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Lamotrigine (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)
Mawer (Lamotrigine) (Controls unexposed, sick), 2010 Charlton (Lamotrigine), 2011 Källén (Lamotrigine) (Indications NOS), 2013 Rihtman (Lamotrigine), 2013 Cassina (Lamotrigine) (Mixed indications), 2013 Veiby (Lamotrigine) (Controls unexposed, sick) (Mixed indications), 2014 Campbell (Lamotrigine), 2014 Vanya (Lamotrigine) (Controls unexposed, sick), 2015 Petersen (Lamotrigine) (Controls unexposed, sick), 2017 Vajda (Lamotrigine), 2019 Meador (Lamotrigine) (Controls unexposed, sick), 2020 Aydin (Lamotrigine), 2020 Thomas (Lamotrigine) (Controls unexposed, sick), 2021 Hosny, 2021 The NAAED (Indications NOS), 2022 Cohen (Lamotrigine) (Mixed indications), 2023
16
1.01
[
0.92
; 1.11]
198,229
15,836
probable
Major congenital malformations
Mawer (Lamotrigine) (Controls unexposed, sick), 2010 Charlton (Lamotrigine), 2011 Cassina (Lamotrigine) (Mixed indications), 2013 Källén (Lamotrigine) (Indications NOS), 2013 Veiby (Lamotrigine) (Controls unexposed, sick) (Mixed indications), 2014 Campbell (Lamotrigine), 2014 Vanya (Lamotrigine) (Controls unexposed, sick), 2015 Petersen (Lamotrigine) (Controls unexposed, sick), 2017 Diav-Citrin (Lamotrigine), 2017 Vajda (Lamotrigine), 2019 Meador (Lamotrigine) (Controls unexposed, sick), 2020 Hosny, 2021 Thomas (Lamotrigine) (Controls unexposed, sick), 2021 The NAAED (Indications NOS), 2022 Cohen (Lamotrigine) (Mixed indications), 2023
15
1.02
[
0.92
; 1.12]
198,255
15,901
probable
Congenital heart defects
Mawer (Lamotrigine) (Controls unexposed, sick), 2010 Vajda (Lamotrigine), 2013 Källén (Lamotrigine) (Indications NOS), 2013 Ban (Lamotrigine) (Mixed indications), 2015 Diav-Citrin (Lamotrigine), 2017 Thomas (Lamotrigine) (Controls unexposed, sick), 2021 Cohen (Lamotrigine) (Mixed indications), 2023
7
1.16
[
0.78
; 1.71]
18,229
10,212
not evaluable
Limb defects
Mawer (Lamotrigine) (Controls unexposed, sick), 2010 Vajda (Lamotrigine), 2013 Ban (Lamotrigine) (Mixed indications), 2015 Thomas (Lamotrigine) (Controls unexposed, sick), 2021
4
1.24
[
0.41
; 3.76]
1,269
675
not evaluable
Oro-facial clefts
Holmes (Lamotrigine), 2008 Källén (Lamotrigine) (Indications NOS), 2013 Dolk (Lamotrigine) (Mixed indications), 2016 Blotière (Lamotrigine) (Mixed indications), 2019 Cohen (Lamotrigine) (Mixed indications), 2023
5
1.85
[
0.77
; 4.43]
5,729
13,104
not evaluable
Club foot / Talipes equinovarus
Källén (Lamotrigine) (Indications NOS), 2013 Dolk (Lamotrigine) (Mixed indications), 2016 Blotière (Lamotrigine) (Mixed indications), 2019 Cohen (Lamotrigine) (Mixed indications), 2023
4
1.12
[
0.80
; 1.57]
3,807
12,420
not evaluable
Hypospadias
Källén (Lamotrigine) (Indications NOS), 2013 Veiby (Lamotrigine) (Controls unexposed, disease free) (Mixed indications), 2014 Blotière (Lamotrigine) (Mixed indications), 2019 Cohen (Lamotrigine) (Mixed indications), 2023
4
1.14
[
0.82
; 1.59]
9,480
13,253
not evaluable
Cleft palate
Holmes (Lamotrigine), 2008 Dolk (Lamotrigine) (Mixed indications), 2016 Blotière (Lamotrigine) (Mixed indications), 2019
3
3.22
[
0.42
; 25.01]
1,226
3,681
not evaluable
Nervous system anomalies
Ban (Lamotrigine) (Mixed indications), 2015 Thomas (Lamotrigine) (Controls unexposed, sick), 2021 Cohen (Lamotrigine) (Mixed indications), 2023
3
1.44
[
0.90
; 2.29]
367
8,662
not evaluable
Neural Tube Defects
Mawer (Lamotrigine) (Controls unexposed, sick), 2010 Vajda (Lamotrigine), 2013
2
0.72
[
0.04
; 11.59]
-
352
not evaluable
Spina bifida
Charlton (Lamotrigine), 2011 Veiby (Lamotrigine) (Controls unexposed, sick) (Mixed indications), 2014 Blotière (Lamotrigine) (Mixed indications), 2019
3
1.04
[
0.25
; 4.41]
622
3,928
not evaluable
Cardiac septal defects
Källén (Lamotrigine) (Indications NOS), 2013 Veiby (Lamotrigine) (Controls unexposed, disease free) (Mixed indications), 2014
2
1.46
[
0.94
; 2.26]
16,577
1,917
not evaluable
Cleft lip with or without cleft palate
Holmes (Lamotrigine), 2008 Blotière (Lamotrigine) (Mixed indications), 2019
2
2.30
[
0.32
; 16.29]
1,743
3,681
not evaluable
Ano-rectal atresia and stenosis
Blotière (Lamotrigine) (Mixed indications), 2019
1
1.15
[
0.16
; 8.19]
545
2,997
not evaluable
Atrial septal defect
Blotière (Lamotrigine) (Mixed indications), 2019
1
1.50
[
0.77
; 2.90]
3,276
2,997
not evaluable
Atrioventricular septal defect
Blotière (Lamotrigine) (Mixed indications), 2019
1
0.59
[
0.04
; 9.46]
529
2,997
not evaluable
Bilateral renal agenesis including Potter syndrome
Blotière (Lamotrigine) (Mixed indications), 2019
1
4.15
[
0.26
; 66.90]
75
2,997
not evaluable
Bladder exstrophy and/or epispadia
Blotière (Lamotrigine) (Mixed indications), 2019
1
7.70
[
0.52
; 114.86]
83
2,997
not evaluable
Coarctation of aorta
Blotière (Lamotrigine) (Mixed indications), 2019
1
2.40
[
0.64
; 9.04]
782
2,997
not evaluable
Craniosynostosis
Blotière (Lamotrigine) (Mixed indications), 2019
1
0.41
[
0.03
; 6.53]
766
2,997
not evaluable
Diaphragmatic hernia
Blotière (Lamotrigine) (Mixed indications), 2019
1
1.66
[
0.23
; 11.79]
379
2,997
not evaluable
Digestive system anomalies
Thomas (Lamotrigine) (Controls unexposed, sick), 2021
1
2.28
[
0.09
; 56.74]
1
50
not evaluable
Ebstein's anomaly
Blotière (Lamotrigine) (Mixed indications), 2019
1
6.20
[
0.38
; 100.48]
50
2,997
not evaluable
Gastroschisis
Blotière (Lamotrigine) (Mixed indications), 2019
1
5.20
[
0.93
; 29.18]
245
2,997
not evaluable
Genital anomalies
Ban (Lamotrigine) (Mixed indications), 2015
1
0.92
[
0.13
; 6.56]
1,024
273
not evaluable
Hypoplastic left heart (HLH/HLHS)
Blotière (Lamotrigine) (Mixed indications), 2019
1
1.45
[
0.09
; 23.19]
216
2,997
not evaluable
Hypoplastic right heart (HRH/HRHS)
Blotière (Lamotrigine) (Mixed indications), 2019
1
4.71
[
0.29
; 76.05]
66
2,997
not evaluable
Microcephaly / Small head circumference for gestational age
Blotière (Lamotrigine) (Mixed indications), 2019
1
1.43
[
0.20
; 10.17]
439
2,997
not evaluable
Minor congenital malformations
0
-
-
-
-
-
Oesophageal atresia with or without tracheo-oesophageal fistula
Blotière (Lamotrigine) (Mixed indications), 2019
1
3.20
[
0.59
; 17.31]
394
2,997
not evaluable
Omphalocele
Blotière (Lamotrigine) (Mixed indications), 2019
1
2.40
[
0.21
; 27.68]
267
2,997
not evaluable
Polydactyly
Källén (Lamotrigine) (Indications NOS), 2013
1
1.33
[
0.35
; 5.05]
3,087
1,084
not evaluable
Pulmonary valve atresia
Blotière (Lamotrigine) (Mixed indications), 2019
1
2.05
[
0.13
; 32.97]
152
2,997
not evaluable
Tetralogy of Fallot
Blotière (Lamotrigine) (Mixed indications), 2019
1
0.54
[
0.03
; 8.57]
584
2,997
not evaluable
Urinary malformations
Thomas (Lamotrigine) (Controls unexposed, sick), 2021
1
1.14
[
0.13
; 9.64]
7
50
not evaluable
Ventricular septal defect
Blotière (Lamotrigine) (Mixed indications), 2019
1
1.30
[
0.69
; 2.46]
4,653
2,997
not evaluable
Growth parameters and prematurity
Preterm (< 37 weeks)
Cummings (Lamotrigine), 2011 Veiby (Lamotrigine) (Controls unexposed, sick) b, 2013 Artama (Lamotrigine) (Controls unexposed, sick), 2013 Hernández-Díaz (Lamotrigine) (Mixed indications), 2014 Kilic (Lamotrigine) (Controls unexposed, sick) (Mixed indications), 2014 Miškov (Lamotrigine) (Controls unexposed, sick), 2016 Cohen (Lamotrigine) (Mixed indications), 2019 Kernizan, 2019 Coste (Lamotrigine) (Controls unexposed NOS) (Mixed indications), 2020 Aydin (Lamotrigine), 2020 Van Marter (Lamotrigine) (Controls unexposed, sick), 2021 Bromley (Lamotrigine) (Epilepsy), 2023
12
1.11
[
0.97
; 1.26]
252,993
8,529
low
Small for gestational age (weight)
Artama (Lamotrigine) (Controls unexposed, sick), 2013 Veiby (Lamotrigine) (Controls unexposed, sick) b, 2013 Hernández-Díaz (Lamotrigine) (Mixed indications), 2014 Kilic (Lamotrigine) (Controls unexposed, sick) (Mixed indications), 2014 Cohen (Lamotrigine) (Mixed indications), 2019 Coste (Lamotrigine) (Controls unexposed NOS) (Mixed indications), 2020 Aydin (Lamotrigine), 2020 Dreier (Lamotrigine), 2021 Van Marter (Lamotrigine) (Controls unexposed, sick), 2021 Bromley (Lamotrigine) (Epilepsy), 2023
10
0.94
[
0.86
; 1.04]
209,968
13,126
low
Low birth weight (< 2500g)
Artama (Lamotrigine) (Controls unexposed, sick), 2013 Veiby (Lamotrigine) (Controls unexposed, sick) b, 2013 Kilic (Lamotrigine) (Controls unexposed, sick) (Mixed indications), 2014 Hernández-Díaz (Lamotrigine) (Mixed indications), 2014 Coste (Lamotrigine) (Controls unexposed NOS) (Mixed indications), 2020
5
1.16
[
1.02
; 1.32]
91,826
5,546
not evaluable
Extremely preterm (< 28 weeks)
Coste (Lamotrigine) (Controls unexposed NOS) (Mixed indications), 2020 Van Marter (Lamotrigine) (Controls unexposed, sick), 2021
2
0.51
[
0.14
; 1.87]
2,038
2,923
not evaluable
Very preterm (28 to 32 weeks)
Coste (Lamotrigine) (Controls unexposed NOS) (Mixed indications), 2020 Van Marter (Lamotrigine) (Controls unexposed, sick), 2021
2
0.53
[
0.19
; 1.45]
8,567
2,923
not evaluable
Large for gestational age (weight)
Artama (Lamotrigine) (Controls unexposed, sick), 2013 Aydin (Lamotrigine), 2020
2
1.47
[
0.05
; 41.93]
74
180
not evaluable
Macrosomia (> 4000g)
Coste (Lamotrigine) (Controls unexposed NOS) (Mixed indications), 2020
1
0.89
[
0.82
; 0.97]
577,180
2,813
not evaluable
Maternal consequences
Caesarean
Borthen (Lamotrigine) (Controls unexposed, sick), 2010 Artama (Lamotrigine) (Controls unexposed, sick), 2013
2
1.00
[
0.77
; 1.31]
744
406
not evaluable
Preeclampsia
Borthen (Lamotrigine) (Controls unexposed, sick), 2011 Cohen (Lamotrigine) (Mixed indications), 2019 Aydin (Lamotrigine), 2020
3
1.09
[
0.90
; 1.31]
53,780
2,719
not evaluable
Assisted deliveries (forceps, vacuum, ...)
Borthen (Lamotrigine) (Controls unexposed, sick), 2010
1
1.63
[
1.07
; 2.47]
185
233
not evaluable
Gestational diabetes
Rihtman (Lamotrigine), 2013 Aydin (Lamotrigine), 2020 Galbally, 2020
3
1.19
[
0.32
; 4.49]
19
66
not evaluable
Postpartum hemorrhage
Borthen (Lamotrigine) (Controls unexposed, sick), 2010
1
1.49
[
1.06
; 2.10]
324
233
not evaluable
Abruptio placentae (retroplacental hematoma)
Cohen (Lamotrigine) (Mixed indications), 2019
1
1.15
[
0.85
; 1.56]
20,319
2,682
not evaluable
Amniotic fluid problems (polyhydramnios and/or oligohydramnios)
Aydin (Lamotrigine), 2020
1
3.31
[
0.06
; 183.69]
-
7
not evaluable
Neonatal disorders
Low Apgar score (< 7) (at 5 min)
Borthen (Lamotrigine) (Controls unexposed, sick), 2010 Artama (Lamotrigine) (Controls unexposed, sick), 2013 Veiby (Lamotrigine) (Controls unexposed, sick) b, 2013 Christensen (Lamotrigine) (Controls unexposed, sick) (Mixed indications), 2015
4
1.22
[
0.76
; 1.94]
131
1,343
not evaluable
Neonatal medical care
Artama (Lamotrigine) (Controls unexposed, sick), 2013 Aydin (Lamotrigine), 2020 Bromley (Lamotrigine) (Epilepsy), 2023
3
2.08
[
1.10
; 3.93]
206
267
not evaluable
Neonatal disorders (as a whole)
Coste (Lamotrigine) (Controls unexposed NOS) (Mixed indications), 2020 Bromley (Lamotrigine) (Epilepsy), 2023
2
0.95
[
0.85
; 1.07]
222,157
2,919
not evaluable
Low Apgar score (< 7) (at 1 min)
Artama (Lamotrigine) (Controls unexposed, sick), 2013
1
1.69
[
0.35
; 8.14]
78
154
not evaluable
Withdrawal syndrome / Neonatal abstinence syndrome / Poor neonatal adaptation
Kernizan, 2019
1
0.65
[
0.08
; 5.30]
17
13
not evaluable
Fetal distress
0
-
-
-
-
-
Neonatal death (< 28 days of life)
Holmes (Lamotrigine) (Mixed indications), 2011
1
0.60
[
0.06
; 5.80]
4
948
not evaluable
Long term consequences
Behavioral disorders
Veiby (Lamotrigine) (Controls unexposed, sick) b, 2013 Dreier (Lamotrigine) (Epilepsy) (Controls unexposed, sick), 2023
2
1.00
[
0.35
; 2.85]
132
5,332
not evaluable
Child/Infant death (> 28 days of life)
Artama (Lamotrigine) (Controls unexposed, sick), 2013 Coste (Lamotrigine) (Controls unexposed NOS) (Mixed indications), 2020
2
1.22
[
0.65
; 2.30]
4,710
2,986
not evaluable
Emotional disorders
Cohen-Israel (Lamotrigine), 2018 Dreier (Lamotrigine) (Epilepsy) (Controls unexposed, sick), 2023
2
1.08
[
0.57
; 2.07]
557
5,371
not evaluable
Intrauterine deaths
Intrauterine deaths (as a whole or unspecified)
Holmes (Lamotrigine) (Mixed indications), 2011 Miškov (Lamotrigine) (Controls unexposed, sick), 2016 Vajda (Lamotrigine), 2018 Trivedi (Lamotrigine), 2018 Kernizan, 2019 Meador (Lamotrigine) (Controls unexposed, sick), 2020
6
3.03
[
1.12
; 8.22]
45
1,541
not evaluable
Elective/induced termination of pregnancy
Holmes (Lamotrigine) (Mixed indications), 2011 Miškov (Lamotrigine) (Controls unexposed, sick), 2016 Hosny, 2021
3
1.39
[
0.20
; 9.76]
5
988
not evaluable
Late intrauterine deaths (> 22 weeks)
Holmes (Lamotrigine) (Mixed indications), 2011 AlSheikh (Lamotrigine), 2020 Aydin (Lamotrigine), 2020
3
1.07
[
0.13
; 8.49]
2
975
not evaluable
Early intrauterine death (< 22 weeks)
Miškov (Lamotrigine) (Controls unexposed, sick), 2016
1
0.73
[
0.03
; 17.26]
3
37
not evaluable
Perinatal death
Artama (Lamotrigine) (Controls unexposed, sick), 2013
1
0.49
[
0.03
; 8.47]
10
173
not evaluable
Therapeutic terminations of pregnancy
Miškov (Lamotrigine) (Controls unexposed, sick), 2016
1
0.10
[
0.00
; 5.62]
-
37
not evaluable
Neuro-developmental disorders
Language disorders/delay
Rihtman (Lamotrigine), 2013 Baker (Lamotrigine) (Controls unexposed, sick), 2015 Videman (Lamotrigine), 2016 Kasradze (Lamotrigine), 2017 Cohen-Israel (Lamotrigine), 2018 Coste (Lamotrigine) (Controls unexposed NOS) (Mixed indications), 2020 Husebye (Lamotrigine) (Controls unexposed, sick), 2020 Bromley (Lamotrigine) (Epilepsy), 2023 Meador (Lamotrigine), 2023
9
1.12
[
0.79
; 1.58]
72,053
3,181
not evaluable
ASD (Autism spectrum disorder): Diagnosis/Risk
Bromley (Lamotrigine) (Controls unexposed, sick), 2013 Bjørk (Lamotrigine) (Controls unexposed, sick), 2018 Cohen-Israel (Lamotrigine), 2018 Coste (Lamotrigine) (Controls unexposed NOS) (Mixed indications), 2020 Wiggs (Lamotrigine), 2020 Bjørk (Lamotrigine) (Controls unexposed NOS) (Mixed indications), 2022 Bjørk (Lamotrigine) (Controls unexposed, sick) (Mixed indications), 2022
7
1.04
[
0.83
; 1.31]
43,174
18,902
not evaluable
Neuro-developmental disorders (as a whole)
Dean (Lamotrigine), 2007 Rihtman (Lamotrigine), 2013 Bromley (Lamotrigine) (Controls unexposed, sick), 2013 Charlton (Lamotrigine) (Controls unexposed, sick), 2017 Coste (Lamotrigine) (Controls unexposed NOS) (Mixed indications), 2020 Bjørk (Lamotrigine) (Controls unexposed, sick) (Mixed indications), 2022
6
1.08
[
0.66
; 1.76]
10,568
10,961
not evaluable
ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk
Veiby (Lamotrigine) (Controls unexposed, sick) b, 2013 Bromley (Lamotrigine) (Controls unexposed, sick), 2013 Rihtman (Lamotrigine), 2013 Richards (Lamotrigine) (Indications NOS), 2019 Wiggs (Lamotrigine), 2020 Dreier (Lamotrigine) (Epilepsy) (Controls unexposed, sick), 2023
6
1.21
[
0.81
; 1.81]
12,484
5,550
not evaluable
ASD (Autism spectrum disorder): Diagnosis
Bromley (Lamotrigine) (Controls unexposed, sick), 2013 Cohen-Israel (Lamotrigine), 2018 Coste (Lamotrigine) (Controls unexposed NOS) (Mixed indications), 2020 Wiggs (Lamotrigine), 2020 Bjørk (Lamotrigine) (Controls unexposed, sick) (Mixed indications), 2022
5
0.87
[
0.70
; 1.09]
4,615
10,876
not evaluable
Cognitive developmental disorders/delay (> 6 years old)
Baker (Lamotrigine) (Controls unexposed, sick), 2015 Gopinath (Lamotrigine), 2015 Cohen-Israel (Lamotrigine), 2018 Bjørk (Lamotrigine) (Controls unexposed, sick) (Mixed indications), 2022
4
0.59
[
0.42
; 0.83]
208
8,063
not evaluable
Psychomotor developmental disorders/delay
Bromley (Lamotrigine) (Controls unexposed, sick), 2013 Rihtman (Lamotrigine), 2013 Videman (Lamotrigine), 2016 Cohen-Israel (Lamotrigine), 2018 Bromley (Lamotrigine) (Epilepsy), 2023
5
2.21
[
1.14
; 4.32]
14
236
not evaluable
ADHD (Attention deficit hyperactivity disorder): Diagnosis
Bromley (Lamotrigine) (Controls unexposed, sick), 2013 Wiggs (Lamotrigine), 2020 Dreier (Lamotrigine) (Epilepsy) (Controls unexposed, sick), 2023
3
0.85
[
0.69
; 1.05]
623
5,318
not evaluable
Cognitive developmental disorders/delay (3-6 years old)
Cummings (Lamotrigine), 2011 Rihtman (Lamotrigine), 2013 Kasradze (Lamotrigine), 2017 Coste (Lamotrigine) (Controls unexposed NOS) (Mixed indications), 2020
4
2.53
[
1.15
; 5.56]
3,403
2,892
not evaluable
ADHD (Attention deficit hyperactivity disorder): Risk
Rihtman (Lamotrigine), 2013 Veiby (Lamotrigine) (Controls unexposed, sick) b, 2013 Richards (Lamotrigine) (Indications NOS), 2019
3
1.81
[
1.17
; 2.79]
11,861
232
not evaluable
Cognitive developmental disorders/delay (< 3 years old)
Bromley (Lamotrigine) (Controls unexposed, sick), 2010 Videman (Lamotrigine), 2016 Bromley (Lamotrigine) (Epilepsy), 2023
3
2.24
[
0.77
; 6.57]
11
115
not evaluable
Learning disorders
Cohen-Israel (Lamotrigine), 2018 Ren (Lamotrigine) (Mixed indications), 2023
2
0.92
[
0.74
; 1.13]
9
275
not evaluable
Severe cognitive developmental delay (Mental retardation) (3-6 years old)
Cummings (Lamotrigine), 2011 Coste (Lamotrigine) (Controls unexposed NOS) (Mixed indications), 2020
2
2.10
[
0.84
; 5.24]
3,401
2,848
not evaluable
Severe cognitive developmental delay (Mental retardation) (> 6 years old)
Bjørk (Lamotrigine) (Controls unexposed, sick) (Mixed indications), 2022
1
0.53
[
0.35
; 0.80]
166
7,950
not evaluable
ASD (Autism spectrum disorder): Risk
Bjørk (Lamotrigine) (Controls unexposed, sick), 2018
1
1.87
[
0.91
; 3.84]
40
76
not evaluable
Childhood autism (F84.0)
Christensen (Lamotrigine) (Indications NOS), 2013
1
1.70
[
0.53
; 5.48]
2,066
647
not evaluable
0.0
100.0
1.0