Lacosamide (Epilepsy) updated on 04-22-2025

Major congenital malformations

id	Study   Auto The NAAED (Lacosamide) (Epilepsy), 2025Battino, 2024The Kerala Registry for Epilepsy and Pregnancy (Epilepsy) (Controls exposed to Lamotrigine), 2024The Kerala Registry for Epilepsy and Pregnancy (Epilepsy) (Controls unexposed, sick), 2024The UKIEPR (Epilepsy) (Controls exposed to Lamotrigine), 2024The UKIEPR (Epilepsy) (Controls unexposed, sick), 2024The West China Registry (Epilepsy) (Controls exposed to LTG), 2024The West China Registry (Epilepsy) (Controls unexposed, sick), 2024	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.
S18714 R79621	The NAAED (Lacosamide) (Epilepsy), 2025	Major congenital malformations	1st trimester	prospective cohort	exposed to other treatment, sick	Adjustment: No	0.27 [0.02;4.51] C	0/86   40/1,944	40	86		ref
S16708 R70293	Battino, 2024	Major congenital malformations (MCMs)	early pregnancy	prospective cohort	exposed to other treatment, sick	Adjustment: No	0.52 [0.03;8.48] C	0/31   110/3,584	110	31		ref
S17198 R72074	The Kerala Registry for Epilepsy and Pregnancy (Epilepsy) (Controls exposed to Lamotrigine), 2024	Major congenital malformations	1st trimester	prospective cohort	exposed to other treatment, sick excluded	Adjustment: No	2.94 [0.11;81.30] C excluded (control group)	0/6   1/50	1	6		ref
S17199 R72076	The Kerala Registry for Epilepsy and Pregnancy (Epilepsy) (Controls unexposed, sick), 2024	Major congenital malformations	1st trimester	prospective cohort	unexposed, sick	Adjustment: No	1.78 [0.09;33.62] C	0/6   16/340	16	6		ref
S17188 R72038	The UKIEPR (Epilepsy) (Controls exposed to Lamotrigine), 2024	Major malformations	1st trimester	prospective cohort	exposed to other treatment, sick excluded	Adjustment: No	4.60 [0.24;86.58] C excluded (control group)	0/5   49/2,098	49	5		ref
S17189 R72040	The UKIEPR (Epilepsy) (Controls unexposed, sick), 2024	Major malformations	1st trimester	prospective cohort	unexposed, sick	Adjustment: No	4.34 [0.22;84.74] C	0/5   13/541	13	5		ref
S17219 R72116	The West China Registry (Epilepsy) (Controls exposed to LTG), 2024	Major congenital malformation	during pregnancy (anytime or not specified)	prospective cohort	exposed to other treatment, sick excluded	Adjustment: No	8.33 [0.15;473.61] C excluded (control group)	0/5   0/38	0	5		ref
S17220 R72118	The West China Registry (Epilepsy) (Controls unexposed, sick), 2024	Major congenital malformation	during pregnancy (anytime or not specified) excluded	prospective cohort	unexposed, sick	Adjustment: No	3.64 [0.18;73.84] C excluded (exposition period)	0/5   7/253	7	5		ref
					Total	4 studies	0.97 [0.23;4.07]		179	128
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 17198, 17188, 17219