Primidone AND Phenobarbital (Epilepsy)

Table   Graphic  
individual studies
OutcomeTE95% CIn casesn exposedkPub. bias Congenital malformations All congenital malformations (majors, minors, majors and minors, or unspecified) Lowe (Phenobarbital or Primidone) (Controls unexposed, sick), 1973 Robert (Phenobarbital), 1986 D'Souza (Phenobarbital) (Controls unexposed, sick), 1991 Kaneko (Phenobarbital or Primidone), 1999 Samrén (Phenobarbital or Primidone), 1999 Canger (Phenobarbital or Primidone), 1999 Dean (Phenobarbital or Primidone), 2002 Kaaja (Phenobarbital or Primidone), 2003 Endo (Phenobarbital) (Controls unexposed, sick), 2004 Bànhidy (Phenobarbital or Primidone), 2011 Hernández-Díaz (Phenobarbital) (Controls unexposed, disease free), 2012 Veiby (Phenobarbital) (Controls unexposed, sick), 2014 Tomson (Phenobarbital or Primidone), 2018 Vajda (Phenobarbital or Primidone) (Controls unexposed, sick), 2019 Thomas (Phenobarbital) (Controls unexposed, sick), 2021 152.13[1.55; 2.92]3721,321low Major congenital malformations Robert (Phenobarbital), 1986 Canger (Phenobarbital or Primidone), 1999 Samrén (Phenobarbital or Primidone), 1999 Dean (Phenobarbital or Primidone), 2002 Kaaja (Phenobarbital or Primidone), 2003 Bànhidy (Phenobarbital or Primidone), 2011 Hernández-Díaz (Phenobarbital) (Controls unexposed, disease free), 2012 Veiby (Phenobarbital) (Controls unexposed, sick), 2014 Tomson (Phenobarbital or Primidone), 2018 Vajda (Phenobarbital or Primidone) (Controls unexposed, sick), 2019 Thomas (Phenobarbital) (Controls unexposed, sick), 2021 112.11[1.51; 2.94]3151,131low Congenital heart defects Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 D'Souza (Phenobarbital) (Controls unexposed, sick), 1991 Bànhidy (Phenobarbital or Primidone), 2011 Hernández-Díaz (Phenobarbital) (Controls exposed to Lamotrigine, sick), 2012 Tomson (Phenobarbital or Primidone), 2018 Thomas (Phenobarbital) (Controls unexposed, sick), 2021 63.06[1.17; 8.01]53652not evaluable Hypospadias Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 D'Souza (Phenobarbital) (Controls unexposed, sick), 1991 Bànhidy (Phenobarbital or Primidone), 2011 Hernández-Díaz (Phenobarbital) (Controls exposed to Lamotrigine, sick), 2012 Tomson (Phenobarbital or Primidone), 2018 51.84[0.47; 7.29]11515not evaluable Microcephaly / Small head circumference for gestational age Kelly (Phenobarbital), 1984 Dravet (Phenobarbital), 1992 Battino (Phenobarbital or Primidone), 1999 Díaz-Romero (Phenobarbital), 1999 Holmes (Phenobarbital) (Controls unexposed, sick), 2001 52.55[1.08; 6.05]45248serious Minor congenital malformations Robert (Phenobarbital), 1986 Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 Battino (Phenobarbital or Primidone) , 1992 Dean (Phenobarbital or Primidone), 2002 41.93[0.91; 4.11]66206not evaluable Spina bifida Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 Czeizel (Primidone), 1992 Veiby (Phenobarbital) (Controls unexposed, sick), 2014 32.07[0.12; 37.21]533not evaluable Hip dislocation and/or dysplasia D'Souza (Phenobarbital) (Controls unexposed, sick), 1991 Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 24.08[0.31; 53.22]116not evaluable Neural Tube Defects Canger (Phenobarbital or Primidone), 1999 Bànhidy (Phenobarbital or Primidone), 2011 Hernández-Díaz (Phenobarbital) (Controls exposed to Lamotrigine, sick), 2012 Tomson (Phenobarbital or Primidone), 2018 41.93[0.27; 13.89]6617not evaluable Polydactyly D'Souza (Phenobarbital) (Controls unexposed, sick), 1991 Bànhidy (Phenobarbital or Primidone), 2011 Tomson (Phenobarbital or Primidone), 2018 33.40[0.17; 69.72]4304not evaluable Club foot / Talipes equinovarus Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 Bànhidy (Phenobarbital or Primidone), 2011 23.39[0.26; 44.38]119not evaluable Urinary malformations Tomson (Phenobarbital or Primidone), 2018 Thomas (Phenobarbital) (Controls unexposed, sick), 2021 20.59[0.11; 3.19]15431not evaluable Ano-rectal atresia and stenosis Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 10.59[0.02; 15.81]112not evaluable Cleft lip with or without cleft palate Lowe (Phenobarbital or Primidone) (Controls unexposed, sick), 1973 15.97[0.24; 149.03]157not evaluable Congenital cataract Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 10.59[0.02; 15.81]112not evaluable Craniosynostosis D'Souza (Phenobarbital) (Controls unexposed, sick), 1991 12.14[0.03; 131.94]-4not evaluable Digestive system anomalies Thomas (Phenobarbital) (Controls unexposed, sick), 2021 10.83[0.03; 20.42]1137not evaluable Down syndrom / Trisomy 21 D'Souza (Phenobarbital) (Controls unexposed, sick), 1991 12.14[0.03; 131.94]-4not evaluable Limb defects Thomas (Phenobarbital) (Controls unexposed, sick), 2021 12.50[0.35; 17.96]4137not evaluable Nervous system anomalies Thomas (Phenobarbital) (Controls unexposed, sick), 2021 17.52[0.30; 185.67]1137not evaluable Oro-facial clefts Hernández-Díaz (Phenobarbital) (Controls exposed to Lamotrigine, sick), 2012 Tomson (Phenobarbital or Primidone), 2018 24.09[1.38; 12.13]15493not evaluable Eye defects Dean (Phenobarbital or Primidone), 2002 10.89[0.29; 2.73]1563not evaluable Growth parameters and prematurity Small for gestational age (weight) Endo (Phenobarbital) (Controls unexposed, sick), 2004 Burja (Phenobarbital or Primidone) (Controls unexposed, sick), 2006 Hernández-Díaz (Phenobarbital), 2017 Coste (Phenobarbital) (Controls unexposed, NOS), 2020 Christensen (Phenobarbital) (Epilepsy) (Controls unexposed, general population), 2024 52.19[1.44; 3.35]169,818321not evaluable Preterm (< 37 weeks) Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 Koch (Phenobarbital or Primidone), 1996 Endo (Phenobarbital) (Controls unexposed, sick), 2004 Coste (Phenobarbital) (Controls unexposed, NOS), 2020 Leite (Phenobarbital), 2024 51.20[0.42; 3.41]91,358194not evaluable Low birth weight (< 2500g) Coste (Phenobarbital) (Controls unexposed, NOS), 2020 Christensen (Primidone) (Epilepsy) (Controls unexposed, general population), 2024 Leite (Phenobarbital), 2024 31.47[0.50; 4.31]92,575181not evaluable Macrosomia (> 4000g) Endo (Phenobarbital) (Controls unexposed, sick), 2004 Coste (Phenobarbital) (Controls unexposed, NOS), 2020 20.49[0.29; 0.82]577,11494not evaluable Extremely preterm (< 28 weeks) Coste (Phenobarbital) (Controls unexposed, NOS), 2020 15.01[0.31; 80.81]2,04184not evaluable Very preterm (28 to 32 weeks) Coste (Phenobarbital) (Controls unexposed, NOS), 2020 12.39[0.33; 17.16]8,58584not evaluable Large head circumference for gestational age Díaz-Romero (Phenobarbital), 1999 15.00[0.07; 366.35]-2not evaluable Maternal consequences Assisted deliveries (forceps, vacuum, ...) Endo (Phenobarbital) (Controls unexposed, sick), 2004 10.05[0.00; 6.68]-10not evaluable Caesarean Endo (Phenobarbital) (Controls unexposed, sick), 2004 10.18[0.00; 12.84]110not evaluable Polyhydramnios Endo (Phenobarbital) (Controls unexposed, sick), 2004 10.05[0.00; 6.68]-10not evaluable Neonatal disorders Feeding difficulty D'Souza (Phenobarbital) (Controls unexposed, sick), 1991 Yerby (Phenobarbital), 1992 Burja (Phenobarbital or Primidone) (Controls unexposed, sick), 2006 34.51[0.63; 32.30]316not evaluable Neonatal disorders (as a whole) D'Souza (Phenobarbital) (Controls unexposed, sick), 1991 Coste (Phenobarbital) (Controls unexposed, NOS), 2020 20.77[0.39; 1.52]222,21288not evaluable Low Apgar score (< 7) (at 1 min) Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 Endo (Phenobarbital) (Controls unexposed, sick), 2004 20.55[0.02; 15.67]222not evaluable Neonatal intracranial hemorrhage D'Souza (Phenobarbital) (Controls unexposed, sick), 1991 Burja (Phenobarbital or Primidone) (Controls unexposed, sick), 2006 23.06[0.22; 43.15]26not evaluable Withdrawal syndrome / Neonatal abstinence syndrome / Poor neonatal adaptation Burja (Phenobarbital or Primidone) (Controls unexposed, sick), 2006 121.00[0.30; 1469.95]-2not evaluable Cerebral palsy Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 11.87[0.03; 100.54]-12not evaluable Jaundice / Icterus D'Souza (Phenobarbital) (Controls unexposed, sick), 1991 10.62[0.02; 19.59]14not evaluable Neonatal hypotonia D'Souza (Phenobarbital) (Controls unexposed, sick), 1991 12.14[0.03; 131.94]-4not evaluable Neonatal infections D'Souza (Phenobarbital) (Controls unexposed, sick), 1991 12.14[0.03; 131.94]-4not evaluable Neonatal medical care D'Souza (Phenobarbital) (Controls unexposed, sick), 1991 12.14[0.03; 131.94]-4not evaluable Neonatal tachypnea D'Souza (Phenobarbital) (Controls unexposed, sick), 1991 12.14[0.03; 131.94]-4not evaluable Long term consequences Child/Infant death (> 28 days of life) Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 Coste (Phenobarbital) (Controls unexposed, NOS), 2020 21.27[0.15; 10.56]4,69697not evaluable Intrauterine deaths Intrauterine deaths (as a whole or unspecified) Tomson (Phenobarbital), 2015 Miškov (Phenobarbital) (Controls unexposed, sick), 2016 Trivedi (Phenobarbital) (Controls unexposed, sick), 2018 31.67[0.62; 4.44]183401not evaluable Early intrauterine deaths (< 22 weeks) / Spontaneous abortions Tomson (Phenobarbital), 2015 Miškov (Phenobarbital) (Controls unexposed, sick), 2016 21.06[0.63; 1.79]165263not evaluable Elective/induced termination of pregnancy Miškov (Phenobarbital) (Controls unexposed, sick), 2016 11.40[0.02; 97.44]-3not evaluable Therapeutic terminations of pregnancy Miškov (Phenobarbital) (Controls unexposed, sick), 2016 11.40[0.02; 97.44]-3not evaluable Perinatal death Canger (Phenobarbital or Primidone), 1999 Tomson (Phenobarbital), 2015 20.59[0.05; 6.30]3356not evaluable Late intrauterine deaths (> 22 weeks) / Stillbirths Tomson (Phenobarbital), 2015 12.46[0.49; 12.25]8260not evaluable Neuro-developmental disorders Language disorders/delay Kasradze (Phenobarbital) (Controls unexposed, disease free), 2017 Coste (Phenobarbital) (Controls unexposed, NOS), 2020 Thomas a (Phenobarbitone), 2022 Adams (Phenobarbital), 2022 42.51[1.33; 4.74]72,019133not evaluable Neuro-developmental disorders (as a whole) Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 Katz (Phenobarbital or Primidone), 2001 Dean (Phenobarbital) (Controls unexposed, sick), 2007 Coste (Phenobarbital) (Controls unexposed, NOS), 2020 41.60[0.64; 4.00]10,030153not evaluable Cognitive developmental disorders/delay (3-6 years old) Kasradze (Phenobarbital) (Controls unexposed, disease free), 2017 Coste (Phenobarbital) (Controls unexposed, NOS), 2020 27.18[1.16; 44.46]3,39987not evaluable Cognitive developmental disorders/delay (> 6 years old) Titze (Phenobarbital or Primidone) (Controls unexposed, sick), 2008 Adams (Phenobarbital), 2022 Thomas a (Phenobarbitone), 2022 32.70[1.28; 5.68]158not evaluable ASD (Autism spectrum disorder): Diagnosis Coste (Phenobarbital) (Controls unexposed, NOS), 2020 12.39[0.15; 38.48]4,28084not evaluable ASD (Autism spectrum disorder): Diagnosis/Risk Coste (Phenobarbital) (Controls unexposed, NOS), 2020 12.39[0.15; 38.48]4,28084not evaluable Cognitive developmental disorders/delay (< 3 years old) Kelly (Phenobarbital), 1984 Thomas b (Phenobarbitone) (Controls unexposed, sick), 2022 21.06[0.14; 8.09]396not evaluable Psychomotor developmental disorders/delay Koch (Phenobarbital or Primidone), 1996 Thomas b (Phenobarbitone) (Controls unexposed, sick), 2022 21.34[0.82; 2.21]698not evaluable Severe cognitive developmental delay (Mental retardation) (3-6 years old) Coste (Phenobarbital) (Controls unexposed, NOS), 2020 13.00[0.41; 21.94]3,39984not evaluable Learning disorders Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 113.75[1.48; 127.48]77not evaluable Severe cognitive developmental delay (Mental retardation) (> 6 years old) Titze (Phenobarbital or Primidone) (Controls unexposed, sick), 2008 10.33[0.01; 9.07]112not evaluable0.0100.01.0

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