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

Cognitive developmental disorders/delay (< 3 years old)

id	Study   Auto Ertürk Çetin (Epilepsy) (Levetiracetam), 2024Bromley (Levetiracetam) (Epilepsy) (Controls exposed to LTG), 2023Bromley (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2023Thomas (Levetiracetam) (Epilepsy) (Controls exposed to LTG), 2022Thomas (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2022Videman (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2016Videman (Levetiracetam) (Controls unexposed, disease free), 2016Shallcross (Levetiracetam), 2011	Lib. in paper	Exposition period  Auto during pregnancy (anytime or not specified)1st trimester2nd trimester3rd trimester2nd and/or 3rd trimesterthroughout pregnancyearly pregnancydays before deliverylate pregnancypreconception-onlypericonceptionalpreconceptional for kinetic reasonat least 1st trimester3 months (or more) before pregnancy or during pregnancy1st and 2nd trimester3 months or more before pregnancy or1st trimester	Study type  All studies Case control excluded Only case control	Control type    Auto unexposed (general population or NOS)unexposed, sickunexposed, disease freeexposed to other treatment, sicknot specifiedsiblingwhatever (meta-analysis)	Tags	OR 95%CI	x1/n1 x0/n0	no cases	no exposed	ROB	Ref.
S16804 R70507	Ertürk Çetin (Epilepsy) (Levetiracetam), 2024	Developmental delay in one domain - The Denver Developmental Screening Test (DDST) - At 18 month of age	throughout pregnancy	prospective cohort	exposed to other treatment, sick	Adjustment: No	0.43 [0.01;23.69] C	0/18   0/8	0	18		ref
S15220 R62425	Bromley (Levetiracetam) (Epilepsy) (Controls exposed to LTG), 2023	Cognitive mean score ≤ 88 (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	3.86 [0.72;20.73] C excluded (control group)	5/51   2/73	7	51		ref
S15219 R62412	Bromley (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2023	Cognitive mean score ≤ 88 (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	2.50 [0.46;13.55] C	5/51   2/48	7	51		ref
S16612 R69682	Thomas (Levetiracetam) (Epilepsy) (Controls exposed to LTG), 2022	The mental development quotient (MEDQ) - 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 extrapolated (cont. endpoint)	0.43 [0.19;1.00] excluded (control group)	-/62   -/26	-	62		ref
S16613 R69685	Thomas (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2022	The mental development quotient (MEDQ) - 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)	0.49 [0.28;0.87]	-/62   -/110	-	62		ref
S9946 R53769	Videman (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2016	Griffiths Mental Developmental Scale - General quotient (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)	0.73 [0.12;4.63] excluded (control group)	-/7   -/8	-	7		ref
S9950 R53770	Videman (Levetiracetam) (Controls unexposed, disease free), 2016	Griffiths Mental Developmental Scale - General quotient (at the age of 7 months)	during pregnancy (anytime or not specified)	prospective cohort	unexposed, disease free	Adjustment: No extrapolated (cont. endpoint)	3.30 [0.79;13.90]	-/7   -/59	-	7		ref
S9028 R53768	Shallcross (Levetiracetam), 2011	Overall development quotient (Griffiths scale) <84	throughout pregnancy	prospective cohort	unexposed, disease free	Adjustment: No	0.60 [0.18;1.97] C	4/51   12/97	16	51		ref
					Total	5 studies	0.97 [0.41;2.30]		23	189
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

Sensitivity analysis

Publication bias and p-hacking diagnosis

Sub-groups analysis using all included studies

excluded 9946, 16612, 15220