Gabapentin (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 Risk of bias
Arkilo (Gabapentin)
2015 		USA
2006 - 2011
retrospective cohort 		Minnesota Epilepsy Group, P.A. of United Hospital and Children's Hospitals and Clinics of Minnesota 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. 		during pregnancy (anytime or not specified) 1 / 24
Questionnaires were sent to women.
Battino
2024 		Worldwide (47 countries)
1999 - 2022
prospective cohort 		The International Registry of Antiepileptic Drugs and Pregnancy (EURAP). 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. 		early pregnancy 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.
Reporting physicians collected information on drug therapy after each trimester.
Bromley (Gabapentin)
2016 		UK
2004 - 2007
retrospective cohort (registry) 		The UK Epilepsy and Pregnancy Register. 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. 		during pregnancy (anytime or not specified) 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.
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.
Christensen (Gabapentin) (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 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). 		during pregnancy (anytime or not specified) 138 / 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.
Christensen (Gabapentin) (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 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. 		during pregnancy (anytime or not specified) 138 / 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.
Dean (Gabapentin)
2002 		Scotland
1976 - 2000
retrospective cohort 		Aberdeen Maternity Hospital, the antenatal clinic and postnatal wards. 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. 		at least 1st trimester 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.
A structured interview was carried out by a trained research nurse using questionnaires.
Dreier (Controls exposed to LTG)
2023 		Denmark, Finland, Iceland, Norway, and Sweden.
1996 - 2017
population based cohort propective 		A prospective, population-based register study within the SCAN-AED project, based on children born in Denmark, Finland, Iceland, Norway, and Sweden. 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. 		during pregnancy (anytime or not specified) 138 / 5288
Information on use of antiseizure medications was based on the national prescription registers, which contain information on all reimbursed prescription medications dispensed at pharmacies in each country, including date of dispensing and Anatomical Therapeutic Chemical (ATC) classification code.
Dreier (Controls unexposed, sick)
2023 		Denmark, Finland, Iceland, Norway, and Sweden.
1996 - 2017
population based cohort propective 		A prospective, population-based register study within the SCAN-AED project, based on children born in Denmark, Finland, Iceland, Norway, and Sweden. 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. 		during pregnancy (anytime or not specified) 138 / 22203
Information on use of antiseizure medications was based on the national prescription registers, which contain information on all reimbursed prescription medications dispensed at pharmacies in each country, including date of dispensing and Anatomical Therapeutic Chemical (ATC) classification code.
Madley-Dowd_SE (Gabapentin) (Controls exposed to LTG)
2024 		Sweden
1995 - 2020
population based cohort retrospective 		The Swedish Developmental Origins of Health and Disease (DOHaD) cohort, which is a registry study linking several national electronic data sources. 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. 		during pregnancy (anytime or not specified) 43 / 2383 Data extracted from the e-Supp pdf (Table S10).
Self-reported maternal consumption of antiseizure medications were prospectively recorded at antenatal care visits (from a structured interview at the first visit at 8–10 weeks of gestation, supplemented from 2005 with drug all prescription dispensations in Sweden (tetrachoric correlation 0.98).
Madley-Dowd_SE (Gabapentin) (Controls exposed to LTG)
2024 		Sweden
1995 - 2020
population based cohort retrospective 		The Swedish Developmental Origins of Health and Disease (DOHaD) cohort, which is a registry study linking several national electronic data sources. 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. 		during pregnancy (anytime or not specified) 43 / 2383 Data extracted from the e-Supp pdf (Table S10).
Self-reported maternal consumption of antiseizure medications were prospectively recorded at antenatal care visits (from a structured interview at the first visit at 8–10 weeks of gestation, supplemented from 2005 with drug all prescription dispensations in Sweden (tetrachoric correlation 0.98).
Madley-Dowd_SE (Gabapentin) (Controls unexposed, sick)
2024 		Sweden
1995 - 2020
population based cohort retrospective 		The Swedish Developmental Origins of Health and Disease (DOHaD) cohort, which is a registry study linking several national electronic data sources. 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. 		during pregnancy (anytime or not specified) 43 / 10769 Data extracted from the excel file (Tab Fig S12) and the e-Supp pdf (Table S10).
Self-reported maternal consumption of antiseizure medications were prospectively recorded at antenatal care visits (from a structured interview at the first visit at 8–10 weeks of gestation, supplemented from 2005 with drug all prescription dispensations in Sweden (tetrachoric correlation 0.98).
Madley-Dowd_SE (Gabapentin) (Controls unexposed, sick)
2024 		Sweden
1995 - 2020
population based cohort retrospective 		The Swedish Developmental Origins of Health and Disease (DOHaD) cohort, which is a registry study linking several national electronic data sources. 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. 		during pregnancy (anytime or not specified) 43 / 10769 Data extracted from the excel file (Tab Fig S12) and the e-Supp pdf (Table S10).
Self-reported maternal consumption of antiseizure medications were prospectively recorded at antenatal care visits (from a structured interview at the first visit at 8–10 weeks of gestation, supplemented from 2005 with drug all prescription dispensations in Sweden (tetrachoric correlation 0.98).
Madley-Dowd_UK (Gabapentin) (Controls exposed to LTG) (Epilepsy)
2024 		United Kingdom
1995 - 2018
retrospective cohort (claims database) 		The UK primary care-based Clinical Practice Research Datalink (CPRD) GOLD, with linkage to the CPRD Pregnancy Register, the CPRD Mother-Baby link, the Hospital Episode Statistics (HES) database, ... 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. 		during pregnancy (anytime or not specified) 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).
Prescriptions were identified from primary care records.
Madley-Dowd_UK (Gabapentin) (Controls unexposed, sick) (Epilepsy)
2024 		United Kingdom
1995 - 2018
retrospective cohort (claims database) 		The UK primary care-based Clinical Practice Research Datalink (CPRD) GOLD, with linkage to the CPRD Pregnancy Register, the CPRD Mother-Baby link, the Hospital Episode Statistics (HES) database, ... 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. 		during pregnancy (anytime or not specified) 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).
Prescriptions were identified from primary care records.
Mawer (Gabapentin) (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 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. 		1st trimester 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.
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.
Mawer (Gabapentin) (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 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. 		1st trimester 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.
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.
Mawer (Gabapentin) (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 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. 		1st trimester 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.
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.
Miškov (Gabapentin) (Controls exposed to Lamotrigine, sick)
2016 		Croatia
2003 - 2013
prospective cohort 		The Sestre milosrdnice University Hospital Center in Zagreb 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. 		during pregnancy (anytime or not specified) 2 / 37 Includes all Miskov's 2010 outcomes.
Data collected on pregnant women during outpatient visits to the neurologist, gynecologist and pediatrician neurologist.
Miškov (Gabapentin) (Controls unexposed, disease free)
2016 		Croatia
2003 - 2013
prospective cohort 		The Sestre milosrdnice University Hospital Center in Zagreb 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. 		during pregnancy (anytime or not specified) 2 / 147 Includes all Miskov's 2010 outcomes.
Data collected on pregnant women during outpatient visits to the neurologist, gynecologist and pediatrician neurologist.
Miškov (Gabapentin) (Controls unexposed, sick)
2016 		Croatia
2003 - 2013
prospective cohort 		The Sestre milosrdnice University Hospital Center in Zagreb 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. 		during pregnancy (anytime or not specified) 2 / 4 Includes all Miskov's 2010 outcomes.
Data collected on pregnant women during outpatient visits to the neurologist, gynecologist and pediatrician neurologist.
Morrow (Gabapentin) (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 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. 		1st trimester 31 / 647 Exposure period is completed thanks to Campbell 2014 which is also a UKEPR based study.
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.
Morrow (Gabapentin) (Controls unexposed, sick)
2006 		UK and Ireland
1996 - 2005
prospective cohort 		The UK Epilepsy and Pregnancy Register 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. 		1st trimester 31 / 227 Exposure period is completed thanks to Campbell 2014 which is also a UKEPR based study.
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.
Razaz (Gabapentin)
2024 		Denmark, Finland, Iceland, Norway and Sweden.
1996 - 2017
population based cohort retrospective 		The SCAN-AED project, using the Nordic register infrastructures. 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. 		during pregnancy (anytime or not specified) 108 / 19043
Prescription for antiseizure medication (ASM) was ascertained using nationwide prescription registers and identified ASMs based on Anatomical Therapeutic Chemical Classification.
Vajda (Gabapentin) (Controls exposed to Lamotrigine, sick)
2013 		Australia
1999 - 2013
prospective cohort 		The Australian Register of Antiepileptic Drugs in Pregnancy. 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. 		at least 1st trimester 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.
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.
Vajda (Gabapentin) (Controls exposed to Lamotrigine, sick)
2018 		Australia
1999 - 2016
prospective cohort 		The Australian Register of Antiepileptic Drugs in 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. 		throughout pregnancy 14 / 382
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.
Vajda (Gabapentin) (Controls unexposed, sick)
2018 		Australia
1999 - 2016
prospective cohort 		The Australian Register of Antiepileptic Drugs in 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. 		throughout pregnancy 14 / 170
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.
Vajda (Gabapentin) (Controls unexposed, sick)
2013 		Australia
1999 - 2013
prospective cohort 		The Australian Register of Antiepileptic Drugs in Pregnancy. 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. 		at least 1st trimester 14 / 147 Women taking AED for epilepsy are in majority (more than 90%). Vajda 2007; 2010 (x2) and 2014 overlap.
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.
Wood (Gabapentin)
2015 		Australia
2007 - 2010
prospective cohort 		The Australian Pregnancy Register (APR) for Women on Antiepileptic Medication. 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. 		during pregnancy (anytime or not specified) 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.
Details are obtained by four in-depth telephone interviews with the women. And treating doctors are contacted to confirm medical details.

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.

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