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Oxcarbazepine (All indications)
Overall results
Study description
Excluded studies
Table
Graphic
auto
during pregnancy (anytime or not specified)
1st trimester
2nd trimester
3rd trimester
2nd and/or 3rd trimester
throughout pregnancy
early pregnancy
days before delivery
late pregnancy
preconception-only
periconceptional
preconceptional for kinetic reason
at least 1st trimester
3 months (or more) before pregnancy or during pregnancy
1st and 2nd trimester
3 months or more before pregnancy or1st trimester
Whatever the period exposition
individual studies
Outcome
TE
95% CI
n cases
n exposed
k
Pub. 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
15
1.51
[
1.21
; 1.88]
197,792
2,270
probable
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
13
1.52
[
1.22
; 1.89]
197,765
2,167
critical
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
4
12.20
[
2.32
; 64.13]
619
297
not evaluable
Congenital heart defects
Artama (Oxcarbazepine), 2005 Morrow (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2006 Tomson (Oxcarbazepine), 2018 Thomas (Oxcarbazepine) (Controls unexposed, sick), 2021
4
1.93
[
0.87
; 4.24]
42
510
not 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
4
4.48
[
1.11
; 18.10]
2,821
536
not 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
3
4.64
[
0.73
; 29.40]
1,639
240
not evaluable
Hypospadias
Morrow (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2006 Tomson (Oxcarbazepine), 2018 Blotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019
3
2.01
[
0.38
; 10.55]
3,383
479
not evaluable
Limb defects
Artama (Oxcarbazepine), 2005 Morrow (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2006 Thomas (Oxcarbazepine) (Controls unexposed, sick), 2021
3
2.81
[
0.46
; 17.19]
12
177
not evaluable
Urinary malformations
Artama (Oxcarbazepine), 2005 Tomson (Oxcarbazepine), 2018 Thomas (Oxcarbazepine) (Controls unexposed, sick), 2021
3
0.92
[
0.20
; 4.14]
16
503
not evaluable
Cleft palate
Viinikainen (Oxcarbazepine) (Controls unexposed, sick) a, 2006 Blotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019
2
9.82
[
0.96
; 100.29]
1,178
141
not evaluable
Digestive system anomalies
Morrow (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2006 Thomas (Oxcarbazepine) (Controls unexposed, sick), 2021
2
5.01
[
0.55
; 45.94]
4
78
not evaluable
Ano-rectal atresia and stenosis
Blotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019
1
12.43
[
0.77
; 200.03]
544
139
not evaluable
Atrial septal defect
Blotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019
1
4.10
[
0.27
; 62.58]
3,269
139
not evaluable
Atrioventricular septal defect
Blotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019
1
12.79
[
0.79
; 205.70]
529
139
not evaluable
Bilateral renal agenesis including Potter syndrome
Blotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019
1
89.69
[
5.53
; 1454.36]
75
139
not evaluable
Bladder exstrophy and/or epispadia
Blotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019
1
82.08
[
5.07
; 1329.93]
82
139
not evaluable
Club foot / Talipes equinovarus
Blotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019
1
4.03
[
0.25
; 64.83]
1,677
139
not evaluable
Coarctation of aorta
Blotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019
1
8.68
[
0.54
; 139.65]
779
139
not evaluable
Craniosynostosis
Blotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019
1
8.83
[
0.55
; 142.03]
766
139
not evaluable
Diaphragmatic hernia
Blotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019
1
17.89
[
1.11
; 287.94]
378
139
not evaluable
Ebstein's anomaly
Blotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019
1
Out of scale
134.09
[
8.23
; 2184.22]
50
139
not evaluable
Gastroschisis
Blotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019
1
27.81
[
1.73
; 448.07]
243
139
not evaluable
Hypoplastic left heart (HLH/HLHS)
Blotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019
1
31.27
[
1.94
; 504.13]
216
139
not evaluable
Hypoplastic right heart (HRH/HRHS)
Blotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019
1
Out of scale
101.82
[
6.27
; 1653.25]
66
139
not evaluable
Microcephaly / Small head circumference for gestational age
Blotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019
1
15.44
[
0.96
; 248.47]
438
139
not evaluable
Nervous system anomalies
Thomas (Oxcarbazepine) (Controls unexposed, sick), 2021
1
4.82
[
0.09
; 244.75]
-
71
not evaluable
Neural Tube Defects
Morrow (Oxcarbazepine) (Controls exposed to Lamotrigine, sick), 2006 Tomson (Oxcarbazepine), 2018
2
8.87
[
0.71
; 110.59]
2
340
not evaluable
Oesophageal atresia with or without tracheo-oesophageal fistula
Blotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019
1
17.25
[
1.07
; 277.65]
392
139
not evaluable
Omphalocele
Blotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019
1
25.41
[
1.58
; 409.29]
266
139
not evaluable
Polydactyly
Viinikainen (Oxcarbazepine) (Controls unexposed, sick) a, 2006 Tomson (Oxcarbazepine), 2018
2
26.41
[
2.05
; 340.38]
1
335
not evaluable
Pulmonary valve atresia
Blotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019
1
44.40
[
2.75
; 716.69]
152
139
not evaluable
Tetralogy of Fallot
Blotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019
1
11.58
[
0.72
; 186.32]
584
139
not evaluable
Ventricular septal defect
Blotière (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019
1
1.45
[
0.09
; 23.38]
4,643
139
not evaluable
Chromosomal abnormalities
Artama (Oxcarbazepine), 2005
1
9.53
[
0.19
; 482.86]
-
99
not evaluable
Ear, face and neck anomalies
Artama (Oxcarbazepine), 2005
1
1.90
[
0.09
; 39.89]
2
99
not evaluable
Eye defects
Artama (Oxcarbazepine), 2005
1
3.17
[
0.13
; 78.41]
1
99
not evaluable
Genital anomalies
Artama (Oxcarbazepine), 2005
1
1.91
[
0.22
; 16.48]
6
99
not 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
6
1.07
[
0.94
; 1.21]
252,570
2,097
not 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
7
1.28
[
1.04
; 1.58]
209,798
3,553
not 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
3
1.25
[
0.93
; 1.68]
91,817
977
not evaluable
Large for gestational age (weight)
Artama (Oxcarbazepine) (Controls unexposed, sick), 2013 Aydin (Oxcarbazepine) (Controls unexposed, sick), 2020
2
0.78
[
0.26
; 2.30]
86
531
not evaluable
Macrosomia (> 4000g)
Coste (Oxcarbazepine) (Controls unexposed, NOS), 2020
1
0.79
[
0.55
; 1.13]
577,138
143
not evaluable
Very preterm (28 to 32 weeks)
Coste (Oxcarbazepine) (Controls unexposed, NOS), 2020
1
0.70
[
0.04
; 11.18]
8,584
143
not evaluable
Extremely preterm (< 28 weeks)
Coste (Oxcarbazepine) (Controls unexposed, NOS), 2020
1
5.89
[
0.82
; 42.16]
2,042
143
not evaluable
Maternal consequences
Preeclampsia
Cohen (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019 Aydin (Oxcarbazepine) (Controls unexposed, sick), 2020
2
1.12
[
0.86
; 1.45]
53,690
1,113
not evaluable
Caesarean
Artama (Oxcarbazepine) (Controls unexposed, sick), 2013
1
0.98
[
0.76
; 1.27]
430
532
not evaluable
Abruptio placentae (retroplacental hematoma)
Cohen (Oxcarbazepine) (Controls unexposed NOS) (Mixed indications), 2019
1
0.92
[
0.57
; 1.50]
20,286
1,109
not evaluable
Amniotic fluid problems (polyhydramnios and/or oligohydramnios)
Aydin (Oxcarbazepine) (Controls unexposed, sick), 2020
1
6.14
[
0.10
; 363.16]
-
4
not evaluable
Gestational diabetes
Aydin (Oxcarbazepine) (Controls unexposed, sick), 2020
1
1.95
[
0.07
; 58.24]
1
4
not 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
4
2.02
[
0.48
; 8.47]
2,031
475
not evaluable
Low Apgar score (< 7) (at 1 min)
Artama (Oxcarbazepine) (Controls unexposed, sick), 2013 Bank (Oxcarbazepine) (Mixed indications), 2017
2
1.34
[
0.84
; 2.13]
98
469
not evaluable
Low Apgar score (< 7) (at 5 min)
Artama (Oxcarbazepine) (Controls unexposed, sick), 2013 Bank (Oxcarbazepine) (Mixed indications), 2017
2
1.35
[
0.14
; 12.85]
5
234
not evaluable
Neonatal disorders (as a whole)
Coste (Oxcarbazepine) (Controls unexposed, NOS), 2020
1
0.90
[
0.54
; 1.50]
222,218
143
not evaluable
Long term consequences
Child/Infant death (> 28 days of life)
Artama (Oxcarbazepine) (Controls unexposed, sick), 2013 Coste (Oxcarbazepine) (Controls unexposed, NOS), 2020
2
1.87
[
0.52
; 6.65]
4,704
670
not evaluable
Behavioral disorders
Dreier (Oxcarbazepine) (Epilepsy) (Controls unexposed, sick), 2023
1
1.09
[
0.59
; 2.02]
130
1,460
not evaluable
Emotional disorders
Dreier (Oxcarbazepine) (Epilepsy) (Controls unexposed, sick), 2023
1
0.88
[
0.47
; 1.65]
83
1,460
not 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
3
3.13
[
0.62
; 15.80]
184
337
not evaluable
Late intrauterine deaths (> 22 weeks)
Tomson (Oxcarbazepine), 2015 AlSheikh (Oxcarbazepine) (Controls unexposed, sick), 2020 Aydin (Oxcarbazepine) (Controls unexposed, sick), 2020
3
2.79
[
0.68
; 11.38]
8
269
not evaluable
Perinatal death
Artama (Oxcarbazepine) (Controls unexposed, sick), 2013 Tomson (Oxcarbazepine), 2015
2
2.56
[
0.96
; 6.84]
20
772
not evaluable
Elective/induced termination of pregnancy
Hosny (Oxcarbazepine) (Controls unexposed, sick), 2021
1
8.20
[
0.13
; 511.93]
-
3
not evaluable
Early intrauterine death (< 22 weeks)
Tomson (Oxcarbazepine), 2015
1
1.01
[
0.62
; 1.65]
164
262
not 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
5
1.63
[
1.22
; 2.17]
43,043
3,119
not evaluable
Language disorders/delay
Videman (Oxcarbazepine) (Controls unexposed, disease free), 2016 Coste (Oxcarbazepine) (Controls unexposed, NOS), 2020 Meador (Oxcarbazepine) (Controls unexposed, disease free), 2021
3
2.52
[
0.94
; 6.73]
72,025
166
not evaluable
ASD (Autism spectrum disorder): Diagnosis
Coste (Oxcarbazepine) (Controls unexposed, NOS), 2020 Bjørk (Oxcarbazepine) (Controls unexposed, sick), 2022
2
1.35
[
0.85
; 2.13]
4,539
1,572
not evaluable
Cognitive developmental disorders/delay (> 6 years old)
Bjørk (Oxcarbazepine) (Controls unexposed, sick), 2022
1
0.87
[
0.48
; 1.58]
130
1,429
not evaluable
Neuro-developmental disorders (as a whole)
Coste (Oxcarbazepine) (Controls unexposed, NOS), 2020 Bjørk (Oxcarbazepine) (Controls unexposed, sick), 2022
2
0.96
[
0.68
; 1.36]
10,445
1,572
not evaluable
Severe cognitive developmental delay (Mental retardation) (> 6 years old)
Bjørk (Oxcarbazepine) (Controls unexposed, sick), 2022
1
0.87
[
0.48
; 1.58]
130
1,429
not evaluable
ADHD (Attention deficit hyperactivity disorder): Diagnosis
Dreier (Oxcarbazepine) (Epilepsy) (Controls unexposed, sick), 2023
1
0.99
[
0.70
; 1.40]
580
1,460
not evaluable
ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk
Dreier (Oxcarbazepine) (Epilepsy) (Controls unexposed, sick), 2023
1
0.99
[
0.70
; 1.40]
580
1,460
not evaluable
ASD (Autism spectrum disorder): Risk
Bjørk (Oxcarbazepine) (Controls unexposed, sick), 2018
1
1.27
[
0.06
; 25.24]
27
4
not evaluable
Cognitive developmental disorders/delay (3-6 years old)
Coste (Oxcarbazepine) (Controls unexposed, NOS), 2020
1
1.76
[
0.11
; 28.32]
3,398
143
not evaluable
Severe cognitive developmental delay (Mental retardation) (3-6 years old)
Coste (Oxcarbazepine) (Controls unexposed, NOS), 2020
1
1.76
[
0.11
; 28.32]
3,398
143
not evaluable
Childhood autism (F84.0)
Christensen (Oxcarbazepine) (Controls unexposed NOS) (Indications NOS), 2013
1
1.00
[
0.12
; 8.31]
2,065
321
not evaluable
Cognitive developmental disorders/delay (< 3 years old)
Videman (Oxcarbazepine) (Controls unexposed, disease free), 2016
1
5.76
[
1.65
; 20.13]
-
10
not evaluable
Psychomotor developmental disorders/delay
Videman (Oxcarbazepine) (Controls unexposed, disease free), 2016
1
2.33
[
0.69
; 7.90]
-
10
not evaluable
Learning disorders
Elkjaer (Oxcarbazepine), 2018
1
1.06
[
1.01
; 1.12]
-
124
not evaluable
0.0
100.0
1.0