Oxcarbazepine (All indications)

Table   Graphic  
individual studies
OutcomeTE95% CIn casesn exposedkPub. bias Congenital malformations All congenital malformations (majors, minors, majors and minors, or unspecified) Samrén (Oxcarbazepine), 1999 Hvas (Oxcarbazepine) (Controls unexposed, sick), 2000 Kaaja (Oxcarbazepine), 2003 Artama (Oxcarbazepine), 2005 Viinikainen (Oxcarbazepine) (Controls unexposed, sick) a, 2006 Morrow (Oxcarbazepine) (Controls unexposed, sick), 2006 Källén (Oxcarbazepine) (Controls unexposed, NOS) (Indications NOS), 2013 Veiby (Oxcarbazepine) (Controls unexposed, sick) (Mixed indications), 2014 Tomson (Oxcarbazepine), 2018 Vajda (Oxcarbazepine) (Controls unexposed, sick), 2019 Aydin (Oxcarbazepine) (Controls unexposed, sick), 2020 Thomas (Oxcarbazepine) (Controls unexposed, sick), 2021 Hosny (Oxcarbazepine) (Controls unexposed, sick), 2021 The NAAED (Controls unexposed, disease free) (Indications NOS), 2022 Cohen (Oxcarbazepine) (Epilepsy) (Controls unexposed, NOS), 2023 151.51[1.21; 1.88]197,7922,270probable Major congenital malformations Samrén (Oxcarbazepine), 1999 Hvas (Oxcarbazepine) (Controls unexposed, sick), 2000 Kaaja (Oxcarbazepine), 2003 Morrow (Oxcarbazepine) (Controls unexposed, sick), 2006 Viinikainen (Oxcarbazepine) (Controls unexposed, sick) a, 2006 Källén (Oxcarbazepine) (Controls unexposed, NOS) (Indications NOS), 2013 Veiby (Oxcarbazepine) (Controls unexposed, sick) (Mixed indications), 2014 Tomson (Oxcarbazepine), 2018 Vajda (Oxcarbazepine) (Controls unexposed, sick), 2019 Thomas (Oxcarbazepine) (Controls unexposed, sick), 2021 Hosny (Oxcarbazepine) (Controls unexposed, sick), 2021 The NAAED (Controls unexposed, disease free) (Indications NOS), 2022 Cohen (Oxcarbazepine) (Epilepsy) (Controls unexposed, NOS), 2023 131.52[1.22; 1.89]197,7652,167critical Spina bifida Artama (Oxcarbazepine), 2005 Viinikainen (Oxcarbazepine) (Controls unexposed, sick) a, 2006 Veiby (Oxcarbazepine) (Controls unexposed, sick) (Mixed indications), 2014 Blotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019 412.20[2.32; 64.13]619297not evaluable Congenital heart defects Artama (Oxcarbazepine), 2005 Morrow (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2006 Tomson (Oxcarbazepine), 2018 Thomas (Oxcarbazepine) (Controls unexposed, sick), 2021 41.93[0.87; 4.24]42510not evaluable Oro-facial clefts Morrow (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2006 Veiby (Oxcarbazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 Tomson (Oxcarbazepine), 2018 Blotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019 44.48[1.11; 18.10]2,821536not evaluable Cleft lip with or without cleft palate Artama (Oxcarbazepine), 2005 Viinikainen (Oxcarbazepine) (Controls unexposed, sick) a, 2006 Blotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019 34.64[0.73; 29.40]1,639240not evaluable Hypospadias Morrow (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2006 Tomson (Oxcarbazepine), 2018 Blotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019 32.01[0.38; 10.55]3,383479not evaluable Limb defects Artama (Oxcarbazepine), 2005 Morrow (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2006 Thomas (Oxcarbazepine) (Controls unexposed, sick), 2021 32.81[0.46; 17.19]12177not evaluable Urinary malformations Artama (Oxcarbazepine), 2005 Tomson (Oxcarbazepine), 2018 Thomas (Oxcarbazepine) (Controls unexposed, sick), 2021 30.92[0.20; 4.14]16503not evaluable Cleft palate Viinikainen (Oxcarbazepine) (Controls unexposed, sick) a, 2006 Blotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019 29.82[0.96; 100.29]1,178141not evaluable Digestive system anomalies Morrow (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2006 Thomas (Oxcarbazepine) (Controls unexposed, sick), 2021 25.01[0.55; 45.94]478not evaluable Ano-rectal atresia and stenosis Blotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019 112.43[0.77; 200.03]544139not evaluable Atrial septal defect Blotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019 14.10[0.27; 62.58]3,269139not evaluable Atrioventricular septal defect Blotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019 112.79[0.79; 205.70]529139not evaluable Bilateral renal agenesis including Potter syndrome Blotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019 189.69[5.53; 1454.36]75139not evaluable Bladder exstrophy and/or epispadia Blotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019 182.08[5.07; 1329.93]82139not evaluable Club foot / Talipes equinovarus Blotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019 14.03[0.25; 64.83]1,677139not evaluable Coarctation of aorta Blotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019 18.68[0.54; 139.65]779139not evaluable Craniosynostosis Blotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019 18.83[0.55; 142.03]766139not evaluable Diaphragmatic hernia Blotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019 117.89[1.11; 287.94]378139not evaluable Ebstein's anomaly Blotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019 1Out of scale134.09[8.23; 2184.22]50139not evaluable Gastroschisis Blotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019 127.81[1.73; 448.07]243139not evaluable Hypoplastic left heart (HLH/HLHS) Blotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019 131.27[1.94; 504.13]216139not evaluable Hypoplastic right heart (HRH/HRHS) Blotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019 1Out of scale101.82[6.27; 1653.25]66139not evaluable Microcephaly / Small head circumference for gestational age Blotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019 115.44[0.96; 248.47]438139not evaluable Nervous system anomalies Thomas (Oxcarbazepine) (Controls unexposed, sick), 2021 14.82[0.09; 244.75]-71not evaluable Neural Tube Defects Morrow (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2006 Tomson (Oxcarbazepine), 2018 28.87[0.71; 110.59]2340not evaluable Oesophageal atresia with or without tracheo-oesophageal fistula Blotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019 117.25[1.07; 277.65]392139not evaluable Omphalocele Blotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019 125.41[1.58; 409.29]266139not evaluable Polydactyly Viinikainen (Oxcarbazepine) (Controls unexposed, sick) a, 2006 Tomson (Oxcarbazepine), 2018 226.41[2.05; 340.38]1335not evaluable Pulmonary valve atresia Blotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019 144.40[2.75; 716.69]152139not evaluable Tetralogy of Fallot Blotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019 111.58[0.72; 186.32]584139not evaluable Ventricular septal defect Blotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019 11.45[0.09; 23.38]4,643139not evaluable Chromosomal abnormalities Artama (Oxcarbazepine), 2005 19.53[0.19; 482.86]-99not evaluable Ear, face and neck anomalies Artama (Oxcarbazepine), 2005 11.90[0.09; 39.89]299not evaluable Eye defects Artama (Oxcarbazepine), 2005 13.17[0.13; 78.41]199not evaluable Genital anomalies Artama (Oxcarbazepine), 2005 11.91[0.22; 16.48]699not evaluable Growth parameters and prematurity Preterm (< 37 weeks) Artama (Oxcarbazepine) (Controls unexposed, sick), 2013 Kilic (Oxcarbazepine) (Controls unexposed, sick) (Mixed indications), 2014 Bank (Oxcarbazepine) (Mixed indications), 2017 Cohen (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019 Coste (Oxcarbazepine) (Controls unexposed, NOS), 2020 Aydin (Oxcarbazepine) (Controls unexposed, sick), 2020 61.07[0.94; 1.21]252,5702,097not evaluable Small for gestational age (weight) Artama (Oxcarbazepine) (Controls unexposed, sick), 2013 Kilic (Oxcarbazepine) (Controls unexposed, sick) (Mixed indications), 2014 Bank (Oxcarbazepine) (Mixed indications), 2017 Cohen (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019 Coste (Oxcarbazepine) (Controls unexposed, NOS), 2020 Aydin (Oxcarbazepine) (Controls unexposed, sick), 2020 Dreier (Oxcarbazepine), 2021 71.28[1.04; 1.58]209,7983,553not evaluable Low birth weight (< 2500g) Artama (Oxcarbazepine) (Controls unexposed, sick), 2013 Kilic (Oxcarbazepine) (Controls unexposed, sick) (Mixed indications), 2014 Coste (Oxcarbazepine) (Controls unexposed, NOS), 2020 31.25[0.93; 1.68]91,817977not evaluable Large for gestational age (weight) Artama (Oxcarbazepine) (Controls unexposed, sick), 2013 Aydin (Oxcarbazepine) (Controls unexposed, sick), 2020 20.78[0.26; 2.30]86531not evaluable Macrosomia (> 4000g) Coste (Oxcarbazepine) (Controls unexposed, NOS), 2020 10.79[0.55; 1.13]577,138143not evaluable Very preterm (28 to 32 weeks) Coste (Oxcarbazepine) (Controls unexposed, NOS), 2020 10.70[0.04; 11.18]8,584143not evaluable Extremely preterm (< 28 weeks) Coste (Oxcarbazepine) (Controls unexposed, NOS), 2020 15.89[0.82; 42.16]2,042143not evaluable Maternal consequences Preeclampsia Cohen (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019 Aydin (Oxcarbazepine) (Controls unexposed, sick), 2020 21.12[0.86; 1.45]53,6901,113not evaluable Caesarean Artama (Oxcarbazepine) (Controls unexposed, sick), 2013 10.98[0.76; 1.27]430532not evaluable Abruptio placentae (retroplacental hematoma) Cohen (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019 10.92[0.57; 1.50]20,2861,109not evaluable Amniotic fluid problems (polyhydramnios and/or oligohydramnios) Aydin (Oxcarbazepine) (Controls unexposed, sick), 2020 16.14[0.10; 363.16]-4not evaluable Gestational diabetes Aydin (Oxcarbazepine) (Controls unexposed, sick), 2020 11.95[0.07; 58.24]14not evaluable Neonatal disorders Neonatal medical care Viinikainen (Oxcarbazepine) (Controls unexposed, disease free) a, 2006 Artama (Oxcarbazepine) (Controls unexposed, sick), 2013 Bank (Oxcarbazepine) (Mixed indications), 2017 Aydin (Oxcarbazepine) (Controls unexposed, sick), 2020 42.02[0.48; 8.47]2,031475not evaluable Low Apgar score (< 7) (at 1 min) Artama (Oxcarbazepine) (Controls unexposed, sick), 2013 Bank (Oxcarbazepine) (Mixed indications), 2017 21.34[0.84; 2.13]98469not evaluable Low Apgar score (< 7) (at 5 min) Artama (Oxcarbazepine) (Controls unexposed, sick), 2013 Bank (Oxcarbazepine) (Mixed indications), 2017 21.35[0.14; 12.85]5234not evaluable Neonatal disorders (as a whole) Coste (Oxcarbazepine) (Controls unexposed, NOS), 2020 10.90[0.54; 1.50]222,218143not evaluable Long term consequences Child/Infant death (> 28 days of life) Artama (Oxcarbazepine) (Controls unexposed, sick), 2013 Coste (Oxcarbazepine) (Controls unexposed, NOS), 2020 21.87[0.52; 6.65]4,704670not evaluable Behavioral disorders Dreier (Oxcarbazepine) (Epilepsy) (Controls unexposed, sick), 2023 11.09[0.59; 2.02]1301,460not evaluable Emotional disorders Dreier (Oxcarbazepine) (Epilepsy) (Controls unexposed, sick), 2023 10.88[0.47; 1.65]831,460not evaluable Intrauterine deaths Intrauterine deaths (as a whole or unspecified) Tomson (Oxcarbazepine), 2015 Trivedi (Oxcarbazepine) (Controls unexposed, sick), 2018 Vajda (Oxcarbazepine) (Controls unexposed, sick), 2018 33.13[0.62; 15.80]184337not evaluable Late intrauterine deaths (> 22 weeks) Tomson (Oxcarbazepine), 2015 AlSheikh (Oxcarbazepine) (Controls unexposed, sick), 2020 Aydin (Oxcarbazepine) (Controls unexposed, sick), 2020 32.79[0.68; 11.38]8269not evaluable Perinatal death Artama (Oxcarbazepine) (Controls unexposed, sick), 2013 Tomson (Oxcarbazepine), 2015 22.56[0.96; 6.84]20772not evaluable Elective/induced termination of pregnancy Hosny (Oxcarbazepine) (Controls unexposed, sick), 2021 18.20[0.13; 511.93]-3not evaluable Early intrauterine death (< 22 weeks) Tomson (Oxcarbazepine), 2015 11.01[0.62; 1.65]164262not evaluable Neuro-developmental disorders ASD (Autism spectrum disorder): Diagnosis/Risk Bjørk (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2018 Bjørk (Oxcarbazepine) (Controls unexposed, sick), 2018 Coste (Oxcarbazepine) (Controls unexposed, NOS), 2020 Bjørk (Oxcarbazepine) (Controls unexposed, sick), 2022 Bjørk (Oxcarbazepine) (Controls unexposed NOS), 2022 51.63[1.22; 2.17]43,0433,119not evaluable Language disorders/delay Videman (Oxcarbazepine) (Controls unexposed, disease free), 2016 Coste (Oxcarbazepine) (Controls unexposed, NOS), 2020 Meador (Oxcarbazepine) (Controls unexposed, disease free), 2021 32.52[0.94; 6.73]72,025166not evaluable ASD (Autism spectrum disorder): Diagnosis Coste (Oxcarbazepine) (Controls unexposed, NOS), 2020 Bjørk (Oxcarbazepine) (Controls unexposed, sick), 2022 21.35[0.85; 2.13]4,5391,572not evaluable Cognitive developmental disorders/delay (> 6 years old) Bjørk (Oxcarbazepine) (Controls unexposed, sick), 2022 10.87[0.48; 1.58]1301,429not evaluable Neuro-developmental disorders (as a whole) Coste (Oxcarbazepine) (Controls unexposed, NOS), 2020 Bjørk (Oxcarbazepine) (Controls unexposed, sick), 2022 20.96[0.68; 1.36]10,4451,572not evaluable Severe cognitive developmental delay (Mental retardation) (> 6 years old) Bjørk (Oxcarbazepine) (Controls unexposed, sick), 2022 10.87[0.48; 1.58]1301,429not evaluable ADHD (Attention deficit hyperactivity disorder): Diagnosis Dreier (Oxcarbazepine) (Epilepsy) (Controls unexposed, sick), 2023 10.99[0.70; 1.40]5801,460not evaluable ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk Dreier (Oxcarbazepine) (Epilepsy) (Controls unexposed, sick), 2023 10.99[0.70; 1.40]5801,460not evaluable ASD (Autism spectrum disorder): Risk Bjørk (Oxcarbazepine) (Controls unexposed, sick), 2018 11.27[0.06; 25.24]274not evaluable Cognitive developmental disorders/delay (3-6 years old) Coste (Oxcarbazepine) (Controls unexposed, NOS), 2020 11.76[0.11; 28.32]3,398143not evaluable Severe cognitive developmental delay (Mental retardation) (3-6 years old) Coste (Oxcarbazepine) (Controls unexposed, NOS), 2020 11.76[0.11; 28.32]3,398143not evaluable Childhood autism (F84.0) Christensen (Oxcarbazepine) (Controls unexposed NOS) (Indications NOS), 2013 11.00[0.12; 8.31]2,065321not evaluable Cognitive developmental disorders/delay (< 3 years old) Videman (Oxcarbazepine) (Controls unexposed, disease free), 2016 15.76[1.65; 20.13]-10not evaluable Psychomotor developmental disorders/delay Videman (Oxcarbazepine) (Controls unexposed, disease free), 2016 12.33[0.69; 7.90]-10not evaluable Learning disorders Elkjaer (Oxcarbazepine), 2018 11.06[1.01; 1.12]-124not evaluable0.0100.01.0

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