Pregabalin (All indications)

Study Reference
Battino (Epilepsy), 2024

Battino Risk of Major Congenital Malformations and Exposure to Antiseizure Medication Monotherapy. JAMA Neurol 2024; 81:481-489

Tomson Comparative risk of major congenital malformations with eight different antiepileptic drugs: a prospective cohort study of the EURAP registry. Lancet Neurol 2018; 17:530-538

Tomson T Dose-dependent risk of malformations with antiepileptic drugs: an analysis of data from the EURAP epilepsy and pregnancy registry. Lancet Neurol 2011;10:609-17

Bjørk (Controls exposed to Lamotrigine, sick) (Mixed indications), 2022

Bjørk Association of Prenatal Exposure to Antiseizure Medication With Risk of Autism and Intellectual Disability. JAMA Neurol 2022; :

Bjørk (Controls unexposed NOS) (Mixed indications), 2022

Bjørk Association of Prenatal Exposure to Antiseizure Medication With Risk of Autism and Intellectual Disability. JAMA Neurol 2022; :

Bjørk (Controls unexposed, sick) (Mixed indications), 2022

Bjørk Association of Prenatal Exposure to Antiseizure Medication With Risk of Autism and Intellectual Disability. JAMA Neurol 2022; :

Blotière (Controls exposed to Lamotrigine, sick) (Other indications), 2019

Blotière Risks of 23 specific malformations associated with prenatal exposure to 10 antiepileptic drugs. Neurology 2019; 93:e167-e180

Blotière (Controls unexposed NOS) (Other indications), 2019

Blotière Risks of 23 specific malformations associated with prenatal exposure to 10 antiepileptic drugs. Neurology 2019; 93:e167-e180

Christensen (All indications) (Controls exposed to LTG), 2024

Christensen Prenatal exposure to antiseizure medications and fetal growth: a population-based cohort study from the Nordic countries. Lancet Reg Health Eur 2024; 38:100849

Christensen (All indications) (Controls unexposed, general population), 2024

Christensen Prenatal exposure to antiseizure medications and fetal growth: a population-based cohort study from the Nordic countries. Lancet Reg Health Eur 2024; 38:100849

Coste (Controls exposed to Lamotrigine, sick) (Mixed indications), 2020

Blotière Risk of early neurodevelopmental outcomes associated with prenatal exposure to the antiepileptic drugs most commonly used during pregnancy: a French nationwide population-based cohort study. BMJ Open 2020; 10:e034829

Coste Risk of early neurodevelopmental disorders associated with in utero exposure to valproate and other antiepileptic drugs: a nationwide cohort study in France. Sci Rep 2020; 10:17362

Coste (Controls unexposed, NOS) (Mixed indications), 2020

Coste Risk of early neurodevelopmental disorders associated with in utero exposure to valproate and other antiepileptic drugs: a nationwide cohort study in France. Sci Rep 2020; 10:17362

Dreier (Controls exposed to LTG), 2023

Dreier Prenatal Exposure to Antiseizure Medication and Incidence of Childhood- and Adolescence-Onset Psychiatric Disorders. JAMA Neurol 2023; 80:568-577

Dreier (Controls unexposed, sick), 2023

Dreier Prenatal Exposure to Antiseizure Medication and Incidence of Childhood- and Adolescence-Onset Psychiatric Disorders. JAMA Neurol 2023; 80:568-577

Dudukina (Controls exposed to LTG) (Mixed indications), 2023

Dudukina Prenatal exposure to pregabalin, birth outcomes and neurodevelopment - a population-based cohort study in four Nordic countries. Drug Saf 2023; 46:661-675

Toft A Population-based Cohort Study of Pregabalin to Characterize Pregnancy Outcomes A0081359 Non-interventional final study report. 2020; 1-71

Dudukina (Controls unexposed, NOS) (Mixed indications), 2023

Dudukina Prenatal exposure to pregabalin, birth outcomes and neurodevelopment - a population-based cohort study in four Nordic countries. Drug Saf 2023; 46:661-675

Toft A Population-based Cohort Study of Pregabalin to Characterize Pregnancy Outcomes A0081359 Non-interventional final study report. 2020; 1-71

Källén (Controls exposed to Lamotrigine, sick) (Indications NOS), 2013

Källén B The use of central nervous system active drugs during pregnancy. Pharmaceuticals (Basel) 2013;6:1221-86

Källén (Controls unexposed, NOS) (Indications NOS), 2013

Källén B The use of central nervous system active drugs during pregnancy. Pharmaceuticals (Basel) 2013;6:1221-86

Kaskal (Indications NOS), 2024

Kaskal Evaluation of the teratogenic effects of pregabalin usage during pregnancy: A multicenter case-control study. North Clin Istanb 2024; 11:460-465

Kilic (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014

Kilic D Birth outcomes after prenatal exposure to antiepileptic drugs--a population-based study. Epilepsia 2014;55:1714-21

Kilic (Controls unexposed NOS) (Mixed indications), 2014

Kilic D Birth outcomes after prenatal exposure to antiepileptic drugs--a population-based study. Epilepsia 2014;55:1714-21

Kilic (Controls unexposed, sick) (Mixed indications), 2014

Kilic D Birth outcomes after prenatal exposure to antiepileptic drugs--a population-based study. Epilepsia 2014;55:1714-21

Madley-Dowd_SE (Pregabalin) (Controls exposed to LTG) (Mixed indications), 2024

Madley-Dowd Antiseizure medication use during pregnancy and children's neurodevelopmental outcomes. Nat Commun 2024; 15:9640

Madley-Dowd_SE (Pregabalin) (Controls unexposed, general pop) (Mixed indications), 2024

Madley-Dowd Antiseizure medication use during pregnancy and children's neurodevelopmental outcomes. Nat Commun 2024; 15:9640

Madley-Dowd_SE (Pregabalin) (Controls unexposed, sibling) (Mixed indications), 2024

Madley-Dowd Antiseizure medication use during pregnancy and children's neurodevelopmental outcomes. Nat Commun 2024; 15:9640

Madley-Dowd_UK (Pregabalin) (Controls exposed to LTG) (Mixed indications), 2024

Madley-Dowd Antiseizure medication use during pregnancy and children's neurodevelopmental outcomes. Nat Commun 2024; 15:9640

Madley-Dowd_UK (Pregabalin) (Controls unexposed, general pop) (Mixed indications), 2024

Madley-Dowd Antiseizure medication use during pregnancy and children's neurodevelopmental outcomes. Nat Commun 2024; 15:9640

Madley-Dowd_UK (Pregabalin) (Controls unexposed, sibling) (Mixed indications), 2024

Madley-Dowd Antiseizure medication use during pregnancy and children's neurodevelopmental outcomes. Nat Commun 2024; 15:9640

Margulis (Pregabalin) (Indications other than epilepsy), 2019

Margulis Relation of in-utero exposure to antiepileptic drugs to pregnancy duration and size at birth. PLoS One 2019; 14:e0214180

Patorno_MAX and MaketScan (Other indications), 2017

Patorno Pregabalin use early in pregnancy and the risk of major congenital malformations. Neurology 2017; 88:2020-2025

Razaz (Epilepsy), 2024

Razaz Risk of Perinatal and Maternal Morbidity and Mortality Among Pregnant Women With Epilepsy. JAMA Neurol 2024; 81:985-995

The NAAED (Controls exposed to LTG) (Indications NOS), 2023

Hernández-Díaz Comparative safety of antiepileptic drugs during pregnancy. Neurology 2012;78:1692-9

Lewis B. Holmes, M.D. (Director) Risk of malformations for specific AED in monotherapy and the control groups (Latest Study Data - October 2023) https://www.aedpregnancyregistry.org/ (Consulted 05/2022)

Lewis Holmes Risk of malformations for specific AED in monotherapy and the control groups. Latest Study Data - October 2023. https://www.aedpregnancyregistry.org/ (Consulted September 2024)

The NAAED (Controls unexposed, disease free) (Indications NOS), 2023

Hernández-Díaz Comparative safety of antiepileptic drugs during pregnancy. Neurology 2012;78:1692-9

Lewis B. Holmes, M.D. (Director) Risk of malformations for specific AED in monotherapy and the control groups (Annual Update for 2022) https://www.aedpregnancyregistry.org/ (Consulted 05/2022)

Lewis Holmes Risk of malformations for specific AED in monotherapy and the control groups. Latest Study Data - October 2023. https://www.aedpregnancyregistry.org/ (Consulted September 2024)

Wyszynski Increased rate of major malformations in offspring exposed to valproate during pregnancy. Neurology 2005; 64:961-5

Vajda (Controls exposed to Lamotrigine, sick), 2019

Jazayeri Outcomes of pregnancies in women taking antiepileptic drugs for non-epilepsy indications. Seizure 2018; 56:111-114

Vajda Antiepileptic drugs and foetal malformation: analysis of 20 years of data in a pregnancy register. Seizure 2019; 65:6-11

Vajda (Controls unexposed, sick), 2019

Jazayeri Outcomes of pregnancies in women taking antiepileptic drugs for non-epilepsy indications. Seizure 2018; 56:111-114

Vajda Antiepileptic drugs and foetal malformation: analysis of 20 years of data in a pregnancy register. Seizure 2019; 65:6-11

Veiby (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014

Veiby Fetal growth restriction and birth defects with newer and older antiepileptic drugs during pregnancy. J. Neurol. 2014; 261:579-88

Veiby (Controls unexposed, disease free) (Mixed indications), 2014

Veiby Fetal growth restriction and birth defects with newer and older antiepileptic drugs during pregnancy. J. Neurol. 2014; 261:579-88

Veiby (Controls unexposed, sick) (Mixed indications), 2014

Veiby Fetal growth restriction and birth defects with newer and older antiepileptic drugs during pregnancy. J. Neurol. 2014; 261:579-88

Winterfeld (Other indications), 2016

Winterfeld Pregnancy outcome following maternal exposure to pregabalin may call for concern. Neurology 2016; 86:2251-7