| id | Study | Lib. in paper | Exposition period | Study type |
Control type |
Tags | OR 95%CI | x1/n1 x0/n0 | no cases | no exposed | ROB | Ref. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| S19389 R82354 |
Honybun (Controls exposed to LTG) (Carbamazepine) (Epilepsy), 2026 | Verbal Comprehension Index - Wechsler Intelligence Scale - Children aged 3–18 years (mean age about 10 years) | during pregnancy (anytime or not specified) | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No extrapolated (cont. endpoint) |
2.26 [0.75;6.81] excluded (control group) |
-/20 -/23 | - | 20 |
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| S19304 R81721 |
Honybun (Controls unexposed, sick) (Carbamazepine) (Epilepsy), 2026 | Verbal Comprehension Index - Wechsler Intelligence Scale - Children aged 3–18 years (mean age about 10 years) | during pregnancy (anytime or not specified) | prospective cohort | unexposed, sick | Adjustment: No extrapolated (cont. endpoint) | 6.53 [1.93;22.15] | -/20 -/19 | - | 20 |
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| S19377 R82250 |
Straub (Controls exposed to LTG) (Carbamazepine) (Epilepsy), 2026 | Speech or language disorder - ICD-10 codes: F80.xx (except F80.4), H93.25 - Mean follow up (full cohort): 3.4 years | during pregnancy (anytime or not specified) | retrospective cohort (claims database) | exposed to other treatment, sick excluded | Adjustment: No |
1.14 [0.88;1.48] C excluded (control group) |
94/1,548 175/3,273 | 269 | 1,548 |
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| S19368 R82106 |
Straub (Controls unexposed, sick) (Carbamazepine) (Epilepsy), 2026 | Speech or language disorder - ICD-10 codes: F80.xx (except F80.4), H93.25 - Mean follow up (full cohort): 3.4 years | during pregnancy (anytime or not specified) | retrospective cohort (claims database) | unexposed, sick | Adjustment: Yes | 1.04 [0.82;1.33] | 94/1,548 456/8,887 | 550 | 1,548 |
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| S19338 R82011 |
Moore (Controls exposed to LTG) (Carbamazepine) (Indication NOS), 2025 | Speech, language and communication disorders - Assessment offered to all children - At the 27–30 months | during pregnancy (anytime or not specified) | population based cohort retrospective | exposed to other treatment, sick excluded | Adjustment: No |
1.11 [0.81;1.51] C excluded (control group) |
69/345 172/934 | 241 | 345 |
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| S19331 R82029 |
Moore (Controls unexposed, general pop) (Carbamazepine) (Indication NOS), 2025 | Speech, language and communication disorders - Assessment offered to all children - At the 27–30 months | during pregnancy (anytime or not specified) | population based cohort retrospective | unexposed (general population or NOS) | Adjustment: No Matched | 1.84 [1.38;2.44] C | 69/345 413/3,449 | 482 | 345 |
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| S16561 R69588 |
Stjerna (Carbamazepine) (Epilepsy), 2024 | Verbal intelligence quotient (VIQ continuous) - The Wechsler Intelligence Scale for Children (WISC-III) - At 6-7 years old | throughout pregnancy | retrospective cohort | exposed to other treatment, sick | Adjustment: Yes extrapolated (cont. endpoint) | 1.27 [0.62;2.62] | -/36 -/74 | - | 36 |
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| S15367 R63242 |
Bromley (Carbamazepine) (Epilepsy) (Controls exposed to LTG), 2023 | Language mean score ≤ 86 (below average performance of the cohort mean) - Bayley Scales of Infant and Toddler Development - At 24 months of age | during pregnancy (anytime or not specified) | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No |
1.82 [0.31;10.68] C excluded (control group) |
2/21 4/73 | 6 | 21 |
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| S15368 R63255 |
Bromley (Carbamazepine) (Epilepsy) (Controls unexposed, sick), 2023 | Language mean score ≤ 86 (below average performance of the cohort mean) - Bayley Scales of Infant and Toddler Development - At 24 months of age | during pregnancy (anytime or not specified) | prospective cohort | unexposed, sick | Adjustment: No | 1.58 [0.24;10.22] C | 2/21 3/48 | 5 | 21 |
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| S12897 R48731 |
Adams (Carbamazepine), 2022 | Verbal IQ - The Wechsler Intelligence Scale for Children, 3rd Edition (WISC-III) (mean >6 years old) | during pregnancy (anytime or not specified) | retrospective cohort | unexposed, sick | Adjustment: No extrapolated (cont. endpoint) Matched | 2.72 [1.22;6.06] | -/41 -/41 | - | 41 |
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| S15378 R63360 |
Thomas a (Carbamazepine), 2022 | Verbal IQ/Verbal comprehension index (VCI) - Wechsler Intelligence Scale for Children or Adult - Ages 13 to 21 years (mean of 16.5 ± 2.2 years) | during pregnancy (anytime or not specified) | prospective cohort | unexposed, sick | Adjustment: No extrapolated (cont. endpoint) | 2.61 [0.76;8.95] | -/38 -/11 | - | 38 |
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| S12802 R48225 |
Meador (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2021 | Language Score in 2 years old children with the Bayley Scales of Infant and Toddler Development (BSID-III) | 3rd trimester | prospective cohort | exposed to other treatment, sick excluded | Adjustment: Yes extrapolated (cont. endpoint) |
1.18 [0.40;3.52] excluded (control group) |
-/12 -/93 | - | 12 |
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| S12803 R48226 |
Meador (Carbamazepine) (Controls unexposed, disease free), 2021 | Language Score in 2 years old children with the Bayley Scales of Infant and Toddler Development (BSID-III) | 3rd trimester | prospective cohort | unexposed, disease free | Adjustment: Yes extrapolated (cont. endpoint) | 1.15 [0.39;3.45] | -/12 -/87 | - | 12 |
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| S9776 R34967 |
Coste (Carbamazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2020 | Visits to a speech therapist (mean age of 3.7 years old) | during pregnancy (anytime or not specified) | retrospective cohort (claims database) | exposed to other treatment, sick excluded | Adjustment: Yes |
0.90 [0.60;1.40] excluded (control group) |
31/502 157/2,916 | 188 | 502 |
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| S9777 R34985 |
Coste (Carbamazepine) (Controls unexposed, NOS) (Mixed indications), 2020 | Health care utilization: Speech therapy (mean age of 3.6 years old) | during pregnancy (anytime or not specified) | retrospective cohort (claims database) | unexposed (general population or NOS) | Adjustment: Yes | 1.20 [0.80;1.70] | 29/468 71,832/1,707,707 | 71,861 | 468 |
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| S9724 R34627 |
Husebye (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2020 | Language impairment age 8 years (Language 20) | during pregnancy (anytime or not specified) | population based cohort propective | exposed to other treatment, sick excluded | Adjustment: No |
2.74 [0.90;8.28] C excluded (control group) |
10/23 9/41 | 19 | 23 |
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| S9725 R34629 |
Husebye (Carbamazepine) (Controls unexposed, disease free), 2020 | Language impairment age 8 years (Language 20) | during pregnancy (anytime or not specified) | population based cohort propective | unexposed, disease free excluded | Adjustment: Yes |
3.80 [1.60;9.00] excluded (control group) |
10/23 8,250/42,550 | 8,260 | 23 |
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| S9726 R34631 |
Husebye (Carbamazepine) (Controls unexposed, sick), 2020 | Language impairment age 8 years | during pregnancy (anytime or not specified) | population based cohort propective | unexposed, sick | Adjustment: No | 2.53 [1.02;6.26] C | 10/23 35/150 | 45 | 23 |
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| S9727 R34633 |
Kasradze (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2017 | Verbal comprehension (VCI) (WPPSI-4) (mean age 4-4.5 years old) | during pregnancy (anytime or not specified) | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No extrapolated (cont. endpoint) |
0.13 [0.01;1.41] excluded (control group) |
-/16 -/3 | - | 16 |
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| S9728 R34636 |
Kasradze (Carbamazepine) (Controls unexposed, disease free), 2017 | Verbal comprehension (VCI) (WPPSI-4) (mean age 4-4.5 years old) | during pregnancy (anytime or not specified) | prospective cohort | unexposed, disease free | Adjustment: No extrapolated (cont. endpoint) Matched | 3.53 [1.24;10.04] | -/16 -/50 | - | 16 |
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| S9716 R34580 |
Deshmukh (Carbamazepine), 2016 | Vineland-II Adaptative Behavior Scales - Low and moderately low in the communication domain | throughout pregnancy | prospective cohort | exposed to other treatment, sick | Adjustment: Yes | 2.91 [0.64;13.21] | 10/97 8/104 | 18 | 97 |
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| S9937 R35715 |
Videman (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2016 | Griffiths Mental Developmental Scale - Hearing and speech (at the age of 7 months) | during pregnancy (anytime or not specified) | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No extrapolated (cont. endpoint) |
2.69 [0.46;15.78] excluded (control group) |
-/9 -/8 | - | 9 |
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| S9936 R35709 |
Videman (Carbamazepine) (Controls unexposed, disease free), 2016 | Griffiths Mental Developmental Scale - Hearing and speech (at the age of 7 months) | during pregnancy (anytime or not specified) | prospective cohort | unexposed, disease free | Adjustment: No extrapolated (cont. endpoint) | 15.07 [3.88;58.47] | -/9 -/59 | - | 9 |
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| S9691 R34479 |
Baker (Carbamazepine) (Controls exposed to Lamotrigine, sick), 2015 | Mean child verbal IQ - Differential ability scales (DAS) (age mean >6 years old) | during pregnancy (anytime or not specified) | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No extrapolated (cont. endpoint) |
1.13 [0.49;2.60] excluded (control group) |
-/50 -/29 | - | 50 |
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| S9692 R34484 |
Baker (Carbamazepine) (Controls unexposed, disease free), 2015 | Mean child verbal IQ - Differential ability scales (DAS) (age mean >6 years old) | during pregnancy (anytime or not specified) | prospective cohort | unexposed, disease free excluded | Adjustment: No extrapolated (cont. endpoint) |
2.05 [1.17;3.59] excluded (control group) |
-/50 -/210 | - | 50 |
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| S9693 R34490 |
Baker (Carbamazepine) (Controls unexposed, sick), 2015 | Mean child verbal IQ - Differential ability scales (DAS) (age mean >6 years old) | during pregnancy (anytime or not specified) | prospective cohort | unexposed, sick | Adjustment: No extrapolated (cont. endpoint) | 1.14 [0.48;2.71] | -/50 -/25 | - | 50 |
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| S9732 R34658 |
Meador (Carbamazepine), 2013 | Verbal index score (at age 6 years old) (Created by averaging standard scores) | during pregnancy (anytime or not specified) | prospective cohort | exposed to other treatment, sick | Adjustment: Yes extrapolated (cont. endpoint) | 1.19 [0.64;2.20] | -/61 -/74 | - | 61 |
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| S9733 R34670 |
Nadebaum (Carbamazepine), 2011 | Total language delay (CELF-4) (core language ≤ 85) | during pregnancy (anytime or not specified) | prospective cohort | exposed to other treatment, sick | Adjustment: No | 4.02 [0.20;78.92] C | 6/34 0/9 | 6 | 34 |
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| S9718 R34588 |
Eriksson (Carbamazepine), 2005 | Mean Verbal IQ (VIQ) (Wechsler Intelligence Scale for Children (WISC-III)) | throughout pregnancy | prospective cohort | unexposed, sick | Adjustment: No extrapolated (cont. endpoint) | 1.21 [0.30;4.90] | -/13 -/13 | - | 13 |
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| S9593 R33976 |
Adab (Carbamazepine), 2004 | Verbal IQ (VIQ) less than low average (≤ 89) (Wechsler Intelligence Scale for Children (WISC)) | during pregnancy (anytime or not specified) | retrospective cohort | unexposed, sick | Adjustment: No | 0.56 [0.27;1.14] C | 18/52 39/80 | 57 | 52 |
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| S9720 R34594 |
Gaily (Carbamazepine) (Controls unexposed, disease free), 2004 | Verbal IQ score (Wechsler Preschool and Primary Scale of Intelligence Revised (WPPSI-R) or Wechsler Intelligence Scale for Children Revised (WISC-R)) | 2nd and/or 3rd trimester | prospective cohort | unexposed, disease free excluded | Adjustment: No extrapolated (cont. endpoint) |
0.86 [0.53;1.40] excluded (control group) |
-/86 -/139 | - | 86 |
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| S9721 R34598 |
Gaily (Carbamazepine) (Controls unexposed, sick), 2004 | Verbal IQ score (WPPSI-R or WISC-R) | 2nd and/or 3rd trimester | prospective cohort | unexposed, sick | Adjustment: No extrapolated (cont. endpoint) | 0.82 [0.43;1.59] | -/86 -/44 | - | 86 |
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| Total | 19 studies | 1.59 [1.21;2.09] | 73,024 | 2,970 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| x1: number of endpoints among exposed, n1: number of exposed; x0: number of endpoints among non exposed, n0: number of non exposed; C: calculated odds ratio from numbers of events and effectives | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
1: Controls unexposed, sick) (Carbamazepine) (Epilepsy; 2: Controls unexposed, sick) (Carbamazepine) (Epilepsy; 3: Controls unexposed, general pop) (Carbamazepine) (Indication NOS; 4: Carbamazepine) (Epilepsy; 5: Carbamazepine) (Epilepsy) (Controls unexposed, sick; 6: Carbamazepine; 7: Carbamazepine; 8: Carbamazepine) (Controls unexposed, disease free; 9: Carbamazepine) (Controls unexposed, NOS) (Mixed indications; 10: Carbamazepine) (Controls unexposed, sick; 11: Carbamazepine) (Controls unexposed, disease free; 12: Carbamazepine; 13: Carbamazepine) (Controls unexposed, disease free; 14: Carbamazepine) (Controls unexposed, sick; 15: Carbamazepine; 16: Carbamazepine; 17: Carbamazepine; 18: Carbamazepine; 19: Carbamazepine) (Controls unexposed, sick;
Asymetry test p-value = 0.0804 (by Egger's regression)
slope=0.0414 (0.1810); intercept=1.1173 (0.6010); t=1.8591; p=0.0804
excluded 9720, 9691, 9692, 9937, 9727, 9776, 9724, 9725, 12802, 15367, 19338, 19389, 19377