the e-Supp pdf (Table S10).
Madley-Dowd_UK (Gabapentin) (Controls unexposed, sick) (Epilepsy), 2024	United Kingdom 1995 - 2018	All liveborn children of women aged 11–49 years in the Clinical Practice Research Datalink (CPRD) Pregnancy Register born between January 1, 1995, and December 31, 2018.	Fetal exposure to Gabapentin monotherapy for epilepsy indication at any time during the pregnancy period, i.e any pregnancy with a prescription that started or ended during the pregnancy period.	unexposed, sick No fetal exposure to antiseizure medication at any time during the pregnancy period, restricted for epilepsy indication.	18 / 4075	Partial overlapping of swedish data with Bjork 2022 and Dreier 2023 (IQ, ASD, ADHD) => these studies were kept and tagged. => Data extracted from the excel file (Tab Fig S12) and the e-Supp pdf (Table S10).
Mawer (Gabapentin) (Controls exposed to Lamotrigine, sick), 2010	UK 2000 - 2006	Midwives in the antenatal clinics approached each woman, who gave a history of epilepsy (n=231), whatever her stage of gestation.	Children born to mothers with epilepsy exposed to gabapentin 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.	2 / 40	Kini's 2007 malformation results are completely overlapped by this study (largest exposed population, longer study period). Period of exposure confirm by author's email.
Mawer (Gabapentin) (Controls unexposed, disease free), 2010	UK 2000 - 2006	Women with epilepsy (WWE) and the healthy woman controls attending the same clinic.	Children born to mothers with epilepsy exposed to gabapentin 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.	2 / 315	Kini's 2007 malformation results are completely overlapped by this study (largest exposed population, longer study period). Period of exposure confirm by author's email.
Mawer (Gabapentin) (Controls unexposed, sick), 2010	UK 2000 - 2006	Midwives in the antenatal clinics approached each woman, who gave a history of epilepsy (n=231), whatever her stage of gestation.	Children born to mothers with epilepsy exposed to gabapentin 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.	2 / 46	Kini's 2007 malformation results are completely overlapped by this study (largest exposed population, longer study period). Period of exposure confirm by author's email.
Miškov (Gabapentin) (Controls exposed to Lamotrigine, sick), 2016	Croatia 2003 - 2013	Pregnant women with epilepsy during the study period at the the Sestre milosrdnice University Hospital Center.	Pregnancies in women with epilepsy on gabapentin monotherapy. (This is a subgroup of exposure among the whole exposed group considered in the study).	exposed to other treatment, sick Pregnancies in women with epilepsy on lamotrigine monotherapy.	2 / 37	Includes all Miskov's 2010 outcomes.
Miškov (Gabapentin) (Controls unexposed, disease free), 2016	Croatia 2003 - 2013	Pregnant women with epilepsy during the study period at the the Sestre milosrdnice University Hospital Center.	Pregnancies in women with epilepsy on gabapentin monotherapy. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed, disease free Pregnancies in healthy controls.	2 / 147	Includes all Miskov's 2010 outcomes.
Miškov (Gabapentin) (Controls unexposed, sick), 2016	Croatia 2003 - 2013	Pregnant women with epilepsy during the study period at the the Sestre milosrdnice University Hospital Center.	Pregnancies in women with epilepsy on gabapentin monotherapy. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed, sick Pregnancies in women with epilepsy without antiepileptic drugs.	2 / 4	Includes all Miskov's 2010 outcomes.
Morrow (Gabapentin) (Controls exposed to Lamotrigine, sick), 2006	UK and Ireland 1996 - 2005	Pregnant women with epilepsy, whether or not they were taking an AED, either in monotherapy or polytherapy, and who were referred to the register before the outcome of the pregnancy was known.	Infants of women with epilepsy exposed to gabapentin 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.	31 / 647	Exposure period is completed thanks to Campbell 2014 which is also a UKEPR based study.
Morrow (Gabapentin) (Controls unexposed, sick), 2006	UK and Ireland 1996 - 2005	Pregnant women with epilepsy, whether or not they were taking an antiepileptic drug, either in monotherapy or polytherapy, and who were referred to the register before the outcome of the pregnancy was known.	Infants of women with epilepsy exposed to gabapentin 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.	31 / 227	Exposure period is completed thanks to Campbell 2014 which is also a UKEPR based study.
Razaz (Gabapentin), 2024	Denmark, Finland, Iceland, Norway and Sweden. 1996 - 2017	All singleton births at 22 or more completed gestational weeks in the 5 Nordic countries during the different study periods.	Mothers with epilepsy who filled a prescription for Gabapentin monotherapy between the date of the last menstrual period (LMP) and the day of birth.	unexposed, sick Mothers with epilepsy who did not fill an antiseizure medication (ASM) prescription in the period between 90 days before the last menstrual period (LMP) and the day of birth.	108 / 19043
Vajda (Gabapentin) (Controls exposed to Lamotrigine, sick), 2018	Australia 1999 - 2016	Pregnant women whether treated with antiepileptic drugs or left untreated in at least the first half of pregnancy.	Offsprings of pregnant women with epilepsy exposed to gabapentin in monotherapy throughout. (This is a subgroup of exposure among the whole exposed group considered in the study).	exposed to other treatment, sick Offsprings of pregnant women with epilepsy exposed to lamotrigine in monotherapy throughout.	14 / 382
Vajda (Gabapentin) (Controls exposed to Lamotrigine, sick), 2013	Australia 1999 - 2013	Pregnant women with epilepsy whether treated with antiepileptic drugs or left untreated or pregnant women taking antiepileptic drugs for other purposes.	Offsprings from women with epilepsy exposed to gabapentin 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 from women with epilepsy exposed to lamotrigine in monotherapy in at least the first trimester of pregnancy.	14 / 315	Women taking AED for epilepsy are in majority (more than 90%). Vajda 2007; 2010 (x2) and 2014 malformations results are already included in Vajda 2013.
Vajda (Gabapentin) (Controls unexposed, sick), 2018	Australia 1999 - 2016	Pregnant women whether treated with antiepileptic drugs or left untreated in at least the first half of pregnancy.	Offsprings of pregnant women with epilepsy exposed to gabapentin in monotherapy throughout. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed, sick Offsprings of pregnant women with epilepsy that have been untreated in at least the first half of pregnancy.	14 / 170
Vajda (Gabapentin) (Controls unexposed, sick), 2013	Australia 1999 - 2013	Pregnant women with epilepsy whether treated with antiepileptic drugs or left untreated or pregnant women taking antiepileptic drugs for other purposes.	Offsprings from women with epilepsy exposed to gabapentin 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 from women with epilepsy not exposed to antiepileptic drugs in at least the first trimester of pregnancy.	14 / 147	Women taking AED for epilepsy are in majority (more than 90%). Vajda 2007; 2010 (x2) and 2014 overlap.
Wood (Gabapentin), 2015	Australia 2007 - 2010	Women with epilepsy and their children (aged 6–8 years) exposed in utero with antiepileptic drugs were identified through the Australian Pregnancy Register for Women on Antiepileptic Medication (APR).	Children of women with epilepsy exposed to gabapentin in monotherapy during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study).	exposed to other treatment, sick Children of women with epilepsy exposed to lamotrigine in monotherapy during pregnancy.	1 / 9	Children with major birth defects or a diagnosis of epilepsy were excluded, as these conditions are known risk factors for autism spectrum disorders. Child IQ isn't specified for this monotherapy alone.

Case-control studies (cohort)

Study	Country Study period	Case	Control	Sample size	Rmk

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

1 study, not fulfilled eligibility criteria, were excluded. See excluded tab for the list of these studies and reason of exclusion.

master protocol