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Levetiracetam (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 (Levetiracetam) (Controls unexposed, sick), 2006 Källén (Levetiracetam) (Controls unexposed, NOS) (Indications NOS), 2013 Veiby (Levetiracetam) (Controls unexposed, sick), 2014 Tomson (Levetiracetam), 2018 Huber-Mollema (Levetiracetam), 2019 Vajda (Levetiracetam) (Controls unexposed, sick), 2019 Meador (Levetiracetam) (Controls unexposed, sick), 2020 Aydin (Levetiracetam) (Controls unexposed, sick), 2020 Thomas (Levetiracetam) (Controls unexposed, sick), 2021 Hosny (Levetiracetam) (Controls unexposed, sick), 2021 The NAAED (Controls unexposed, disease free) (Indications NOS), 2022 Mari (Levetiracetam), 2022 Cohen (Levetiracetam) (Epilepsy) (Controls unexposed, NOS), 2023
13
1.04
[
0.81
; 1.33]
197,745
3,477
low
Major congenital malformations
Morrow (Levetiracetam) (Controls unexposed, sick), 2006 Källén (Levetiracetam) (Controls unexposed, NOS) (Indications NOS), 2013 Veiby (Levetiracetam) (Controls unexposed, sick), 2014 Tomson (Levetiracetam), 2018 Vajda (Levetiracetam) (Controls unexposed, sick), 2019 Huber-Mollema (Levetiracetam), 2019 Meador (Levetiracetam) (Controls unexposed, sick), 2020 Thomas (Levetiracetam) (Controls unexposed, sick), 2021 Hosny (Levetiracetam) (Controls unexposed, sick), 2021 The NAAED (Controls unexposed, disease free) (Indications NOS), 2022 Mari (Levetiracetam), 2022 Cohen (Levetiracetam) (Epilepsy) (Controls unexposed, NOS), 2023
12
1.03
[
0.81
; 1.32]
197,745
3,467
low
Congenital heart defects
Morrow (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2006 Hernández-Díaz (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2012 Tomson (Levetiracetam), 2018 Thomas (Levetiracetam) (Controls unexposed, sick), 2021
4
1.33
[
0.64
; 2.78]
40
1,177
not evaluable
Hypospadias
Morrow (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2006 Hernández-Díaz (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2012 Tomson (Levetiracetam), 2018 Blotière (Levetiracetam) (Controls unexposed NOS) (Mixed indications), 2019
4
1.01
[
0.26
; 3.95]
3,384
1,650
not evaluable
Oro-facial clefts
Morrow (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2006 Hernández-Díaz (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2012 Tomson (Levetiracetam), 2018 Blotière (Levetiracetam) (Controls unexposed NOS) (Mixed indications), 2019
4
1.24
[
0.37
; 4.19]
2,828
1,650
not evaluable
Spina bifida
Vajda (Levetiracetam) (Controls unexposed, sick), 2013 Veiby (Levetiracetam) (Controls unexposed, sick), 2014 Blotière (Levetiracetam) (Controls unexposed NOS) (Mixed indications), 2019
3
3.19
[
0.53
; 19.33]
619
756
not evaluable
Cleft lip with or without cleft palate
Vajda (Levetiracetam) (Controls unexposed, sick), 2013 Blotière (Levetiracetam) (Controls unexposed NOS) (Mixed indications), 2019
2
2.09
[
0.28
; 15.72]
1,638
642
not evaluable
Digestive system anomalies
Morrow (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2006 Thomas (Levetiracetam) (Controls unexposed, sick), 2021
2
2.24
[
0.25
; 20.02]
4
128
not evaluable
Limb defects
Morrow (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2006 Thomas (Levetiracetam) (Controls unexposed, sick), 2021
2
3.89
[
0.74
; 20.42]
6
128
not evaluable
Minor congenital malformations
Mari (Levetiracetam), 2022
1
2.03
[
0.08
; 54.83]
1
17
not evaluable
Neural Tube Defects
Morrow (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2006 Hernández-Díaz (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2012 Tomson (Levetiracetam), 2018
3
2.59
[
0.50
; 13.52]
5
1,071
not evaluable
Urinary malformations
Tomson (Levetiracetam), 2018 Thomas (Levetiracetam) (Controls unexposed, sick), 2021
2
0.53
[
0.12
; 2.33]
16
705
not evaluable
Ano-rectal atresia and stenosis
Blotière (Levetiracetam) (Controls unexposed NOS) (Mixed indications), 2019
1
2.98
[
0.19
; 47.71]
544
579
not evaluable
Atrial septal defect
Blotière (Levetiracetam) (Controls unexposed NOS) (Mixed indications), 2019
1
0.99
[
0.14
; 7.05]
3,269
579
not evaluable
Atrioventricular septal defect
Blotière (Levetiracetam) (Controls unexposed NOS) (Mixed indications), 2019
1
3.06
[
0.19
; 49.06]
529
579
not evaluable
Bilateral renal agenesis including Potter syndrome
Blotière (Levetiracetam) (Controls unexposed NOS) (Mixed indications), 2019
1
21.47
[
1.33
; 346.88]
75
579
not evaluable
Bladder exstrophy and/or epispadia
Blotière (Levetiracetam) (Controls unexposed NOS) (Mixed indications), 2019
1
19.65
[
1.22
; 317.20]
82
579
not evaluable
Cleft palate
Blotière (Levetiracetam) (Controls unexposed NOS) (Mixed indications), 2019
1
1.37
[
0.09
; 22.02]
1,178
579
not evaluable
Club foot / Talipes equinovarus
Blotière (Levetiracetam) (Controls unexposed NOS) (Mixed indications), 2019
1
1.93
[
0.27
; 13.76]
1,678
579
not evaluable
Coarctation of aorta
Blotière (Levetiracetam) (Controls unexposed NOS) (Mixed indications), 2019
1
4.20
[
0.27
; 64.25]
780
579
not evaluable
Craniosynostosis
Blotière (Levetiracetam) (Controls unexposed NOS) (Mixed indications), 2019
1
4.20
[
0.27
; 64.79]
767
579
not evaluable
Diaphragmatic hernia
Blotière (Levetiracetam) (Controls unexposed NOS) (Mixed indications), 2019
1
4.28
[
0.27
; 68.68]
378
579
not evaluable
Ebstein's anomaly
Blotière (Levetiracetam) (Controls unexposed NOS) (Mixed indications), 2019
1
32.10
[
1.98
; 520.95]
50
579
not evaluable
Gastroschisis
Blotière (Levetiracetam) (Controls unexposed NOS) (Mixed indications), 2019
1
6.66
[
0.41
; 106.87]
243
579
not evaluable
Hypoplastic left heart (HLH/HLHS)
Blotière (Levetiracetam) (Controls unexposed NOS) (Mixed indications), 2019
1
15.10
[
1.03
; 220.38]
217
579
not evaluable
Hypoplastic right heart (HRH/HRHS)
Blotière (Levetiracetam) (Controls unexposed NOS) (Mixed indications), 2019
1
24.38
[
1.51
; 394.31]
66
579
not evaluable
Microcephaly / Small head circumference for gestational age
Blotière (Levetiracetam) (Controls unexposed NOS) (Mixed indications), 2019
1
3.70
[
0.23
; 59.26]
438
579
not evaluable
Nervous system anomalies
Thomas (Levetiracetam) (Controls unexposed, sick), 2021
1
3.22
[
0.06
; 163.18]
-
106
not evaluable
Oesophageal atresia with or without tracheo-oesophageal fistula
Blotière (Levetiracetam) (Controls unexposed NOS) (Mixed indications), 2019
1
4.13
[
0.26
; 66.22]
392
579
not evaluable
Omphalocele
Blotière (Levetiracetam) (Controls unexposed NOS) (Mixed indications), 2019
1
6.08
[
0.38
; 97.62]
266
579
not evaluable
Pulmonary valve atresia
Blotière (Levetiracetam) (Controls unexposed NOS) (Mixed indications), 2019
1
10.63
[
0.66
; 170.93]
152
579
not evaluable
Tetralogy of Fallot
Blotière (Levetiracetam) (Controls unexposed NOS) (Mixed indications), 2019
1
2.77
[
0.17
; 44.44]
584
579
not evaluable
Ventricular septal defect
Blotière (Levetiracetam) (Controls unexposed NOS) (Mixed indications), 2019
1
0.70
[
0.10
; 4.96]
4,644
579
not evaluable
Polydactyly
Tomson (Levetiracetam), 2018
1
4.20
[
0.08
; 211.88]
-
599
not evaluable
Growth parameters and prematurity
Preterm (< 37 weeks)
Artama (Levetiracetam) (Controls unexposed, sick), 2013 Kilic (Levetiracetam) (Controls unexposed, sick) (Mixed indications), 2014 Arkilo (Levetiracetam), 2015 Bank (Levetiracetam) (Mixed indications), 2017 Coste (Levetiracetam) (Controls unexposed, NOS), 2020 Aydin (Levetiracetam) (Controls unexposed, sick), 2020 Van Marter (Levetiracetam) (Controls unexposed, sick), 2021 Bromley (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2023
8
1.49
[
1.15
; 1.94]
91,815
855
not evaluable
Small for gestational age (weight)
Artama (Levetiracetam) (Controls unexposed, sick), 2013 Kilic (Levetiracetam) (Controls unexposed, sick) (Mixed indications), 2014 Bank (Levetiracetam) (Mixed indications), 2017 Aydin (Levetiracetam) (Controls unexposed, sick), 2020 Coste (Levetiracetam) (Controls unexposed, NOS), 2020 Dreier (Levetiracetam), 2021 Van Marter (Levetiracetam) (Controls unexposed, sick), 2021 Bromley (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2023
8
1.22
[
0.96
; 1.54]
168,129
1,855
not evaluable
Low birth weight (< 2500g)
Artama (Levetiracetam) (Controls unexposed, sick), 2013 Kilic (Levetiracetam) (Controls unexposed, sick) (Mixed indications), 2014 Coste (Levetiracetam) (Controls unexposed, NOS), 2020
3
1.93
[
1.49
; 2.50]
91,833
660
not evaluable
Large for gestational age (weight)
Artama (Levetiracetam) (Controls unexposed, sick), 2013 Aydin (Levetiracetam) (Controls unexposed, sick), 2020
2
1.28
[
0.13
; 12.96]
71
23
not evaluable
Very preterm (28 to 32 weeks)
Coste (Levetiracetam) (Controls unexposed, NOS), 2020 Van Marter (Levetiracetam) (Controls unexposed, sick), 2021
2
1.10
[
0.20
; 5.96]
8,593
718
not evaluable
Extremely preterm (< 28 weeks)
Coste (Levetiracetam) (Controls unexposed, NOS), 2020 Van Marter (Levetiracetam) (Controls unexposed, sick), 2021
2
1.01
[
0.19
; 5.41]
2,043
718
not evaluable
Macrosomia (> 4000g)
Coste (Levetiracetam) (Controls unexposed, NOS), 2020
1
0.67
[
0.56
; 0.80]
577,255
621
not evaluable
Maternal consequences
Caesarean
Artama (Levetiracetam) (Controls unexposed, sick), 2013 Koc (Levetiracetam), 2018
2
1.50
[
0.67
; 3.41]
365
41
not evaluable
Amniotic fluid problems (polyhydramnios and/or oligohydramnios)
Aydin (Levetiracetam) (Controls unexposed, sick), 2020 Mari (Levetiracetam), 2022
2
1.20
[
0.07
; 20.23]
-
27
not evaluable
Gestational diabetes
Aydin (Levetiracetam) (Controls unexposed, sick), 2020 Mari (Levetiracetam), 2022
2
0.37
[
0.04
; 3.82]
2
27
not evaluable
Preeclampsia
Aydin (Levetiracetam) (Controls unexposed, sick), 2020
1
2.26
[
0.04
; 122.79]
-
10
not evaluable
Maternal consequences (as a whole)
Alsfouk (Levetiracetam), 2022
1
1.33
[
0.28
; 6.39]
9
24
not evaluable
Maternal death
Mari (Levetiracetam), 2022
1
0.64
[
0.01
; 34.59]
-
17
not evaluable
Maternal liver disorder / failure during pregnancy
Mari (Levetiracetam), 2022
1
0.64
[
0.01
; 34.59]
-
17
not evaluable
Neonatal disorders
Neonatal medical care
Artama (Levetiracetam) (Controls unexposed, sick), 2013 Bank (Levetiracetam) (Mixed indications), 2017 Aydin (Levetiracetam) (Controls unexposed, sick), 2020 Bromley (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2023
4
1.40
[
0.62
; 3.15]
177
99
not evaluable
Low Apgar score (< 7) (at 1 min)
Artama (Levetiracetam) (Controls unexposed, sick), 2013 Bank (Levetiracetam) (Mixed indications), 2017
2
2.01
[
0.39
; 10.26]
73
19
not evaluable
Low Apgar score (< 7) (at 5 min)
Artama (Levetiracetam) (Controls unexposed, sick), 2013 Bank (Levetiracetam) (Mixed indications), 2017
2
7.00
[
0.63
; 78.08]
3
19
not evaluable
Neonatal disorders (as a whole)
Coste (Levetiracetam) (Controls unexposed, NOS), 2020 Bromley (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2023
2
1.06
[
0.85
; 1.33]
222,315
691
not evaluable
Long term consequences
Child/Infant death (> 28 days of life)
Artama (Levetiracetam) (Controls unexposed, sick), 2013 Coste (Levetiracetam) (Controls unexposed, NOS), 2020
2
2.96
[
0.53
; 16.41]
4,703
634
not evaluable
Emotional disorders
Bromley (Levetiracetam), 2016 Huber-Mollema (Levetiracetam), 2019 Dreier (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2023
3
1.29
[
0.67
; 2.49]
503
1,131
not evaluable
Behavioral disorders
Bromley (Levetiracetam), 2016 Huber-Mollema (Levetiracetam), 2019
2
0.79
[
0.43
; 1.45]
19
70
not evaluable
Intrauterine deaths
Intrauterine deaths (as a whole or unspecified)
Tomson (Levetiracetam), 2015 Arkilo (Levetiracetam), 2015 Trivedi (Levetiracetam) (Controls unexposed, sick), 2018 Vajda (Levetiracetam) (Controls unexposed, sick), 2018 Koc (Levetiracetam), 2018 Meador (Levetiracetam) (Controls unexposed, sick), 2020
6
1.15
[
0.78
; 1.69]
202
656
not evaluable
Late intrauterine deaths (> 22 weeks)
Tomson (Levetiracetam), 2015 Arkilo (Levetiracetam), 2015 AlSheikh (Levetiracetam) (Controls unexposed, sick), 2020 Aydin (Levetiracetam) (Controls unexposed, sick), 2020 Mari (Levetiracetam), 2022
5
1.72
[
0.43
; 6.99]
9
371
not evaluable
Perinatal death
Artama (Levetiracetam) (Controls unexposed, sick), 2013 Tomson (Levetiracetam), 2015
2
2.47
[
0.31
; 19.60]
13
309
not evaluable
Early intrauterine death (< 22 weeks)
Babic (Levetiracetam), 2014 Arkilo (Levetiracetam), 2015 Tomson (Levetiracetam), 2015
3
1.10
[
0.72
; 1.68]
173
339
not evaluable
Elective/induced termination of pregnancy
Hosny (Levetiracetam) (Controls unexposed, sick), 2021 Mari (Levetiracetam), 2022
2
0.44
[
0.03
; 7.32]
-
84
not evaluable
Neuro-developmental disorders
Language disorders/delay
Shallcross (Levetiracetam), 2011 Videman (Levetiracetam) (Controls unexposed, disease free), 2016 Bromley (Levetiracetam), 2016 Coste (Levetiracetam) (Controls unexposed, NOS), 2020 Husebye (Levetiracetam) (Controls unexposed, sick), 2020 Bromley (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2023 Meador (Controls unexposed, disease free), 2023
7
0.89
[
0.68
; 1.16]
72,083
851
not evaluable
ASD (Autism spectrum disorder): Diagnosis/Risk
Bjørk (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2018 Bjørk (Levetiracetam) (Controls unexposed, sick), 2018 Huber-Mollema (Levetiracetam), 2019 Coste (Levetiracetam) (Controls unexposed, NOS), 2020 Bjørk (Levetiracetam) (Controls unexposed NOS), 2022 Bjørk (Levetiracetam) (Controls unexposed, sick), 2022
6
1.74
[
1.14
; 2.66]
43,055
2,696
not evaluable
ASD (Autism spectrum disorder): Diagnosis
Huber-Mollema (Levetiracetam), 2019 Coste (Levetiracetam) (Controls unexposed, NOS), 2020 Bjørk (Levetiracetam) (Controls unexposed, sick), 2022
3
1.40
[
0.75
; 2.61]
4,563
1,655
not evaluable
Neuro-developmental disorders (as a whole)
Arkilo (Levetiracetam), 2015 Coste (Levetiracetam) (Controls unexposed, NOS), 2020 Bjørk (Levetiracetam) (Controls unexposed, sick), 2022
3
1.08
[
0.65
; 1.80]
10,470
1,636
not evaluable
Cognitive developmental disorders/delay (< 3 years old)
Shallcross (Levetiracetam), 2011 Videman (Levetiracetam) (Controls unexposed, disease free), 2016 Bromley (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2023
3
1.56
[
0.51
; 4.80]
23
109
not evaluable
Psychomotor developmental disorders/delay
Shallcross (Levetiracetam), 2011 Videman (Levetiracetam) (Controls unexposed, disease free), 2016 Bromley (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2023
3
1.08
[
0.53
; 2.22]
9
109
not evaluable
ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk
Bromley (Levetiracetam), 2016 Huber-Mollema (Levetiracetam), 2019 Dreier (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2023
3
1.18
[
0.58
; 2.39]
547
1,133
not evaluable
ASD (Autism spectrum disorder): Risk
Bjørk (Levetiracetam) (Controls unexposed, sick), 2018 Huber-Mollema (Levetiracetam), 2019
2
2.39
[
0.45
; 12.72]
36
40
not evaluable
ADHD (Attention deficit hyperactivity disorder): Diagnosis
Huber-Mollema (Levetiracetam), 2019 Dreier (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2023
2
1.17
[
0.24
; 5.62]
547
1,091
not evaluable
Cognitive developmental disorders/delay (3-6 years old)
Coste (Levetiracetam) (Controls unexposed, NOS), 2020
1
0.70
[
0.10
; 4.90]
3,399
621
not evaluable
Severe cognitive developmental delay (Mental retardation) (3-6 years old)
Coste (Levetiracetam) (Controls unexposed, NOS), 2020
1
0.70
[
0.10
; 4.90]
3,399
621
not evaluable
ADHD (Attention deficit hyperactivity disorder): Risk
Bromley (Levetiracetam), 2016 Huber-Mollema (Levetiracetam), 2019
2
0.91
[
0.47
; 1.79]
7
70
not evaluable
Cognitive developmental disorders/delay (> 6 years old)
Bromley (Levetiracetam), 2016
1
2.34
[
0.53
; 10.42]
8
42
not evaluable
0.0
100.0
1.0