Phenytoin (Epilepsy)

Table   Graphic  
individual studies
OutcomeTE95% CIn casesn exposedkPub. bias Congenital malformations All congenital malformations (majors, minors, majors and minors, or unspecified) Lowe (Phenytoin) (Controls unexposed, sick), 1973 D'Souza (Phenytoin) (Controls unexposed, sick), 1991 Samrén (Phenytoin), 1999 Canger (Phenytoin), 1999 Kaneko (Phenytoin), 1999 Hvas (Phenytoin) (Controls unexposed, sick), 2000 Dean (Phenytoin), 2002 Kaaja (Phenytoin), 2003 Artama (Phenytoin), 2005 Morrow (Phenytoin) (Controls unexposed, sick), 2006 Viinikainen (Phenytoin) (Controls unexposed, sick) a, 2006 Mawer (Phenytoin) (Controls unexposed, sick), 2010 Bànhidy (Phenytoin), 2011 Hernández-Díaz (Phenytoin) (Controls unexposed, disease free), 2012 Arteaga-Vázquez (Phenytoin), 2012 Tomson (Phenytoin), 2018 Vajda (Phenytoin) (Controls unexposed, sick), 2019 Aydin (Phenytoin) (Controls unexposed, sick), 2020 Thomas (Phenytoin) (Controls unexposed, sick), 2021 192.13[1.41; 3.22]3161,405probable Major congenital malformations Canger (Phenytoin), 1999 Samrén (Phenytoin), 1999 Hvas (Phenytoin) (Controls unexposed, sick), 2000 Dean (Phenytoin), 2002 Kaaja (Phenytoin), 2003 Viinikainen (Phenytoin) (Controls unexposed, sick) a, 2006 Morrow (Phenytoin) (Controls unexposed, sick), 2006 Mawer (Phenytoin) (Controls unexposed, sick), 2010 Bànhidy (Phenytoin), 2011 Hernández-Díaz (Phenytoin) (Controls unexposed, disease free), 2012 Tomson (Phenytoin), 2018 Vajda (Phenytoin) (Controls unexposed, sick), 2019 Thomas (Phenytoin) (Controls unexposed, sick), 2021 131.57[0.99; 2.48]2071,160low Congenital heart defects D'Souza (Phenytoin) (Controls unexposed, sick), 1991 Artama (Phenytoin), 2005 Morrow (Phenytoin) (Controls exposed to Lamotrigine, sick), 2006 Mawer (Phenytoin) (Controls unexposed, sick), 2010 Bànhidy (Phenytoin), 2011 Hernández-Díaz (Phenytoin) (Controls exposed to Lamotrigine, sick), 2012 Vajda (Phenytoin) (Controls unexposed, sick), 2013 Tomson (Phenytoin), 2018 Thomas (Phenytoin) (Controls unexposed, sick), 2021 92.10[0.93; 4.72]65875not evaluable Limb defects Artama (Phenytoin), 2005 Morrow (Phenytoin) (Controls exposed to Lamotrigine, sick), 2006 Mawer (Phenytoin) (Controls unexposed, sick), 2010 Vajda (Phenytoin) (Controls unexposed, sick), 2013 Thomas (Phenytoin) (Controls unexposed, sick), 2021 52.20[0.64; 7.52]14290not evaluable Neural Tube Defects Morrow (Phenytoin) (Controls exposed to Lamotrigine, sick), 2006 Mawer (Phenytoin) (Controls unexposed, sick), 2010 Bànhidy (Phenytoin), 2011 Hernández-Díaz (Phenytoin) (Controls exposed to Lamotrigine, sick), 2012 Vajda (Phenytoin) (Controls unexposed, sick), 2013 Tomson (Phenytoin), 2018 63.20[0.89; 11.45]8694not evaluable Cleft lip with or without cleft palate Lowe (Phenytoin) (Controls unexposed, sick), 1973 Artama (Phenytoin), 2005 Viinikainen (Phenytoin) (Controls unexposed, sick) a, 2006 Bànhidy (Phenytoin), 2011 Vajda (Phenytoin) (Controls unexposed, sick), 2013 55.45[1.08; 27.47]3113not evaluable Hypospadias D'Souza (Phenytoin) (Controls unexposed, sick), 1991 Morrow (Phenytoin) (Controls exposed to Lamotrigine, sick), 2006 Bànhidy (Phenytoin), 2011 Hernández-Díaz (Phenytoin) (Controls exposed to Lamotrigine, sick), 2012 Tomson (Phenytoin), 2018 50.75[0.22; 2.57]18666serious Microcephaly / Small head circumference for gestational age Kelly (Phenytoin), 1984 Battino (Phenytoin), 1999 Díaz-Romero (Phenytoin), 1999 Holmes (Phenytoin) (Controls unexposed, sick), 2001 Pennell (Phenytoin), 2012 50.69[0.30; 1.60]24297not evaluable Polydactyly D'Souza (Phenytoin) (Controls unexposed, sick), 1991 Viinikainen (Phenytoin) (Controls unexposed, sick) a, 2006 Bànhidy (Phenytoin), 2011 Tomson (Phenytoin), 2018 42.31[0.16; 33.73]3168not evaluable Spina bifida Czeizel (Phenytoin), 1992 Artama (Phenytoin), 2005 Viinikainen (Phenytoin) (Controls unexposed, sick) a, 2006 Vajda (Phenytoin) (Controls unexposed, sick), 2013 43.70[0.29; 47.79]2101not evaluable Urinary malformations Artama (Phenytoin), 2005 Tomson (Phenytoin), 2018 Thomas (Phenytoin) (Controls unexposed, sick), 2021 31.17[0.16; 8.76]15282not evaluable Digestive system anomalies Morrow (Phenytoin) (Controls exposed to Lamotrigine, sick), 2006 Thomas (Phenytoin) (Controls unexposed, sick), 2021 21.88[0.29; 12.03]5201not evaluable Minor congenital malformations Battino (Phenytoin), 1992 Wide (Phenytoin), 2000 Dean (Phenytoin), 2002 31.90[0.62; 5.84]2973not evaluable Oro-facial clefts Morrow (Phenytoin) (Controls exposed to Lamotrigine, sick), 2006 Hernández-Díaz (Phenytoin) (Controls exposed to Lamotrigine, sick), 2012 Tomson (Phenytoin), 2018 31.91[0.55; 6.62]14623not evaluable Cleft palate Viinikainen (Phenytoin) (Controls unexposed, sick) a, 2006 Bànhidy (Phenytoin), 2011 25.39[0.27; 106.61]122not evaluable Craniosynostosis D'Souza (Phenytoin) (Controls unexposed, sick), 1991 11.92[0.08; 44.92]222not evaluable Down syndrom / Trisomy 21 D'Souza (Phenytoin) (Controls unexposed, sick), 1991 11.10[0.04; 30.00]122not evaluable Eye defects Dean (Phenytoin), 2002 Artama (Phenytoin), 2005 21.75[0.31; 9.77]1162not evaluable Hip dislocation and/or dysplasia D'Souza (Phenytoin) (Controls unexposed, sick), 1991 11.10[0.04; 30.00]122not evaluable Nervous system anomalies Thomas (Phenytoin) (Controls unexposed, sick), 2021 18.67[0.35; 214.26]1119not evaluable Chromosomal abnormalities Artama (Phenytoin), 2005 125.03[0.49; 1278.58]-38not evaluable Club foot / Talipes equinovarus Bànhidy (Phenytoin), 2011 11.54[0.06; 41.56]120not evaluable Ear, face and neck anomalies Artama (Phenytoin), 2005 14.99[0.24; 105.88]238not evaluable Genital anomalies Artama (Phenytoin), 2005 12.26[0.12; 41.69]538not evaluable Growth parameters and prematurity Preterm (< 37 weeks) Koch (Phenytoin), 1996 Pennell (Phenytoin), 2012 Artama (Phenytoin) (Controls unexposed, sick), 2013 Arkilo (Phenytoin), 2015 Aydin (Phenytoin) (Controls unexposed, sick), 2020 52.11[0.93; 4.81]107100not evaluable Small for gestational age (weight) Wide (Phenytoin), 2000 Pennell (Phenytoin), 2012 Artama (Phenytoin) (Controls unexposed, sick), 2013 Aydin (Phenytoin) (Controls unexposed, sick), 2020 40.91[0.23; 3.59]48104not evaluable Large for gestational age (weight) Artama (Phenytoin) (Controls unexposed, sick), 2013 Aydin (Phenytoin) (Controls unexposed, sick), 2020 23.81[0.42; 34.93]7427not evaluable Low birth weight (< 2500g) Artama (Phenytoin) (Controls unexposed, sick), 2013 10.99[0.13; 7.60]6626not evaluable Large head circumference for gestational age Díaz-Romero (Phenytoin), 1999 10.37[0.01; 20.14]-21not evaluable Maternal consequences Caesarean Artama (Phenytoin) (Controls unexposed, sick), 2013 10.19[0.03; 1.30]33226not evaluable Gestational diabetes Pennell (Phenytoin), 2012 Aydin (Phenytoin) (Controls unexposed, sick), 2020 22.30[0.67; 7.91]1153not evaluable Preeclampsia Pennell (Phenytoin), 2012 Aydin (Phenytoin) (Controls unexposed, sick), 2020 23.28[0.13; 84.58]853not evaluable Amniotic fluid problems (polyhydramnios and/or oligohydramnios) Aydin (Phenytoin) (Controls unexposed, sick), 2020 143.00[0.35; 5328.22]-1not evaluable Neonatal disorders Neonatal medical care D'Souza (Phenytoin) (Controls unexposed, sick), 1991 Viinikainen (Phenytoin) (Controls unexposed, disease free) a, 2006 Artama (Phenytoin) (Controls unexposed, sick), 2013 Aydin (Phenytoin) (Controls unexposed, sick), 2020 41.37[0.26; 7.15]1,97846not evaluable Low Apgar score (< 7) (at 1 min) Pennell (Phenytoin), 2012 Artama (Phenytoin) (Controls unexposed, sick), 2013 22.56[0.32; 20.32]8374not evaluable Low Apgar score (< 7) (at 5 min) Pennell (Phenytoin), 2012 Artama (Phenytoin) (Controls unexposed, sick), 2013 222.18[2.31; 213.27]555not evaluable Feeding difficulty D'Souza (Phenytoin) (Controls unexposed, sick), 1991 Yerby (Phenytoin), 1992 21.79[0.18; 18.25]234not evaluable Jaundice D'Souza (Phenytoin) (Controls unexposed, sick), 1991 10.70[0.05; 8.97]322not evaluable Neonatal disorders (as a whole) D'Souza (Phenytoin) (Controls unexposed, sick), 1991 13.00[0.49; 18.25]1322not evaluable Neonatal hypotonia D'Souza (Phenytoin) (Controls unexposed, sick), 1991 11.92[0.08; 44.92]222not evaluable Neonatal infections D'Souza (Phenytoin) (Controls unexposed, sick), 1991 11.10[0.04; 30.00]122not evaluable Neonatal intracranial hemorrhage D'Souza (Phenytoin) (Controls unexposed, sick), 1991 11.10[0.04; 30.00]122not evaluable Neonatal tachypnea D'Souza (Phenytoin) (Controls unexposed, sick), 1991 10.35[0.01; 19.18]-22not evaluable Withdrawal syndrome / Neonatal abstinence syndrome / Poor neonatal adaptation 0----- Long term consequences Child/Infant death (> 28 days of life) Artama (Phenytoin) (Controls unexposed, sick), 2013 16.37[0.34; 118.32]526not evaluable Behavioral disorders Cohen (Phenytoin), 2013 10.80[0.37; 1.74]-31not evaluable Child/Infant growth abnormalities (> 1 year) Pennell (Phenytoin), 2012 10.74[0.17; 3.12]945not evaluable Child/Infant head circumference abnormalities (> 1 year) Pennell (Phenytoin), 2012 14.48[0.18; 112.88]140not evaluable Emotional disorders Cohen (Phenytoin), 2013 11.72[0.78; 3.79]-31not evaluable Intrauterine deaths Intrauterine deaths (as a whole or unspecified) Meador (Phenytoin), 2006 Arkilo (Phenytoin), 2015 Miškov (Phenytoin) (Controls unexposed, sick), 2016 Vajda (Phenytoin) (Controls unexposed, sick), 2018 Trivedi (Phenytoin) (Controls unexposed, sick), 2018 54.81[1.66; 13.92]21233not evaluable Early intrauterine death (< 22 weeks) Arkilo (Phenytoin), 2015 Miškov (Phenytoin) (Controls unexposed, sick), 2016 21.73[0.12; 25.30]26not evaluable Perinatal death Canger (Phenytoin), 1999 Artama (Phenytoin) (Controls unexposed, sick), 2013 22.05[0.20; 20.82]1057not evaluable Elective/induced termination of pregnancy Miškov (Phenytoin) (Controls unexposed, sick), 2016 17.00[0.05; 953.26]-1not evaluable Late intrauterine deaths (> 22 weeks) Arkilo (Phenytoin), 2015 Aydin (Phenytoin) (Controls unexposed, sick), 2020 212.49[0.56; 277.13]-6not evaluable Therapeutic terminations of pregnancy Miškov (Phenytoin) (Controls unexposed, sick), 2016 17.00[0.05; 953.26]-1not evaluable Neuro-developmental disorders Cognitive developmental disorders/delay (> 6 years old) Adab (Phenytoin), 2004 Titze (Phenytoin) (Controls unexposed, sick), 2008 Meador (Phenytoin), 2013 Adams (Phenytoin), 2022 Thomas (Phenytoin), 2022 51.11[0.49; 2.53]5123not evaluable Language disorders/delay Vinten (Phenytoin), 2005 Meador (Phenytoin), 2013 Thomas (Phenytoin), 2022 Adams (Phenytoin), 2022 40.99[0.61; 1.63]6111not evaluable Neuro-developmental disorders (as a whole) Katz (Phenytoin), 2001 Adab (Phenytoin), 2004 Dean (Phenytoin) (Controls unexposed, sick), 2007 Arkilo (Phenytoin), 2015 42.37[0.65; 8.62]5157not evaluable Cognitive developmental disorders/delay (< 3 years old) Kelly (Phenytoin), 1984 Wide (Phenytoin), 2000 Thomas b (Phenytoin), 2008 Meador (Phenytoin), 2013 41.17[0.40; 3.49]52133not evaluable ASD (Autism spectrum disorder): Diagnosis Bromley (Phenytoin) (Controls unexposed, sick), 2008 118.60[0.69; 500.42]19not evaluable ASD (Autism spectrum disorder): Diagnosis/Risk Bromley (Phenytoin) (Controls unexposed, sick), 2008 118.60[0.69; 500.42]19not evaluable Psychomotor developmental disorders/delay Koch (Phenytoin), 1996 Thomas b (Phenytoin), 2008 Cohen (Phenytoin), 2011 30.60[0.32; 1.12]1971not evaluable Severe cognitive developmental delay (Mental retardation) (> 6 years old) Titze (Phenytoin) (Controls unexposed, sick), 2008 Meador (Phenytoin), 2013 20.68[0.05; 8.52]152not evaluable Learning disorders Forsberg (Phenytoin) (Controls unexposed, sick), 2011 10.88[0.53; 1.47]76288not evaluable ADHD (Attention deficit hyperactivity disorder): Diagnosis Cohen (Phenytoin), 2013 10.42[0.04; 4.11]517not evaluable ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk Cohen (Phenytoin), 2013 10.42[0.04; 4.11]517not evaluable ADHD (Attention deficit hyperactivity disorder): Risk Cohen (Phenytoin), 2013 10.53[0.10; 2.73]931not evaluable Cognitive developmental disorders/delay (3-6 years old) Meador (Phenytoin), 2013 11.15[0.30; 4.31]1043not evaluable Severe cognitive developmental delay (Mental retardation) (< 3 years old) Meador (Phenytoin), 2013 11.40[0.40; 4.90]1142not evaluable Severe cognitive developmental delay (Mental retardation) (3-6 years old) Meador (Phenytoin), 2013 11.71[0.03; 87.56]-43not evaluable0.0100.01.0

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