Lamotrigine (Epilepsy) updated on 04-22-2025

Severe cognitive developmental delay (Mental retardation) (3-6 years old)

R analysis
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.
S19477
R83182		 Straub (Lamotrigine) (Epilepsy), 2026 Intellectual disability - ICD-10 codes: F70-F79 - Mean follow up (full cohort): 3.4 years during pregnancy (anytime or not specified) retrospective cohort (claims database) unexposed, sick Adjustment: Yes 2.46 [1.16;5.24] 12/3,273   26/8,887 38 3,273
ref
S12723
R73453		 Bjørk (Controls unexposed, NOS), 2022 Diagnosis of intellectual disability (ID): mild ID (F70), moderate ID (F71), severe ID (F72), and profound ID (F73) - Median follow up lamotrigine 5.1 (2.4-8.5) years old during pregnancy (anytime or not specified) population based cohort retrospective unexposed (general population or NOS) excluded Adjustment: No 1.13 [0.73;1.73] C
excluded (control group) 		21/5,073   16,384/4,463,879 16,405 5,073
ref
S12722
R73452		 Bjørk (Controls unexposed, sick), 2022 Diagnosis of intellectual disability (ID): mild ID (F70), moderate ID (F71), severe ID (F72), and profound ID (F73) - Median follow up lamotrigine 5.1 (2.4-8.5) years old during pregnancy (anytime or not specified) population based cohort retrospective unexposed, sick Adjustment: Yes 0.73 [0.46;1.16] 21/5,073   139/21,634 160 5,073
ref
S6940
R25096		 Cummings, 2011 Significant delay (score ≥2 SD below the mean) (Bayley Scales of Infant Development or the Griffiths Scale) (mean age in years: m1=2.7 and m0=4.3) throughout pregnancy retrospective cohort (registry) unexposed, disease free Adjustment: No 0.41 [0.02;10.40] C 0/35   1/44 1 35
ref
Total 3 studies 1.16 [0.41;3.32] 199 8,381
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

Forest plot

StudyTE95% CIn casesn exposedweightROBABCDEF Straub (Lamotrigine) (Epilepsy), 2026Straub, 2026 1 2.46[1.16; 5.24]383,27342%ROB confusion: seriousROB selection: lowROB classification: moderateROB missing: unclearROB mesure: criticalROB reporting: moderate Bjørk (Controls unexposed, sick), 2022Bjørk, 2022 2 0.73[0.46; 1.16]1605,07349%ROB confusion: seriousROB selection: lowROB classification: criticalROB missing: lowROB mesure: moderateROB reporting: moderate Cummings, 2011Cummings, 2011 0.41[0.02; 10.40]1359%ROB confusion: criticalROB selection: lowROB classification: moderateROB missing: unclearROB mesure: lowROB reporting: moderate Total (3 studies) I2 = 73% 1.16[0.41; 3.32]1998,3810.25.01.0ROB: A: confounding, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Lamotrigine) (Epilepsy; 2: Controls unexposed, sick;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 1.16[0.41; 3.32]1998,38173%NAStraub (Lamotrigine) (Epilepsy), 2026 Bjørk (Controls unexposed, sick), 2022 Cummings, 2011 3 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 0.41[0.02; 10.40]135 -NACummings, 2011 1 unexposed, sickunexposed, sick 1.29[0.39; 4.23]1988,34686%NAStraub (Lamotrigine) (Epilepsy), 2026 Bjørk (Controls unexposed, sick), 2022 2 Tags Adjustment   - No  - No 0.41[0.02; 10.40]135 -NACummings, 2011 1   - Yes  - Yes 1.29[0.39; 4.23]1988,34686%NAStraub (Lamotrigine) (Epilepsy), 2026 Bjørk (Controls unexposed, sick), 2022 2 All studiesAll studies 1.16[0.41; 3.32]1998,38173%NAStraub (Lamotrigine) (Epilepsy), 2026 Bjørk (Controls unexposed, sick), 2022 Cummings, 2011 30.25.01.0

Publication bias and p-hacking diagnosis

funnel plot

Funnel plot not drawn. Less than 3 points.

Asymetry test p-value = NaN (by Egger's regression)

not enought points

p values plot

Funnel plot not drawn. Less than 3 points.

Sub-groups analysis using all included studies

excluded 12723

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 1.11[0.72; 1.70]16,4065,1080%NABjørk (Controls unexposed, NOS), 2022 Cummings, 2011 2 unexposed, sick controlsunexposed, sick controls 1.29[0.39; 4.23]1988,34686%NAStraub (Lamotrigine) (Epilepsy), 2026 Bjørk (Controls unexposed, sick), 2022 20.510.01.0

Umbrella review (other published meta-analyses)

Published MAControlPeriodTE95% CIn exposedkI2 Peron (Epilepsy) (Severe cognitive developmen ...Peron (Epilepsy) (Severe cognitive developmental delay (3-6 years old)) Out of scale0.41[0.02; 10.40]NA-Wwhatever (meta-analysis)Anyduring pregnancy (anytime or not specified)studies TTT1 metaPregmetaPreg 1.16[0.41; 3.32]73%8,381----Straub (Lamotrigine) (Epilepsy), 2026 Bjørk (Controls unexposed, sick), 2022 Cummings, 2011 30.510.01.0