Pregabalin (Epilepsy) - Medication and Pregnancy KB

Pregabalin (Epilepsy)

Exposed non-exposed studies (cohort)

Study	Country Study period	Population source	Exposure definition	Non-exposure definition	Sample size	Rmk
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 Pregabalin monotherapy at the time of conception.	exposed to other treatment, sick Pregnant women with epilepsy exposed to lamotrigine monotherapy at the time of conception.	7 / 3584	Overlapping/Update: Battino 2024 (1999-2022) updates and totally includes Tomson 2018 (1999-2016) and Tomson 2011 => Use of Battino 2024 for the 8 (plus 16 in eSupp) ASM monotherapies studied here.
Christensen (Pregabalin) (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 Pregabalin 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).	120 / 5299	Denmark (1997–2017), Finland (1996–2016), Iceland (2004–2017), Norway (2005–2017), and Sweden (2006–2017).
Christensen (Pregabalin) (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 Pregabalin 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.	120 / 22227	Denmark (1997–2017), Finland (1996–2016), Iceland (2004–2017), Norway (2005–2017), and Sweden (2006–2017).
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 pregabalin 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.	120 / 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 pregabalin 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.	120 / 22203
Madley-Dowd_SE (Pregabalin) (Controls exposed to LTG), 2024	Sweden 1995 - 2020	All liveborn children born between July 1, 1995, and December 31, 2020.	Fetal exposure to Pregabalin 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.	45 / 2383	Data extracted from the e-Supp pdf (Table S10).
Madley-Dowd_SE (Pregabalin) (Controls unexposed, sick), 2024	Sweden 1995 - 2020	All liveborn children born between July 1, 1995, and December 31, 2020.	Fetal exposure to Pregabalin 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.	45 / 10769	Data extracted from the excel file (Tab Fig S12) and the e-Supp pdf (Table S10).
Madley-Dowd_UK (Pregabalin) (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 Pregabalin 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.	9 / 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 (Pregabalin) (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 Pregabalin 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.	9 / 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).
Moore (Pregabalin) (Epilepsy) (Controls exposed to LTG), 2025	Scotland 2010 - 2023	All singleton pregnancies (and the associated babies and resulting live births) with an estimated date of conception from 1 April 2010 until 2 July 2023.	A prescription for Pregabalin monotherapy (no other antiseizure medication), in women reported to have epilepsy, dispensed at any point from 28 days prior to the estimated date of conception up to pregnancy end date or up to 19 weeks and 6 days (19 6 weeks) gestation for (congenital conditions).	exposed to other treatment, sick A prescription for lamotrigine monotherapy (no other antiseizure medication) in women reported to have epilepsy, dispensed at any point from 28 days prior to the estimated date of conception up to pregnancy end date or up to 19 weeks and 6 days (19 6 weeks) gestation for (congenital conditions).	97 / 713
Moore (Pregabalin) (Epilepsy) (Controls unexposed, sick), 2025	Scotland 2010 - 2023	All singleton pregnancies (and the associated babies and resulting live births) with an estimated date of conception from 1 April 2010 until 2 July 2023.	A prescription for Pregabalin monotherapy (no other antiseizure medication), in women reported to have epilepsy, dispensed at any point from 28 days prior to the estimated date of conception up to pregnancy end date or up to 19 weeks and 6 days (19 6 weeks) gestation for (congenital conditions).	unexposed, sick No equivalent prescription in women reported to have epilepsy, matched on 1) gestation and 2) year of conception.	97 / 946
Razaz (Pregabalin), 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 Pregabalin 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.	89 / 19043
The NAAED (Pregabalin) (Epilepsy), 2025	North America and Canada 1997 - 2023	Pregnant women who are taking an antiepileptic drug for any reason and had a liveborn infant, a stillborn infant, or a pregnancy terminated because of a fetal abnormality and enrolled as 'pure' or 'traditional' enrollees.	Infants of pregnant women with epilepsy who used pregabalin as 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 pregnant women with epilepsy who used Lamotrigine as monotherapy, during the first trimester. (This is a subgroup of exposure among the whole exposed group considered in the study).	5 / 1944	Hernández-Díaz 2025 Table e-2.
Vajda (Pregabalin) (Controls exposed to Lamotrigine, sick), 2019	Australia 1999 - 2018	Pregnant women taking antiepileptic drugs for any indications or not treated with antiepileptic drugs in at least the first half of pregnancy.	Offsprings born from women nearly always with epilepsy exposed to pregabalin 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.	1 / 406	Women with epilepsy accounted for 98.3%. Study design partly completed with Vajda 2013.
Vajda (Pregabalin) (Controls unexposed, sick), 2019	Australia 1999 - 2018	Pregnant women taking antiepileptic drugs for any indications or not treated with antiepileptic drugs in at least the first half of pregnancy.	Offsprings born from women nearly always with epilepsy exposed to pregabalin 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.	1 / 176	Women with epilepsy accounted for 98.3%. Study design partly completed with Vajda 2013.

Case-control studies (cohort)

Study	Country Study period	Case	Control	Sample size	Rmk

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

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