| 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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| S19390 R82364 |
Honybun (Controls exposed to LTG) (Levetiracetam) (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) |
2.43 [0.81;7.33] excluded (control group) |
-/20 -/23 | - | 20 |
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| S19386 R82324 |
Honybun (Controls unexposed, sick) (Levetiracetam) (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) | 5.97 [1.77;20.09] | -/20 -/19 | - | 20 |
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| S19396 R82410 |
Li (Controls exposed to LTG) (Levetiracetam) (Epilepsy), 2026 | Verbal domain - The Differential Ability Scales–2nd Edition (DAS-II) - At 6 years old | during pregnancy (anytime or not specified) | prospective cohort | exposed to other treatment, sick excluded | Adjustment: Yes extrapolated (cont. endpoint) |
1.44 [0.82;2.52] excluded (control group) |
-/73 -/90 | - | 73 |
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| S19395 R82405 |
Li (Controls unexposed, disease free) (Levetiracetam) (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) | 0.80 [0.45;1.42] | -/73 -/79 | - | 73 |
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| S19378 R82258 |
Straub (Controls exposed to LTG) (Levetiracetam) (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 |
0.82 [0.66;1.02] C excluded (control group) |
174/3,929 175/3,273 | 349 | 3,929 |
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| S19369 R82122 |
Straub (Controls unexposed, sick) (Levetiracetam) (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 | 0.96 [0.79;1.16] | 174/3,929 456/8,887 | 630 | 3,929 |
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| S18021 R76053 |
Bhaskaran (Levetiracetam) (Epilepsy), 2025 | Speech delay - Expressive language age on Receptive–Expressive Emergent Language Scale (REELS) < 70 - Infants ages of 1.5 to 2.5 years | during pregnancy (anytime or not specified) | prospective cohort | unexposed, disease free | Adjustment: No | 1.14 [0.21;6.29] | 2/10 9/50 | 11 | 10 |
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| S19339 R82017 |
Moore (Controls exposed to LTG) (Levetiracetam) (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 |
0.89 [0.67;1.18] C excluded (control group) |
88/527 172/934 | 260 | 527 |
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| S19333 R82038 |
Moore (Controls unexposed, general pop) (Levetiracetam) (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 | 1.44 [1.13;1.83] C | 88/527 645/5,268 | 733 | 527 |
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| S16562 R69601 |
Stjerna (Levetiracetam) (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) | 0.88 [0.33;2.34] | -/16 -/74 | - | 16 |
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| S15220 R62426 |
Bromley (Levetiracetam) (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 |
1.88 [0.48;7.35] C excluded (control group) |
5/51 4/73 | 9 | 51 |
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| S15219 R62413 |
Bromley (Levetiracetam) (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 | 1.63 [0.37;7.23] C | 5/51 3/48 | 8 | 51 |
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| S10071 R36657 |
Coste (Levetiracetam) (Controls exposed to Lamotrigine, sick), 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 |
0.70 [0.40;1.10] excluded (control group) |
22/621 122/2,108 | 144 | 621 |
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| S9020 R30718 |
Coste (Levetiracetam) (Controls unexposed, NOS), 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 | 0.80 [0.60;1.30] | 22/621 72,012/1,710,441 | 72,034 | 621 |
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| S9023 R30763 |
Husebye (Levetiracetam) (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 |
0.71 [0.07;6.89] C excluded (control group) |
1/6 9/41 | 10 | 6 |
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| S9024 R30765 |
Husebye (Levetiracetam) (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 |
0.70 [0.10;6.00] excluded (control group) |
1/6 8,250/42,550 | 8,251 | 6 |
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| S9025 R30767 |
Husebye (Levetiracetam) (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 | 0.66 [0.07;5.81] C | 1/6 35/150 | 36 | 6 |
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| S9018 R30670 |
Bromley (Levetiracetam), 2016 | Verbal abilities <85 (Wechsler Preschool and Primary Scale of Intelligence (WPPSI) / Wechsler Intelligence Scale for Children (WISC)) (5-9 years old) | during pregnancy (anytime or not specified) | retrospective cohort (registry) | unexposed, sick | Adjustment: No | 0.31 [0.03;2.89] C | 1/42 4/55 | 5 | 42 |
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| S9946 R35769 |
Videman (Levetiracetam) (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) |
1.00 [0.16;6.30] excluded (control group) |
-/7 -/8 | - | 7 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9950 R35793 |
Videman (Levetiracetam) (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) | 2.61 [0.62;10.93] | -/7 -/59 | - | 7 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S9028 R30775 |
Shallcross (Levetiracetam), 2011 | Hearing and language (Griffiths scale) | throughout pregnancy | prospective cohort | unexposed, disease free | Adjustment: No extrapolated (cont. endpoint) | 1.09 [0.59;2.01] | -/51 -/97 | - | 51 |
|
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| Total | 12 studies | 1.10 [0.86;1.42] | 73,457 | 5,353 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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) (Levetiracetam) (Epilepsy; 2: Controls unexposed, disease free) (Levetiracetam) (Epilepsy; 3: Controls unexposed, sick) (Levetiracetam) (Epilepsy; 4: Levetiracetam) (Epilepsy; 5: Controls unexposed, general pop) (Levetiracetam) (Indication NOS; 6: Levetiracetam) (Epilepsy; 7: Levetiracetam) (Epilepsy) (Controls unexposed, sick; 8: Levetiracetam) (Controls unexposed, NOS; 9: Levetiracetam) (Controls unexposed, sick; 10: Levetiracetam; 11: Levetiracetam) (Controls unexposed, disease free; 12: Levetiracetam;
Asymetry test p-value = 0.7199 (by Egger's regression)
slope=0.0370 (0.1427); intercept=0.2303 (0.6243); t=0.3689; p=0.7199
excluded 9946, 10071, 9023, 9024, 15220, 19339, 19390, 19396, 19378