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) (Controls unexposed, sick), 1973 Robert (Phenobarbital), 1986 D'Souza (Phenobarbital) (Controls unexposed, sick), 1991 Kaneko (Phenobarbital), 1999 Canger (Phenobarbital), 1999 Samrén (Phenobarbital), 1999 Dean (Phenobarbital), 2002 Kaaja (Phenobarbital), 2003 Endo (Phenobarbital) (Controls unexposed, sick), 2004 Bànhidy (Phenobarbital), 2011 Hernández-Díaz (Phenobarbital) (Controls unexposed, disease free), 2012 Veiby (Phenobarbital) (Controls unexposed, sick), 2014 Tomson (Phenobarbital), 2018 Vajda (Phenobarbital) (Controls unexposed, sick), 2019 Thomas (Phenobarbital) (Controls unexposed, sick), 2021 152.19[1.60; 3.00]3561,169low Major congenital malformations Robert (Phenobarbital), 1986 Samrén (Phenobarbital), 1999 Canger (Phenobarbital), 1999 Dean (Phenobarbital), 2002 Kaaja (Phenobarbital), 2003 Bànhidy (Phenobarbital), 2011 Hernández-Díaz (Phenobarbital) (Controls unexposed, disease free), 2012 Veiby (Phenobarbital) (Controls unexposed, sick), 2014 Tomson (Phenobarbital), 2018 Vajda (Phenobarbital) (Controls unexposed, sick), 2019 Thomas (Phenobarbital) (Controls unexposed, sick), 2021 112.21[1.56; 3.15]3051,018low Congenital heart defects Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 D'Souza (Phenobarbital) (Controls unexposed, sick), 1991 Hernández-Díaz (Phenobarbital) (Controls exposed to Lamotrigine, sick), 2012 Tomson (Phenobarbital), 2018 Thomas (Phenobarbital) (Controls unexposed, sick), 2021 53.93[1.79; 8.63]48646not evaluable Hypospadias Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 D'Souza (Phenobarbital) (Controls unexposed, sick), 1991 Hernández-Díaz (Phenobarbital) (Controls exposed to Lamotrigine, sick), 2012 Tomson (Phenobarbital), 2018 42.91[0.65; 13.10]8509not evaluable Microcephaly / Small head circumference for gestational age Kelly (Phenobarbital), 1984 Dravet (Phenobarbital), 1992 Battino (Phenobarbital), 1999 Díaz-Romero (Phenobarbital), 1999 Holmes (Phenobarbital) (Controls unexposed, sick), 2001 52.50[1.04; 5.99]38214serious Minor congenital malformations Robert (Phenobarbital), 1986 Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 Battino (Phenobarbital), 1992 Dean (Phenobarbital), 2002 41.92[0.88; 4.18]59173not 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), 1999 Hernández-Díaz (Phenobarbital) (Controls exposed to Lamotrigine, sick), 2012 Tomson (Phenobarbital), 2018 32.92[0.29; 29.59]5576not evaluable Polydactyly D'Souza (Phenobarbital) (Controls unexposed, sick), 1991 Tomson (Phenobarbital), 2018 213.45[0.76; 236.46]2298not evaluable Spina bifida Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 Veiby (Phenobarbital) (Controls unexposed, sick), 2014 24.53[0.09; 216.52]430not evaluable Urinary malformations Tomson (Phenobarbital), 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) (Controls unexposed, sick), 1973 16.44[0.26; 160.73]153not evaluable Club foot / Talipes equinovarus Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 11.87[0.03; 100.54]-12not 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), 2018 24.09[1.38; 12.13]15493not evaluable Eye defects Dean (Phenobarbital), 2002 10.92[0.30; 2.84]1561not evaluable Growth parameters and prematurity Preterm (< 37 weeks) Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 Koch (Phenobarbital), 1996 Endo (Phenobarbital) (Controls unexposed, sick), 2004 Coste (Phenobarbital) (Controls unexposed, NOS), 2020 41.13[0.50; 2.55]91,265110not evaluable Small for gestational age (weight) Endo (Phenobarbital) (Controls unexposed, sick), 2004 Burja (Phenobarbital) (Controls unexposed, sick), 2006 Hernández-Díaz (Phenobarbital), 2017 Coste (Phenobarbital) (Controls unexposed, NOS), 2020 42.36[1.62; 3.45]167,394273not 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 Low birth weight (< 2500g) Coste (Phenobarbital) (Controls unexposed, NOS), 2020 12.95[1.60; 5.44]91,46784not 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) (Controls unexposed, sick), 2006 35.62[0.72; 44.00]315not 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) (Controls unexposed, sick), 2006 25.02[0.27; 92.72]25not evaluable Withdrawal syndrome / Neonatal abstinence syndrome / Poor neonatal adaptation Burja (Phenobarbital) (Controls unexposed, sick), 2006 163.00[0.51; 7760.63]-1not evaluable Cerebral palsy Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 11.87[0.03; 100.54]-12not evaluable Jaundice 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 death (< 22 weeks) 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), 1999 Tomson (Phenobarbital), 2015 20.67[0.06; 7.16]3321not evaluable Late intrauterine deaths (> 22 weeks) 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 (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), 2001 Dean (Phenobarbital) (Controls unexposed, sick), 2007 Coste (Phenobarbital) (Controls unexposed, NOS), 2020 41.63[0.65; 4.08]10,030151not 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) (Controls unexposed, sick), 2008 Adams (Phenobarbital), 2022 Thomas (Phenobarbitone), 2022 32.93[1.39; 6.17]149not 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 Learning disorders Van der Pol (Phenobarbital) (Controls unexposed, sick), 1991 Elkjaer (Phenobarbital), 2018 23.12[0.30; 32.23]761not 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 Cognitive developmental disorders/delay (< 3 years old) Kelly (Phenobarbital), 1984 Thomas b (Phenobarbital), 2008 20.70[0.27; 1.84]2454not evaluable Psychomotor developmental disorders/delay Koch (Phenobarbital), 1996 Thomas b (Phenobarbital), 2008 20.56[0.20; 1.61]2045not evaluable Severe cognitive developmental delay (Mental retardation) (> 6 years old) Titze (Phenobarbital) (Controls unexposed, sick), 2008 11.53[0.05; 49.80]13not evaluable0.0100.01.0