Levetiracetam (All indications) updated on 04-22-2025

Psychomotor developmental disorders/delay

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.
S15220
R62427		 Bromley (Levetiracetam) (Epilepsy) (Controls exposed to LTG), 2023 Motor 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 1.02 [0.31;3.43] C
excluded (control group) 		5/51   7/73 12 51
ref
S15219
R62414		 Bromley (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2023 Motor 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 1.20 [0.30;4.74] C 5/51   4/48 9 51
ref
S16612
R69683		 Thomas (Levetiracetam) (Epilepsy) (Controls exposed to LTG), 2022 Delayed motor development quotient (< 84, i.e one SD of the mean) - The developmental assessment scale for Indian infants (DASII) - Between 12-24 months of age (mean (SD): 15.3 (3.9) months)) during pregnancy (anytime or not specified) prospective cohort exposed to other treatment, sick excluded Adjustment: No 0.41 [0.02;6.81] C
excluded (control group) 		1/62   1/26 2 62
ref
S16613
R69684		 Thomas (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2022 The motor development quotient (MODQ) - The developmental assessment scale for Indian infants (DASII) - Between 12-24 months of age (mean (SD): 15.3 (3.9) months)) during pregnancy (anytime or not specified) prospective cohort unexposed, sick Adjustment: No extrapolated (cont. endpoint) 0.24 [0.13;0.43] -/62   -/110 - 62
ref
S9946
R35767		 Videman (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2016 Griffiths Mental Developmental Scale - Locomotor (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) 0.27 [0.04;1.85]
excluded (control group) 		-/7   -/8 - 7
ref
S9950
R35791		 Videman (Levetiracetam) (Controls unexposed, disease free), 2016 Griffiths Mental Developmental Scale - Locomotor (at the age of 7 months) during pregnancy (anytime or not specified) prospective cohort unexposed, disease free Adjustment: No extrapolated (cont. endpoint) 2.78 [0.66;11.65] -/7   -/59 - 7
ref
S9028
R30773		 Shallcross (Levetiracetam), 2011 Locomotor (Griffiths scale) throughout pregnancy prospective cohort unexposed, disease free Adjustment: No extrapolated (cont. endpoint) 0.75 [0.41;1.39] -/51   -/97 - 51
ref
Total 4 studies 0.76 [0.29;2.00] 9 171
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 Bromley (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2023Bromley, 2023 1 1.20[0.30; 4.74]95120%ROB confusion: criticalROB selection: moderateROB classification: moderateROB missing: moderateROB mesure: lowROB reporting: low Thomas (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2022Thomas, 2022 2 0.24[0.13; 0.43]-6230%ROB confusion: criticalROB selection: lowROB classification: moderateROB missing: unclearROB mesure: lowROB reporting: moderate Videman (Levetiracetam) (Controls unexposed, disease free), 2016Videman, 2016 3 2.78[0.66; 11.65]-720%ROB confusion: unclearROB selection: lowROB classification: moderateROB missing: criticalROB mesure: lowROB reporting: moderate Shallcross (Levetiracetam), 2011Shallcross, 2011 4 0.75[0.41; 1.39]-5130%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Total (4 studies) I2 = 79% 0.76[0.29; 2.00]91710.210.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Levetiracetam) (Epilepsy) (Controls unexposed, sick; 2: Levetiracetam) (Epilepsy) (Controls unexposed, sick; 3: Levetiracetam) (Controls unexposed, disease free; 4: Levetiracetam;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 0.76[0.29; 2.00]917179%NABromley (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2023 Thomas (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2022 Videman (Levetiracetam) (Controls unexposed, disease free), 2016 Shallcross (Levetiracetam), 2011 4 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 1.22[0.35; 4.22]-5863%NAVideman (Levetiracetam) (Controls unexposed, disease free), 2016 Shallcross (Levetiracetam), 2011 2 unexposed, sickunexposed, sick 0.47[0.10; 2.24]911377%NABromley (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2023 Thomas (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2022 2 Tags Adjustment   - No  - No 0.76[0.29; 2.00]917179%NABromley (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2023 Thomas (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2022 Videman (Levetiracetam) (Controls unexposed, disease free), 2016 Shallcross (Levetiracetam), 2011 4 extrapolated (cont. endpoint)extrapolated (cont. endpoint) 0.68[0.21; 2.17]-12085%NAThomas (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2022 Videman (Levetiracetam) (Controls unexposed, disease free), 2016 Shallcross (Levetiracetam), 2011 3 All studiesAll studies 0.76[0.29; 2.00]917179%NABromley (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2023 Thomas (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2022 Videman (Levetiracetam) (Controls unexposed, disease free), 2016 Shallcross (Levetiracetam), 2011 40.110.01.0

Publication bias and p-hacking diagnosis

funnel plot
0.0-1.71.70.8790.000Bromley (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2023Thomas (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2022Videman (Levetiracetam) (Controls unexposed, disease free), 2016Shallcross (Levetiracetam), 2011

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

not enought points

p values plot
0.01.00.01.0

Sub-groups analysis using all included studies

excluded 9946, 16612, 15220

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 1.22[0.35; 4.22]-5863%NAVideman (Levetiracetam) (Controls unexposed, disease free), 2016 Shallcross (Levetiracetam), 2011 2 unexposed, sick controlsunexposed, sick controls Out of scale0.47[0.10; 2.24]911377%NABromley (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2023 Thomas (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2022 2 exposed to other treatment, sick controlsexposed to other treatment, sick controls 0.66[0.25; 1.72]141200%NABromley (Levetiracetam) (Epilepsy) (Controls exposed to LTG), 2023 Thomas (Levetiracetam) (Epilepsy) (Controls exposed to LTG), 2022 Videman (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2016 30.510.01.0

Umbrella review (other published meta-analyses)

Published MAControlPeriodTE95% CIn exposedkI2 Veroniki b (NMA) (Psychomotor developmental delay)Veroniki b (NMA) (Psychomotor developmental delay) Out of scale0.27[0.00; 4.26]NA-Wwhatever (meta-analysis)Anyduring pregnancy (anytime or not specified)studies TTT-9 metaPregmetaPreg 0.76[0.29; 2.00]79%171----Bromley (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2023 Thomas (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2022 Videman (Levetiracetam) (Controls unexposed, disease free), 2016 Shallcross (Levetiracetam), 2011 40.510.01.0