Primidone AND Phenobarbital (All indications)

Study Reference
Adams (Phenobarbital), 2022

Adams Neuropsychological effects in children exposed to anticonvulsant monotherapy during gestation: Phenobarbital, carbamazepine, and phenytoin. Epilepsy Behav 2022; 127:108533

Al Bunyan (Phenobarbital), 1999

Al Bunyan Outcome of pregnancies in epileptic women: a study in Saudi Arabia.,Outcome of pregnancies in epileptic women: a study in Saudi Arabia. Seizure 1999; 8:26-9

Bànhidy (Phenobarbital or Primidone), 2011

Bànhidy Efficacy of medical care of epileptic pregnant women based on the rate of congenital abnormalities in their offspring. Congenit Anom (Kyoto) 2011; 51:34-42

Barroso (Phenobarbital), 2015

Barroso Perinatal outcomes from the use of antiepileptic drugs during pregnancy: a case-control study. J Matern Fetal Neonatal Med 2015; 28:1445-50

Battino (Phenobarbital or Primidone), 1992

Battino Malformations in offspring of 305 epileptic women: a prospective study. Acta Neurol. Scand. 1992; 85:204-7

Canger R Malformations in offspring of women with epilepsy: a prospective study. Epilepsia 1999;40:1231-6

Battino (Phenobarbital or Primidone), 1999

Battino D Intrauterine growth in the offspring of epileptic women: a prospective multicenter study. Epilepsy Res 1999;36:53-60

Bech (Phenobarbital) (Controls exposed to Lamotrigine, sick) (Other indications), 2018

Bech In utero exposure to antiepileptic drugs is associated with learning disabilities among offspring. J Neurol Neurosurg Psychiatry 2018; 89:1324-1331

Bech (Phenobarbital) (Controls unexposed, sick) (Other indications), 2018

Bech In utero exposure to antiepileptic drugs is associated with learning disabilities among offspring. J Neurol Neurosurg Psychiatry 2018; 89:1324-1331

Bjørk (Phenobarbital) (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 (Phenobarbital) (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 (Phenobarbital) (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 (Phenobarbital) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2019

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

Blotière (Phenobarbital) (Controls unexposed NOS) (Mixed indications), 2019

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

Burja (Phenobarbital or Primidone) (Controls unexposed, disease free), 2006

Burja The frequency of neonatal morbidity after exposure to antiepileptic drugs in utero: a retrospective population-based study. Wien. Klin. Wochenschr. 2006; 118 Suppl 2:12-6

Burja (Phenobarbital or Primidone) (Controls unexposed, sick), 2006

Burja The frequency of neonatal morbidity after exposure to antiepileptic drugs in utero: a retrospective population-based study. Wien. Klin. Wochenschr. 2006; 118 Suppl 2:12-6

Canger (Phenobarbital or Primidone), 1999

Canger R Malformations in offspring of women with epilepsy: a prospective study. Epilepsia 1999;40:1231-6

Cassina (Phenobarbital) (Controls exposed to Lamotrigine, sick) (Other indications), 2013

Cassina M Pregnancy outcome in women exposed to antiepileptic drugs: teratogenic role of maternal epilepsy and its pharmacologic treatment. Reprod Toxicol 2013;39:50-7

Cassina (Phenobarbital) (Controls unexposed, disease free) (Other indications), 2013

Cassina M Pregnancy outcome in women exposed to antiepileptic drugs: teratogenic role of maternal epilepsy and its pharmacologic treatment. Reprod Toxicol 2013;39:50-7

Christensen (Phenobarbital) (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 (Phenobarbital) (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 (Phenobarbital) (Controls exposed to Lamotrigine, sick), 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

Coste (Phenobarbital) (Controls unexposed, NOS), 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

D'Souza (Phenobarbital) (Controls unexposed, disease free), 1991

D'Souza Fetal phenytoin exposure, hypoplastic nails, and jitteriness. Arch Dis Child 1991; 66:320-4

D'Souza (Phenobarbital) (Controls unexposed, sick), 1991

D'Souza Fetal phenytoin exposure, hypoplastic nails, and jitteriness. Arch Dis Child 1991; 66:320-4

Dean (Phenobarbital or Primidone), 2002

Dean Fetal anticonvulsant syndromes and polymorphisms in MTHFR, MTR, and MTRR. Am. J. Med. Genet. A 2007; 143A:2303-11

Dean JC Long term health and neurodevelopment in children exposed to antiepileptic drugs before birth. J Med Genet 2002;39:251-9

Dean (Phenobarbital) (Controls exposed to Lamotrigine, sick), 2007

Dean Fetal anticonvulsant syndromes and polymorphisms in MTHFR, MTR, and MTRR. Am J Med Genet A 2007; 143A:2303-11

Dean Long term health and neurodevelopment in children exposed to antiepileptic drugs before birth. J Med Genet 2002; 39:251-9

Dean (Phenobarbital) (Controls unexposed, sick), 2007

Dean Fetal anticonvulsant syndromes and polymorphisms in MTHFR, MTR, and MTRR. Am J Med Genet A 2007; 143A:2303-11

Dean Long term health and neurodevelopment in children exposed to antiepileptic drugs before birth. J Med Genet 2002; 39:251-9

Díaz-Romero (Phenobarbital), 1999

Díaz-Romero Facial anthropometric measurements in offspring of epileptic mothers. Arch Med Res ; 30:186-9

Dravet (Phenobarbital), 1992

Dravet Epilepsy, antiepileptic drugs, and malformations in children of women with epilepsy: a French prospective cohort study. Neurology 1992; 42:75-82

Elkjaer (Phenobarbital), 2018

Elkjaer Association Between Prenatal Valproate Exposure and Performance on Standardized Language and Mathematics Tests in School-aged Children. JAMA Neurol 2018; 75:663-671

Endo (Phenobarbital) (Controls unexposed, disease free), 2004

Endo Statistics on deliveries of mothers with epilepsy at Yokohama City University Hospital. Epilepsia 2004; 45 Suppl 8:42-7

Endo (Phenobarbital) (Controls unexposed, sick), 2004

Endo Statistics on deliveries of mothers with epilepsy at Yokohama City University Hospital. Epilepsia 2004; 45 Suppl 8:42-7

Fedrick (Phenobarbital), 1973

Fedrick Epilepsy and pregnancy: a report from the Oxford Record Linkage Study. Br Med J 1973; 2:442-8

Hernández-Díaz (Phenobarbital), 2017

Hernández-Díaz Fetal growth and premature delivery in pregnant women on antiepileptic drugs. Ann Neurol 2017; 82:457-465

Hernández-Díaz (Phenobarbital) (Controls exposed to Lamotrigine, sick), 2012

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

Hernández-Díaz (Phenobarbital) (Controls unexposed, disease free), 2012

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

Holmes (Phenobarbital) (Controls unexposed, disease free), 2001

Holmes The teratogenicity of anticonvulsant drugs. N Engl J Med 2001; 344:1132-8

Holmes (Phenobarbital) (Controls unexposed, sick), 2001

Holmes The teratogenicity of anticonvulsant drugs. N Engl J Med 2001; 344:1132-8

Kaaja (Phenobarbital or Primidone), 2003

Kaaja E Major malformations in offspring of women with epilepsy. Neurology 2003;60:575-9

Källén (Phenobarbital or Primidone) (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

Wide K Major malformations in infants exposed to antiepileptic drugs in utero, with emphasis on carbamazepine and valproic acid: a nation-wide, population-based register study. Acta Paediatr 2004;93:174-6

Källén (Phenobarbital or Primidone) (Controls unexposed, NOS) (Indications NOS), 2013

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

Kaneko (Phenobarbital or Primidone), 1999

Battino Malformations in offspring of 305 epileptic women: a prospective study. Acta Neurol. Scand. 1992; 85:204-7

Canger R Malformations in offspring of women with epilepsy: a prospective study. Epilepsia 1999;40:1231-6

Dansky Major congenital malformations in the offspring of epileptic patients: genetic and environmental risk factors. In: Epilepsy, Pregnancy and the Child. edn. Edited by Janz D, Bossi L, Dam M, Helge H, Richens A, Schmidt D. New York: Raven Press; 1982

Kaneko S Congenital malformations due to antiepileptic drugs. Epilepsy Res 1999;33:145-58

Kaneko S Teratogenicity of antiepileptic drugs: analysis of possible risk factors. Epilepsia 1988;29:459-67

Oguni Improved pregnancy outcome in epileptic women in the last decade: relationship to maternal anticonvulsant therapy. Brain Dev. 1992; 14:371-80

Kasradze (Phenobarbital) (Controls exposed to Lamotrigine, sick), 2017

Kasradze Cognitive functions in children exposed to antiepileptic drugs in utero - Study in Georgia. Epilepsy Behav 2017; 66:105-112

Kasradze (Phenobarbital) (Controls unexposed, disease free), 2017

Kasradze Cognitive functions in children exposed to antiepileptic drugs in utero - Study in Georgia. Epilepsy Behav 2017; 66:105-112

Katz (Phenobarbital or Primidone), 2001

Katz Current Management of Epilepsy and Pregnancy: Fetal Outcome, Congenital Malformations, and Developmental Delay.,Current Management of Epilepsy and Pregnancy: Fetal Outcome, Congenital Malformations, and Developmental Delay. Epilepsy Behav 2001; 2:119-123

Kelly (Phenobarbital), 1984

Kelly Teratogenicity of anticonvulsant drugs. II: A prospective study. Am J Med Genet 1984; 19:435-43

Kilic (Phenobarbital or Primidone) (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 (Phenobarbital or Primidone) (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 (Phenobarbital or Primidone) (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

Kini (Phenobarbital or Primidone) (Controls exposed to Lamotrigine, sick), 2006

Kini U Dysmorphic features: an important clue to the diagnosis and severity of fetal anticonvulsant syndromes. Arch Dis Child Fetal Neonatal Ed 2006;91:F90-5

Kini (Phenobarbital or Primidone) (Controls unexposed, sick), 2006

Kini U Dysmorphic features: an important clue to the diagnosis and severity of fetal anticonvulsant syndromes. Arch Dis Child Fetal Neonatal Ed 2006;91:F90-5

Koch (Phenobarbital or Primidone), 1996

Koch S Antiepileptic drug treatment in pregnancy: drug side effects in the neonate and neurological outcome. Acta Paediatr 1996;85:739-46

Leite (Phenobarbital) (Epilepsy), 2024

Leite Obstetric and neonatal outcomes, antiseizure medication profile, and seizure types in pregnant women in a vulnerability state from Brazil. PLoS One 2024; 19:e0291190

Lowe (Phenobarbital or Primidone) (Controls unexposed, disease free), 1973

Lowe CR Congenital malformations among infants born to epileptic women. Lancet 1973;1:9-10

Lowe (Phenobarbital or Primidone) (Controls unexposed, sick), 1973

Lowe CR Congenital malformations among infants born to epileptic women. Lancet 1973;1:9-10

Miškov (Phenobarbital) (Controls exposed to Lamotrigine, sick), 2016

Miskov Croatian Pregnant Women with Epilepsy and Effects of Antiepileptic Drugs Exposure in their Offspring - seven years of prospective surveillance. American Epilepsy Society; Texas 2010

Miskov The Croatian Model of Integrative Prospective Management of Epilepsy and Pregnancy Acta Clin Croat 2016; 55:535-548

Miškov (Phenobarbital) (Controls unexposed, disease free), 2016

Miskov Croatian Pregnant Women with Epilepsy and Effects of Antiepileptic Drugs Exposure in their Offspring - seven years of prospective surveillance. American Epilepsy Society; Texas 2010

Miskov The Croatian Model of Integrative Prospective Management of Epilepsy and Pregnancy Acta Clin Croat 2016; 55:535-548

Miškov (Phenobarbital) (Controls unexposed, sick), 2016

Miskov Croatian Pregnant Women with Epilepsy and Effects of Antiepileptic Drugs Exposure in their Offspring - seven years of prospective surveillance. American Epilepsy Society; Texas 2010

Miskov The Croatian Model of Integrative Prospective Management of Epilepsy and Pregnancy Acta Clin Croat 2016; 55:535-548

Robert (Phenobarbital), 1986

Robert Evaluation of drug therapy and teratogenic risk in a Rhone-Alpes district population of pregnant epileptic women. Eur Neurol 1986; 25:436-43

Samrén (Phenobarbital or Primidone), 1999

Samr?n Antiepileptic drug regimens and major congenital abnormalities in the offspring.,Antiepileptic drug regimens and major congenital abnormalities in the offspring. Ann. Neurol. 1999; 46:739-46

Shankaran (Phenobarbital) (Other indications), 1996

Shankaran Antenatal phenobarbital therapy and neonatal outcome. II: Neurodevelopmental outcome at 36 months.,Antenatal phenobarbital therapy and neonatal outcome. II: Neurodevelopmental outcome at 36 months. Pediatrics 1996; 97:649-52

Shankaran Neurodevelopmental outcome of premature infants after antenatal phenobarbital exposure. Am J Obstet Gynecol 2002; 187:171-7

Shankaran (Phenobarbital) (Other indications), 2002

Shankaran Neurodevelopmental outcome of premature infants after antenatal phenobarbital exposure. Am J Obstet Gynecol 2002; 187:171-7

Steegers-Theunissen (Phenobarbital or Primidone), 1994

Steegers-Theunissen Factors influencing the risk of abnormal pregnancy outcome in epileptic women: a multi-centre prospective study.,Factors influencing the risk of abnormal pregnancy outcome in epileptic women: a multi-centre prospective study. Epilepsy Res. 1994; 18:261-9

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

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

Holmes North American antiepileptic drug pregnancy registry. Epilepsia 2004; 45:1465

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 (Phenobarbital) (Controls unexposed, disease free) (Indications NOS), 2023

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

Holmes North American antiepileptic drug pregnancy registry. Epilepsia 2004; 45:1465

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

Thomas (Phenobarbital) (Controls exposed to Lamotrigine, sick), 2021

Keni Teratogenicity of antiepileptic dual therapy: Dose-dependent, drug-specific, or both? Neurology 2018; 90:e790-e796

Thomas Malformation risk of antiepileptic drug exposure during pregnancy in women with epilepsy: Results from a pregnancy registry in South India. Epilepsia 2017; 58:274-281

Thomas Malformation risk of new anti-epileptic drugs in women with epilepsy; observational data from the Kerala registry of epilepsy and pregnancy (KREP). Seizure 2021; 93:127-132

Thomas (Phenobarbital) (Controls unexposed, disease free), 2021

Thomas Malformation risk of antiepileptic drug exposure during pregnancy in women with epilepsy: Results from a pregnancy registry in South India. Epilepsia 2017; 58:274-281

Thomas (Phenobarbital) (Controls unexposed, sick), 2021

Thomas Cardiac malformations are increased in infants of mothers with epilepsy. Pediatr Cardiol 2008; 29:604-8

Thomas Malformation risk of antiepileptic drug exposure during pregnancy in women with epilepsy: Results from a pregnancy registry in South India. Epilepsia 2017; 58:274-281

Thomas Malformation risk of new anti-epileptic drugs in women with epilepsy; observational data from the Kerala registry of epilepsy and pregnancy (KREP). Seizure 2021; 93:127-132

Thomas a (Phenobarbital), 2008

Thomas Cardiac malformations are increased in infants of mothers with epilepsy. Pediatr Cardiol 2008; 29:604-8

Thomas a (Phenobarbitone), 2022

Gopinath Children (10-12 years age) of women with epilepsy have lower intelligence, attention and memory: Observations from a prospective cohort case control study. Epilepsy Res 2015; 117:58-62

Sreedharan Reduced brain volumes in children of women with epilepsy: A neuropsychological and voxel based morphometric analysis in pre-adolescent children. J Neuroradiol 2018; 45:380-385

Thomas Intellectual and language functions in children of mothers with epilepsy. Epilepsia 2007; 48:2234-40

Thomas Language, intelligence, and educational outcomes of adolescents with antenatal exposure to antiseizure medications: Prospective data from the Kerala Registry of epilepsy and pregnancy. Seizure 2022; 100:76-81

Thomas b (Phenobarbitone) (Epilepsy) (Controls exposed to LTG), 2022

Thomas Motor and mental development of infants exposed to antiepileptic drugs in utero. Epilepsy Behav 2008; 13:229-36

Thomas, S.V. Differential impact of antenatal exposure to antiseizure medications on motor and mental development in infants of women with epilepsy Epileptic Disord. 2022; 24:531-.

Thomas b (Phenobarbitone) (Epilepsy) (Controls unexposed, sick), 2022

Thomas Motor and mental development of infants exposed to antiepileptic drugs in utero. Epilepsy Behav 2008; 13:229-36

Thomas, S.V. Differential impact of antenatal exposure to antiseizure medications on motor and mental development in infants of women with epilepsy Epileptic Disord. 2022; 24:531-.

Titze (Phenobarbital or Primidone) (Controls unexposed, disease free), 2008

Titze Prenatal and family risks of children born to mothers with epilepsy: effects on cognitive development. Dev Med Child Neurol 2008; 50:117-22

Titze (Phenobarbital or Primidone) (Controls unexposed, sick), 2008

Titze Prenatal and family risks of children born to mothers with epilepsy: effects on cognitive development. Dev Med Child Neurol 2008; 50:117-22

Tomson (Phenobarbital or Primidone), 2018

Martínez Ferri M [Malformations and fetal death in the Spanish antiepileptic drug and pregnancy registry: results at 6 years]. Neurologia 2009;24:360-5

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

Tomson (Phenobarbital), 2015

Tomson Antiepileptic drugs and intrauterine death: A prospective observational study from EURAP. Neurology 2015; 85:580-8

Trivedi (Phenobarbital) (Controls exposed to Lamotrigine, sick), 2018

Trivedi Spontaneous fetal loss in women with epilepsy: prospective data from pregnancy registry in India. Epilepsy Res 2018; 146:50-53

Vajda (Phenobarbital or Primidone) (Controls exposed to Lamotrigine, sick), 2019

Vajda Associations between particular types of fetal malformation and antiepileptic drug exposure in utero. Acta Neurol. Scand. 2013; 128:228-34

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

Vajda FJ The teratogenicity of the newer antiepileptic drugs - an update. Acta Neurol Scand 2014;130:234-8

Vajda (Phenobarbital or Primidone) (Controls unexposed, sick), 2019

Vajda Associations between particular types of fetal malformation and antiepileptic drug exposure in utero. Acta Neurol. Scand. 2013; 128:228-34

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

Vajda FJ The teratogenicity of the newer antiepileptic drugs - an update. Acta Neurol Scand 2014;130:234-8

Van der Pol (Phenobarbital) (Controls unexposed, disease free), 1991

van der Pol Antiepileptic medication in pregnancy: late effects on the children's central nervous system development. Am J Obstet Gynecol 1991; 164:121-8

Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991

van der Pol Antiepileptic medication in pregnancy: late effects on the children's central nervous system development. Am J Obstet Gynecol 1991; 164:121-8

Veiby (Phenobarbital) (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 (Phenobarbital) (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 (Phenobarbital) (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

Waters (Phenobarbital) (Controls unexposed, disease free), 1994

Waters Outcomes of pregnancy associated with antiepileptic drugs. Arch Neurol 1994; 51:250-3

Waters (Phenobarbital) (Controls unexposed, sick), 1994

Waters Outcomes of pregnancy associated with antiepileptic drugs. Arch Neurol 1994; 51:250-3

Yerby (Phenobarbital), 1992

Yerby Antiepileptics and the development of congenital anomalies. Neurology 1992; 42:132-40