| 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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| S19385 R82314 |
Honybun (Lamotrigine) (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) | 2.39 [0.78;7.32] | -/23 -/19 | - | 23 |
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| S19394 R82400 |
Li (Lamotrigine) (Epilepsy), 2026 | Verbal domain - The Differential Ability Scales–2nd Edition (DAS-II) - At 6 years old | during pregnancy (anytime or not specified) | prospective cohort | unexposed, disease free | Adjustment: Yes extrapolated (cont. endpoint) | 0.51 [0.30;0.89] | -/90 -/79 | - | 90 |
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| S19371 R82154 |
Straub (Lamotrigine) (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 [0.86;1.26] | 175/3,273 456/8,887 | 631 | 3,273 |
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| S19332 R82035 |
Moore (Lamotrigine) (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 | 1.63 [1.37;1.95] C | 172/934 1,134/9,335 | 1,306 | 934 |
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| S15218 R62400 |
Bromley (Lamotrigine) (Epilepsy), 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 | 0.87 [0.19;4.07] C | 4/73 3/48 | 7 | 73 |
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| S8978 R30441 |
Coste (Lamotrigine) (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 [1.00;1.40] | 149/2,813 71,832/1,707,707 | 71,981 | 2,813 |
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| S8947 R30244 |
Husebye (Lamotrigine) (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 |
1.20 [0.60;2.60] excluded (control group) |
9/41 8,250/42,550 | 8,259 | 41 |
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| S8949 R30249 |
Husebye (Lamotrigine) (Controls unexposed, sick), 2020 | Language impairment age 8 years (Language 20) | during pregnancy (anytime or not specified) | population based cohort propective | unexposed, sick | Adjustment: No | 0.92 [0.40;2.12] C | 9/41 35/150 | 44 | 41 |
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| S8941 R30226 |
Cohen-Israel (Lamotrigine), 2018 | Speech delay (a majority between 6-12 years old) | 1st trimester | retrospective cohort | unexposed, disease free | Adjustment: No Matched | 0.35 [0.13;0.96] C | 6/83 15/83 | 21 | 83 |
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| S8950 R30251 |
Kasradze (Lamotrigine), 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 | 22.98 [2.54;207.85] | -/3 -/50 | - | 3 |
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| S9947 R35775 |
Videman (Lamotrigine), 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) | 2.39 [0.62;9.19] | -/8 -/59 | - | 8 |
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| S8929 R30171 |
Baker (Lamotrigine) (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) |
1.82 [0.90;3.68] excluded (control group) |
-/29 -/210 | - | 29 |
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| S8930 R30176 |
Baker (Lamotrigine) (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) | 1.00 [0.38;2.64] | -/29 -/25 | - | 29 |
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| S8952 R30278 |
Rihtman (Lamotrigine), 2013 | Stanford Binet Intelligence Scales, Fifth Edition (SB5) - Verbal IQ (VIQ) (mean age 4-5 years old) | at least 1st trimester | prospective cohort | unexposed (general population or NOS) | Adjustment: No extrapolated (cont. endpoint) | 1.42 [0.67;2.98] | -/41 -/52 | - | 41 |
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| Total | 12 studies | 1.14 [0.87;1.48] | 73,990 | 7,411 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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: Lamotrigine) (Epilepsy; 2: Lamotrigine) (Epilepsy; 3: Lamotrigine) (Epilepsy; 4: Lamotrigine) (Indication NOS; 5: Lamotrigine) (Epilepsy; 6: Lamotrigine) (Controls unexposed NOS) (Mixed indications; 7: Lamotrigine) (Controls unexposed, sick; 8: Lamotrigine; 9: Lamotrigine; 10: Lamotrigine; 11: Lamotrigine) (Controls unexposed, sick; 12: Lamotrigine;
Asymetry test p-value = 0.8222 (by Egger's regression)
slope=0.2344 (0.1433); intercept=-0.1921 (0.8325); t=0.2307; p=0.8222
excluded 8929, 8947