meta
|
Preg
- medecines during pregnancy KB
Search
Topiramate (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)
Morrow (Topiramate) (Controls unexposed, sick), 2006 Ornoy (Topiramate), 2008 Mawer (Topiramate) (Controls unexposed, sick), 2010 Margulis (Topiramate) (Mixed indication), 2012 Källén (Topiramate) (Controls unexposed, NOS) (Indications NOS), 2013 Veiby (Topiramate) (Controls unexposed, sick) (Mixed indications), 2014 Tomson (Topiramate), 2018 Vajda (Topiramate) (Controls unexposed, sick), 2019 Meador (Topiramate) (Controls unexposed, sick), 2020 Thomas (Topiramate) (Controls unexposed, sick), 2021 The NAAED (Controls unexposed, disease free) (Indications NOS), 2022 Cohen (Topiramate) (Mixed indications) (Controls unexposed, NOS), 2023
12
2.27
[
1.66
; 3.10]
231,350
1,410
low
Major congenital malformations
Morrow (Topiramate) (Controls unexposed, sick), 2006 Ornoy (Topiramate), 2008 Mawer (Topiramate) (Controls unexposed, sick), 2010 Margulis (Topiramate) (Mixed indication), 2012 Källén (Topiramate) (Controls unexposed, NOS) (Indications NOS), 2013 Veiby (Topiramate) (Controls unexposed, sick) (Mixed indications), 2014 Tomson (Topiramate), 2018 Vajda (Topiramate) (Controls unexposed, sick), 2019 Meador (Topiramate) (Controls unexposed, sick), 2020 Thomas (Topiramate) (Controls unexposed, sick), 2021 The NAAED (Controls unexposed, disease free) (Indications NOS), 2022 Cohen (Topiramate) (Mixed indications) (Controls unexposed, NOS), 2023
12
2.27
[
1.66
; 3.10]
231,350
1,410
low
Oro-facial clefts
Morrow (Topiramate) (Controls exposed to Lamotrigine, sick), 2006 Hernández-Díaz (Topiramate) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2012 Mines (Topiramate) (Other indications), 2014 Veiby (Topiramate) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 Hernandez-Diaz (Topiramate) (Mixed indications), 2018 Tomson (Topiramate), 2018 Blotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019 Lyons (Topiramate) (Indications NOS), 2023
8
3.15
[
2.12
; 4.69]
5,658
4,639
not evaluable
Congenital heart defects
Morrow (Topiramate) (Controls exposed to Lamotrigine, sick), 2006 Hernández-Díaz (Topiramate) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2012 Vajda (Topiramate) (Controls unexposed, sick), 2013 Tomson (Topiramate), 2018 Thomas (Topiramate) (Controls unexposed, sick), 2021
5
2.47
[
0.98
; 6.24]
36
592
not evaluable
Cleft lip with or without cleft palate
Margulis (Topiramate) (Mixed indication), 2012 Vajda (Topiramate) (Controls unexposed, sick), 2013 Mines (Topiramate) (Other indications), 2014 Blotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019
4
4.24
[
2.15
; 8.38]
4,700
2,319
not evaluable
Hypospadias
Morrow (Topiramate) (Controls exposed to Lamotrigine, sick), 2006 Hernández-Díaz (Topiramate) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2012 Tomson (Topiramate), 2018 Blotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019
4
4.03
[
1.56
; 10.45]
3,390
1,056
not evaluable
Limb defects
Morrow (Topiramate) (Controls exposed to Lamotrigine, sick), 2006 Vajda (Topiramate) (Controls unexposed, sick), 2013 Thomas (Topiramate) (Controls unexposed, sick), 2021
3
3.56
[
0.59
; 21.68]
5
81
not evaluable
Neural Tube Defects
Morrow (Topiramate) (Controls exposed to Lamotrigine, sick), 2006 Hernández-Díaz (Topiramate) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2012 Vajda (Topiramate) (Controls unexposed, sick), 2013 Tomson (Topiramate), 2018
4
3.21
[
0.62
; 16.76]
4
583
not evaluable
Spina bifida
Veiby (Topiramate) (Controls unexposed, sick) (Mixed indications), 2014 Blotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019
2
5.51
[
0.72
; 41.94]
619
565
not evaluable
Cleft palate
Mines (Topiramate) (Other indications), 2014 Blotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019
2
0.97
[
0.13
; 7.18]
1,184
2,262
not evaluable
Digestive system anomalies
Morrow (Topiramate) (Controls exposed to Lamotrigine, sick), 2006 Thomas (Topiramate) (Controls unexposed, sick), 2021
2
6.26
[
0.69
; 56.84]
4
37
not evaluable
Microcephaly / Small head circumference for gestational age
Veiby (Topiramate) (Controls unexposed, disease free) (Mixed indications), 2014 Blotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019
2
7.34
[
3.39
; 15.86]
18,960
565
not evaluable
Urinary malformations
Tomson (Topiramate), 2018 Thomas (Topiramate) (Controls unexposed, sick), 2021
2
1.68
[
0.22
; 13.11]
14
161
not evaluable
Ano-rectal atresia and stenosis
Blotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019
1
3.33
[
0.21
; 53.44]
544
517
not evaluable
Atrial septal defect
Blotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019
1
2.30
[
0.44
; 12.02]
3,270
517
not evaluable
Atrioventricular septal defect
Blotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019
1
3.43
[
0.21
; 54.96]
529
517
not evaluable
Bilateral renal agenesis including Potter syndrome
Blotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019
1
24.05
[
1.49
; 388.57]
75
517
not evaluable
Bladder exstrophy and/or epispadia
Blotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019
1
22.01
[
1.36
; 355.32]
82
517
not evaluable
Club foot / Talipes equinovarus
Blotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019
1
2.20
[
0.20
; 24.50]
1,678
517
not evaluable
Coarctation of aorta
Blotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019
1
2.33
[
0.15
; 37.31]
779
517
not evaluable
Craniosynostosis
Blotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019
1
2.37
[
0.15
; 37.95]
766
517
not evaluable
Diaphragmatic hernia
Blotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019
1
9.80
[
0.59
; 162.81]
379
517
not evaluable
Ebstein's anomaly
Blotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019
1
35.96
[
2.22
; 583.57]
50
517
not evaluable
Gastroschisis
Blotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019
1
7.46
[
0.46
; 119.71]
243
517
not evaluable
Hypoplastic left heart (HLH/HLHS)
Blotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019
1
8.39
[
0.52
; 134.69]
216
517
not evaluable
Hypoplastic right heart (HRH/HRHS)
Blotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019
1
27.30
[
1.69
; 441.71]
66
517
not evaluable
Nervous system anomalies
Thomas (Topiramate) (Controls unexposed, sick), 2021
1
39.94
[
0.75
; 2134.65]
-
9
not evaluable
Oesophageal atresia with or without tracheo-oesophageal fistula
Blotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019
1
9.40
[
0.58
; 153.31]
393
517
not evaluable
Omphalocele
Blotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019
1
6.81
[
0.42
; 109.35]
266
517
not evaluable
Pulmonary valve atresia
Blotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019
1
11.91
[
0.74
; 191.48]
152
517
not evaluable
Tetralogy of Fallot
Blotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019
1
3.11
[
0.19
; 49.78]
584
517
not evaluable
Ventricular septal defect
Blotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019
1
1.60
[
0.30
; 8.62]
4,645
517
not evaluable
Polydactyly
Tomson (Topiramate), 2018
1
16.59
[
0.33
; 839.05]
-
152
not evaluable
Growth parameters and prematurity
Preterm (< 37 weeks)
Kilic (Topiramate) (Controls unexposed, sick) (Mixed indications), 2014 Hernández-Díaz (Topiramate) (Mixed indications) (Controls unexposed, disease free), 2014 Arkilo (Topiramate), 2015 Bank (Topiramate) (Mixed indications) , 2017 Cohen (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019 Coste (Topiramate) (Controls unexposed, NOS) (Mixed indications), 2020
6
1.34
[
0.87
; 2.05]
252,656
3,167
not evaluable
Small for gestational age (weight)
Kilic (Topiramate) (Controls unexposed, sick) (Mixed indications), 2014 Veiby (Topiramate) (Controls unexposed, sick) (Mixed indications), 2014 Bank (Topiramate) (Mixed indications) , 2017 Hernández-Díaz (Topiramate), 2017 Cohen (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019 Coste (Topiramate) (Controls unexposed, NOS) (Mixed indications), 2020 Dreier (Topiramate), 2021
7
1.64
[
1.13
; 2.38]
210,181
3,477
not evaluable
Low birth weight (< 2500g)
Hernández-Díaz (Topiramate) (Mixed indications) (Controls unexposed, disease free), 2014 Kilic (Topiramate) (Controls unexposed, sick) (Mixed indications), 2014 Coste (Topiramate) (Controls unexposed, NOS) (Mixed indications), 2020
3
1.51
[
1.06
; 2.15]
91,787
883
not evaluable
Macrosomia (> 4000g)
Coste (Topiramate) (Controls unexposed, NOS) (Mixed indications), 2020
1
0.92
[
0.76
; 1.11]
577,249
477
not evaluable
Very preterm (28 to 32 weeks)
Coste (Topiramate) (Controls unexposed, NOS) (Mixed indications), 2020
1
2.53
[
1.13
; 5.65]
8,590
477
not evaluable
Extremely preterm (< 28 weeks)
Coste (Topiramate) (Controls unexposed, NOS) (Mixed indications), 2020
1
1.76
[
0.25
; 12.52]
2,042
477
not evaluable
Maternal consequences
Abruptio placentae (retroplacental hematoma)
Cohen (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019
1
1.27
[
0.96
; 1.68]
20,323
2,280
not evaluable
Preeclampsia
Cohen (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019
1
1.06
[
0.89
; 1.26]
53,765
2,280
not evaluable
Neonatal disorders
Neonatal disorders (as a whole)
Coste (Topiramate) (Controls unexposed, NOS) (Mixed indications), 2020
1
1.23
[
0.96
; 1.58]
222,275
477
not evaluable
Low Apgar score (< 7) (at 1 min)
Bank (Topiramate) (Mixed indications) , 2017
1
4.47
[
0.14
; 140.56]
2
2
not evaluable
Low Apgar score (< 7) (at 5 min)
Bank (Topiramate) (Mixed indications) , 2017
1
23.67
[
0.34
; 1653.93]
-
2
not evaluable
Neonatal medical care
Bank (Topiramate) (Mixed indications) , 2017
1
5.00
[
0.27
; 91.52]
7
2
not evaluable
Long term consequences
Emotional disorders
Bromley (Topiramate), 2016 Dreier (Topiramate) (Epilepsy) (Controls unexposed, sick), 2023
2
0.92
[
0.43
; 1.97]
466
317
not evaluable
Behavioral disorders
Bromley (Topiramate), 2016
1
0.84
[
0.36
; 1.94]
-
27
not evaluable
Child/Infant death (> 28 days of life)
Coste (Topiramate) (Controls unexposed, NOS) (Mixed indications), 2020
1
0.76
[
0.11
; 5.43]
4,696
477
not evaluable
Intrauterine deaths
Intrauterine deaths (as a whole or unspecified)
Arkilo (Topiramate), 2015 Vajda (Topiramate) (Controls unexposed, sick), 2018 Trivedi (Topiramate) (Controls unexposed, sick), 2018 Meador (Topiramate) (Controls unexposed, sick), 2020
4
9.39
[
2.18
; 40.53]
14
70
not evaluable
Late intrauterine deaths (> 22 weeks)
Arkilo (Topiramate), 2015 AlSheikh (Topiramate) (Controls unexposed, sick), 2020
2
15.37
[
0.63
; 376.77]
-
3
not evaluable
Early intrauterine death (< 22 weeks)
Babic (Topiramate), 2014 Arkilo (Topiramate), 2015
2
8.47
[
0.57
; 125.19]
3
4
not evaluable
Neuro-developmental disorders
ASD (Autism spectrum disorder): Diagnosis/Risk
Wood (Topiramate), 2015 Bjørk (Topiramate) (Controls exposed to Lamotrigine, sick), 2018 Bjørk (Topiramate) (Controls unexposed, sick), 2018 Coste (Topiramate) (Controls unexposed, NOS) (Mixed indications), 2020 Bjørk (Topiramate) (Controls unexposed NOS) (Mixed indications), 2022 Bjørk (Topiramate) (Controls unexposed, sick) (Mixed indications), 2022
6
2.20
[
1.50
; 3.23]
43,051
1,432
not evaluable
Language disorders/delay
Rihtman (Topiramate) (Mixed indications), 2012 Bromley (Topiramate), 2016 Husebye (Topiramate) (Controls unexposed, sick), 2020 Coste (Topiramate) (Controls unexposed, NOS) (Mixed indications), 2020 Meador (Topiramate) (Controls unexposed, disease free), 2021
5
1.52
[
1.10
; 2.10]
72,088
522
not evaluable
ASD (Autism spectrum disorder): Diagnosis
Wood (Topiramate), 2015 Coste (Topiramate) (Controls unexposed, NOS) (Mixed indications), 2020 Bjørk (Topiramate) (Controls unexposed, sick) (Mixed indications), 2022
3
1.96
[
1.12
; 3.42]
4,560
949
not evaluable
ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk
Rihtman (Topiramate) (Mixed indications), 2012 Bromley (Topiramate), 2016 Richards (Topiramate) (Controls unexposed, NOS) (Indications NOS), 2019 Dreier (Topiramate) (Epilepsy) (Controls unexposed, sick), 2023
4
1.78
[
0.89
; 3.56]
12,385
353
not evaluable
Neuro-developmental disorders (as a whole)
Arkilo (Topiramate), 2015 Coste (Topiramate) (Controls unexposed, NOS) (Mixed indications), 2020 Bjørk (Topiramate) (Controls unexposed, sick) (Mixed indications), 2022
3
1.49
[
0.94
; 2.35]
10,474
950
not evaluable
ADHD (Attention deficit hyperactivity disorder): Risk
Rihtman (Topiramate) (Mixed indications), 2012 Bromley (Topiramate), 2016 Richards (Topiramate) (Controls unexposed, NOS) (Indications NOS), 2019
3
1.41
[
0.46
; 4.32]
11,841
63
not evaluable
ASD (Autism spectrum disorder): Risk
Wood (Topiramate), 2015 Bjørk (Topiramate) (Controls unexposed, sick), 2018
2
2.65
[
0.36
; 19.38]
28
7
not evaluable
Cognitive developmental disorders/delay (3-6 years old)
Rihtman (Topiramate) (Mixed indications), 2012 Coste (Topiramate) (Controls unexposed, NOS) (Mixed indications), 2020
2
3.91
[
0.71
; 21.54]
3,400
486
not evaluable
Cognitive developmental disorders/delay (> 6 years old)
Bromley (Topiramate), 2016 Bjørk (Topiramate) (Controls unexposed, sick) (Mixed indications), 2022
2
2.03
[
0.97
; 4.24]
151
498
not evaluable
Severe cognitive developmental delay (Mental retardation) (3-6 years old)
Coste (Topiramate) (Controls unexposed, NOS) (Mixed indications), 2020
1
1.70
[
0.41
; 7.01]
3,400
477
not evaluable
Severe cognitive developmental delay (Mental retardation) (> 6 years old)
Bjørk (Topiramate) (Controls unexposed, sick) (Mixed indications), 2022
1
2.00
[
0.88
; 4.54]
145
471
not evaluable
ADHD (Attention deficit hyperactivity disorder): Diagnosis
Dreier (Topiramate) (Epilepsy) (Controls unexposed, sick), 2023
1
2.38
[
1.40
; 4.05]
544
290
not evaluable
Psychomotor developmental disorders/delay
Rihtman (Topiramate) (Mixed indications), 2012
1
4.10
[
0.91
; 18.48]
-
9
not evaluable
0.0
100.0
1.0