Pregabalin (All indications)

Exposed non-exposed studies (cohort)

Study	Country Study period	Population source	Exposure definition	Non-exposure definition	Sample size	Rmk
Bjørk (Controls exposed to Lamotrigine, sick) (Other indications), 2022	Danemark, Finland, Iceland, Norway and Sweden. 1996 - 2017	Singleton births born from mothers from five Nordic countries.	Pregnacies in mothers filling at least one pregabalin monotherapy prescription from her last menstrual period until birth. (This is a subgroup of exposure among the whole exposed group considered in the study).	exposed to other treatment, sick Pregnacies in mothers filling at least one lamotrigine monotherapy prescription from her last menstrual period until birth.	1666 / 7950	Excluded twins and triplets for statistical reasons and children with chromosomal disorders diagnosed before end of follow-up.
Bjørk (Controls unexposed NOS) (Other indications), 2022	Danemark, Finland, Iceland, Norway and Sweden. 1996 - 2017	Singleton births born from mothers from five Nordic countries.	Pregnacies in mothers filling at least one pregabalin monotherapy prescription from her last menstrual period until birth. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed (general population or NOS) Pregnacies in mothers without antiseizure medication prescription from her last menstrual period until birth.	1666 / 4463879	Excluded twins and triplets for statistical reasons and children with chromosomal disorders diagnosed before end of follow-up.
Bjørk (Controls unexposed, sick) (Other indications), 2022	Danemark, Finland, Iceland, Norway and Sweden. 1996 - 2017	Singleton births born from mothers from five Nordic countries.	Pregnacies in mothers filling at least one pregabalin monotherapy prescription from her last menstrual period until birth. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed, sick Pregnacies in epileptic mothers without antiseizure medication prescription from her last menstrual period until birth.	1666 / 21634	Excluded twins and triplets for statistical reasons and children with chromosomal disorders diagnosed before end of follow-up.
Blotière (Controls exposed to Lamotrigine, sick) (Other indications), 2019	France 2011 - 2015	All pregnancies ending between the study period with at least 20 weeks of gestation	Pregnancies exposed to pregabalin monotherapy between 1 month before and 2 months after the beginning of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study).	exposed to other treatment, sick Pregnancies exposed to lamotrigine monotherapy between 1 month before and 2 months after the beginning of pregnancy.	1671 / 2997	Authors excluded twin pregnancies and pregnancies with a chromosomal abnormality identified. Less than 90% of exposed pregnancies have a proxy for epilepsy. Publication's OR were not kept when lower limit of the confidence interval or OR equal to 0.
Blotière (Controls unexposed NOS) (Other indications), 2019	France 2011 - 2015	All pregnancies ending between the study period with at least 20 weeks of gestation	Pregnancies exposed to pregabalin monotherapy between 1 month before and 2 months after the beginning of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed (general population or NOS) Pregnancies with no reimbursement for antiepileptic drugs.	1671 / 1875733	Authors excluded twin pregnancies and pregnancies with a chromosomal abnormality identified. Less than 10% of exposed pregnancies have a proxy for epilepsy. Publication's OR were not kept when lower limit of the confidence interval or OR equal to 0.
Coste (Controls exposed to Lamotrigine, sick) (Mixed indications), 2020	France 2011 - 2014	All liveborn singleton children born during the study period. The mother had to be covered by the national health insurance general scheme for salaried workers and to have had at least one health expenditure reimbursement over the 2 years preceding the onset of pregnancy.	Children born from mothers exposed to pregabalin monotherapy indicated for the treatment of epilepsy and migraine with at least one dispensing between the month preceding onset of pregnancy and its end. (This is a subgroup of exposure among the whole exposed group considered in the study).	exposed to other treatment, sick Children born from mothers exposed to lamotrigine monotherapy for mixed indications during pregnancy.	1627 / 2916	Children with a diagnosis of brain malformation (ICD-10 codes Q00 to Q04 and Q05.0 to Q05.4) during their stay in the maternity unit are excluded. Results are extracted from Blotière et al. 2020 because they reported aOR for vs LTG.
Coste (Controls unexposed, NOS) (Mixed indications), 2020	France 2011 - 2014	All liveborn singleton children born during the study period. The mother had to be covered by the national health insurance general scheme for salaried workers and to have had at least one health expenditure reimbursement over the 2 years preceding the onset of pregnancy.	Children born from mothers exposed to pregabalin monotherapy indicated for the treatment of epilepsy and neuropathic pain with at least one dispensing between the month preceding onset of pregnancy and its end. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed (general population or NOS) Children born from mothers not exposed to any antiepileptic drug during pregnancy.	1627 / 1710441	Children with a diagnosis of brain malformation (ICD-10 codes Q00 to Q04 and Q05.0 to Q05.4) during their stay in the maternity unit are excluded.
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
Dudukina (Controls exposed to LTG) (Mixed indications), 2023	Denmark, Finland, Norway, and Sweden. 2005 - 2016	All pregnancies (ending in live births or stillbirths) identified in the respective administrative registries from 2005 to 2015 in Denmark, Finland, and Norway and all pregnancies identified from 2006 to 2016 in Sweden.	At least one dispensing of pregabalin monotherapy (no dispensing for any other antipileptic drug) from last menstrual period (LMP) -90 days to LMP 97 days (first trimester) or any trimester to treat epilepsy, generalized anxiety disorder (GAD), and neuropathic pain.	exposed to other treatment, sick At least one dispensing of lamotrigine monotherapy (no dispensing for any other antipileptic drug) from last menstrual period (LMP) -90 days to LMP 97 days (first trimester) or any trimester.	2332 / 7005	For ASD and Cognitive disorders: Overlapping: Dudukina 2023 included in Bjork 2022, that have a more relevant period of exposure => Use of Bjork 2022. Use of sensitivity analysis of pregabalin monotherapy.
Dudukina (Controls unexposed, NOS) (Mixed indications), 2023	Denmark, Finland, Norway, and Sweden. 2005 - 2016	All pregnancies (ending in live births or stillbirths) identified in the respective administrative registries from 2005 to 2015 in Denmark, Finland, and Norway and all pregnancies identified from 2006 to 2016 in Sweden.	At least one dispensing of pregabalin monotherapy (no dispensing for any other antiepileptic drug) from last menstrual period (LMP) -90 days to LMP 97 days (first trimester) or any trimester to treat epilepsy, generalized anxiety disorder (GAD), and neuropathic pain.	unexposed (general population or NOS) Pregnancies without dispensing for pregabalin monotherapy or other antiepileptic drugs including lamotrigine, or duloxetine during the first trimester or any trimester.	2332 / 3063173	For ASD and Cognitive disorders: Overlapping: Dudukina 2023 included in Bjork 2022, that have a more relevant period of exposure => Use of Bjork 2022. Use of sensitivity analysis of pregabalin monotherapy.
Källén (Controls exposed to Lamotrigine, sick) (Indications NOS), 2013	Swedish 1996 - 2011	Nearly all births in Sweden during the study period (1,575,847) are registered in The Swedish Medical Birth Register.	Infants whose mothers used pregabalin in monotherapy in early pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study).	exposed to other treatment, sick Infants whose mothers used lamotrigine in monotherapy in early pregnancy.	111 / 1084	Indications for antiepileptic drugs are not specified. Follow-up period known thanks to author's email reply.
Källén (Controls unexposed, NOS) (Indications NOS), 2013	Swedish 1996 - 2011	Nearly all births in Sweden during the study period (1,575,847) are registered in The Swedish Medical Birth Register.	Infants whose mothers used pregabalin in monotherapy in early pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed (general population or NOS) Infants in population whose mothers used at least one of a central nervous system active drugs (less than 3%) or weren't exposed in early pregnancy.	111 / 1575847	Indications for antiepileptic drugs are not specified. Follow-up period known thanks to author's email reply.
Kilic (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014	Denmark 1997 - 2008	All singleton live-born children in Denmark during the study period.	Children whose mothers have been exposed to pregabalin in monotherapy during the exposure window defined from 30 days before the estimated day of conception to the day prior to birth. (This is a subgroup of exposure among the whole exposed group considered in the study).	exposed to other treatment, sick Children whose mothers have been exposed to lamotrigine in monotherapy during the exposure window defined from 30 days before the estimated day of conception to the day prior to birth.	13 / 880	Less than 90% of women are epileptic.
Kilic (Controls unexposed NOS) (Mixed indications), 2014	Denmark 1997 - 2008	All singleton live-born children in Denmark during the study period.	Children whose mothers have been exposed to pregabalin in monotherapy during the exposure window defined from 30 days before the estimated day of conception to the day prior to birth. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed (general population or NOS) Children whose mothers haven't been exposed to antiepileptic drugs 30 days before the estimated day of conception to the day of birth.	13 / 676834	Less than 90% of women are epileptic.
Kilic (Controls unexposed, sick) (Mixed indications), 2014	Denmark 1997 - 2008	All singleton live-born children in Denmark during the study period.	Children whose mothers have been exposed to pregabalin in monotherapy during the exposure window defined from 30 days before the estimated day of conception to the day prior to birth. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed, sick Children whose mothers have an epilepsy diagnosis and haven't been exposed to antiepileptic drugs 30 days before the estimated day of conception to the day of birth.	13 / 5296	Less than 90% of women are epileptic.
Patorno_MAX and MaketScan (Other indications), 2017	USA 2000 - 2010	All pregnancies in women 12 to 55 years of age that resulted in a live-born infant between the study period for Medicaid beneficiaries. They have continuous Medicaid eligibility from 90 days before the estimated last menstrual period until 1 month after delivery. And commercially insured patients in Marketscan.	Infants born to women exposed to pregabalin (at least one filled prescription during the first trimester of pregnancy) but not to other anticonvulsant drugs during the 3 months before the start of pregnancy or during the first trimester.	unexposed (general population or NOS) Infants born to women who had no dispensings for pregabalin or other anticonvulsant medications during the 3 months before the start of pregnancy or during the first trimester.	471 / 1322955	Reported results are pooled OR of 1st trimester monotherapy of the 2 cohorts (MAX and Market scan). Less than 10% of women have epilepsy. Study design partly completed with cited source [5].
The NAAED (Controls exposed to LTG) (Indications NOS), 2024	North America and Canada 1997 - 2022	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 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 who used lamotrigine as monotherapy, during the first trimester.	62 / 2461	Study design completed with the publication of Hernández-Díaz et al. 2012. Data extracted from the North American AED pregnancy registry website. Indications not specified.
The NAAED (Controls unexposed, disease free) (Indications NOS), 2024	North America and Canada 1997 - 2022	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 who used Pregabalin as monotherapy, during the first trimester. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed, disease free Infants of pregnant women, not taking an antiepileptic drug and without epilepsy, who were recruited from among the friends and family members of the enrolled women taking an antiepileptic drug.	62 / 1311	Study design completed with Hernández-Díaz et al., 2012. Data extracted from the NAAED registry website. Internal control group reported rather than the external (for relevance purpose). Indications not specified. Wyszynski et al., 2005 overlapped.
Tomson, 2018	42 countries 1999 - 2016	Pregnancies registered in the database during the study period who had been exposed to antiepileptic drug monotherapy and had complete follow-up data up to 1 year. They were enrolled within gestation week 16 and before fetal outcome is known.	Offspring exposed in utero to pregabalin monotherapy during the first trimester and born from epileptic mothers. (This is a subgroup of exposure among the whole exposed group considered in the study).	exposed to other treatment, sick Offspring exposed in utero to lamotrigine monotherapy during the first trimester and born from epileptic mothers.	4 / 2514	This study is an update of Tomson's 2011 publication. They excluded from the current analysis pregnancies occurring in women without epilepsy. EURAP registry: potential overlap.
Vajda (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. Malformations results presented in Jazayeri 2018 are already included in this publication.
Vajda (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. Malformations results presented in Jazayeri 2018 are already included in this publication.
Veiby (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014	Norway 1999 - 2011	777,785 deliveries recorded in the database during the study period.	Children exposed prenatally to pregabalin as monotherapy indicated for their mothers' epilepsy or other indications. (This is a subgroup of exposure among the whole exposed group considered in the study).	exposed to other treatment, sick Children exposed prenatally to lamotrigine as monotherapy indicated for their mothers' epilepsy or other indications.	30 / 833	Less than 90% of women are treated with Lamotrigine for epilepsy and indications for Pregabalin is unknown.
Veiby (Controls unexposed, disease free) (Mixed indications), 2014	Norway 1999 - 2011	777,785 deliveries recorded in the database during the study period.	Children exposed prenatally to pregabalin as monotherapy indicated for their mothers' epilepsy or other indications. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed, disease free All unexposed children born to women without epilepsy.	30 / 771412	Indications for Pregabalin is unknown.
Veiby (Controls unexposed, sick) (Mixed indications), 2014	Norway 1999 - 2011	777,785 deliveries recorded in the database during the study period.	Children exposed prenatally to pregabalin as monotherapy indicated for their mothers' epilepsy or other indications. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed, sick Children born to women with a history of epilepsy but no antiepileptic drug treatment during pregnancy.	30 / 3773	Indications for Pregabalin is unknown.
Winterfeld (Other indications), 2016	Worldwide (France, United Kingdom, Italy, Finland, Switzerland, the Netherlands, and Turkey) 2004 - 2013	Women who themselves or whose physician contacted one of the centers.	Pregnancies in patients with pregabalin monotherapy exposure during the first trimester of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed (general population or NOS) Pregnancies in patients who were not exposed to any medications known to be teratogenic or to any antiepileptic drugs.	19 / 656	Study design completed with cited source [14].

Case-control studies (cohort)

Study	Country Study period	Case	Control	Sample size	Rmk

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

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

master protocol