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

Neonatal medical care

id	Study   Auto Mazzone (Levetiracetam) (Controls exposed to LTG) (Mixed indications), 2025Mazzone (Levetiracetam) (Controls unexposed, NOS) (Mixed indications), 2025Bromley (Levetiracetam) (Epilepsy) (Controls exposed to LTG), 2023Bromley (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2023Van Marter (Levetiracetam) (Controls unexposed, disease free), 2021Van Marter (Levetiracetam) (Controls unexposed, sick), 2021Aydin (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2020Aydin (Levetiracetam) (Controls unexposed, sick), 2020Bank (Levetiracetam) (Mixed indications), 2017Artama (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2013Artama (Levetiracetam) (Controls unexposed, disease free), 2013Artama (Levetiracetam) (Controls unexposed, sick), 2013	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 trimesterPaternal exp. genotoxic window only (0–3 months preconception)Paternal exposure: epigenetic window only (3–xxx months preconception)Paternal exposure: genotoxic/epigenetic window (0–xxx months preconception)Paternal exposure: other window	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.
S18702 R79560	Mazzone (Levetiracetam) (Controls exposed to LTG) (Mixed indications), 2025	Neonatal intensive care unit admission	during pregnancy (anytime or not specified)	population based cohort retrospective	exposed to other treatment, sick excluded	Adjustment: No	1.10 [0.84;1.45] C excluded (control group)	94/832   152/1,469	246	832		ref
S18703 R79568	Mazzone (Levetiracetam) (Controls unexposed, NOS) (Mixed indications), 2025	Neonatal intensive care unit admission	during pregnancy (anytime or not specified)	population based cohort retrospective	unexposed (general population or NOS)	Adjustment: Yes	1.45 [1.08;1.94]	94/832   44,768/624,794	44,862	832		ref
S15220 R62421	Bromley (Levetiracetam) (Epilepsy) (Controls exposed to LTG), 2023	Neonatal special care admission	during pregnancy (anytime or not specified)	prospective cohort	exposed to other treatment, sick excluded	Adjustment: No	0.55 [0.23;1.34] C excluded (control group)	8/70   20/106	28	70		ref
S15219 R62408	Bromley (Levetiracetam) (Epilepsy) (Controls unexposed, sick), 2023	Neonatal special care admission	during pregnancy (anytime or not specified)	prospective cohort	unexposed, sick	Adjustment: No	1.59 [0.52;4.83] C	8/70   6/80	14	70		ref
S12618 R47571	Van Marter (Levetiracetam) (Controls unexposed, disease free), 2021	Need for special care nursery or neonatal intensive care unit (NICU) admission	at least 1st trimester	prospective cohort	unexposed, disease free excluded	Adjustment: No	0.87 [0.36;2.09] C excluded (control group)	10/87   13/100	23	87		ref
S12615 R47553	Van Marter (Levetiracetam) (Controls unexposed, sick), 2021	Need for special care nursery or neonatal intensive care unit (NICU) admission	at least 1st trimester excluded	prospective cohort	unexposed, sick	Adjustment: No	0.78 [0.15;4.00] C excluded (exposition period)	10/87   2/14	12	87		ref
S8986 R30515	Aydin (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2020	Neonatal intensive care unit (NICU)	throughout pregnancy	retrospective cohort	exposed to other treatment, sick excluded	Adjustment: No	0.09 [0.00;2.41] C excluded (control group)	0/10   2/7	2	10		ref
S8987 R30525	Aydin (Levetiracetam) (Controls unexposed, sick), 2020	Neonatal intensive care unit (NICU)	throughout pregnancy	retrospective cohort	unexposed, sick	Adjustment: No	0.41 [0.02;9.43] C	0/10   2/22	2	10		ref
S9029 R30783	Bank (Levetiracetam) (Mixed indications), 2017	Admission to neonatal intensive care unit (NICU) or Special Care Nursery	during pregnancy (anytime or not specified)	prospective cohort	exposed to other treatment, sick	Adjustment: No	0.83 [0.08;8.24] C	1/7   6/36	7	7		ref
S8983 R30476	Artama (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2013	Admission to neonatal care unit	3rd trimester	population based cohort retrospective	exposed to other treatment, sick excluded	Adjustment: No	1.08 [0.22;5.26] C excluded (control group)	2/12   24/154	26	12		ref
S8984 R30488	Artama (Levetiracetam) (Controls unexposed, disease free), 2013	Admission to neonatal care unit	3rd trimester	population based cohort retrospective	unexposed, disease free excluded	Adjustment: Yes	2.37 [0.52;10.92] excluded (control group)	2/12   49,612/689,482	49,614	12		ref
S8985 R30500	Artama (Levetiracetam) (Controls unexposed, sick), 2013	Admission to neonatal care unit	3rd trimester	population based cohort retrospective	unexposed, sick	Adjustment: Yes	1.86 [0.39;8.92]	2/12   152/1,708	154	12		ref
					Total	5 studies	1.44 [1.10;1.90]		45,039	931
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 8983, 8984, 8986, 12618, 15220, 18702