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

Major congenital malformations

id	Study   Auto Battino (Epilepsy), 2024The Australian Pregnancy Register of Antiepileptic Drugs (Mixed indications) (Controls exposed to LTG), 2024The Australian Pregnancy Register of Antiepileptic Drugs (Mixed indications) (Controls unexposed, sick), 2024The Kerala Registry for Epilepsy and Pregnancy (Epilepsy) (Controls exposed to Lamotrigine), 2024The Kerala Registry for Epilepsy and Pregnancy (Epilepsy) (Controls unexposed, sick), 2024The NAAED (Controls exposed to LTG) (Indications NOS), 2024The NAAED (Controls unexposed, disease free) (Indications NOS), 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 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.
S16583 R69647	Battino (Epilepsy), 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
S17213 R72104	The Australian Pregnancy Register of Antiepileptic Drugs (Mixed indications) (Controls exposed to LTG), 2024	Major congenital malformations	at least 1st trimester	prospective cohort	exposed to other treatment, sick excluded	Adjustment: No	6.27 [0.25;158.67] C excluded (control group)	0/2   20/406	20	2		ref
S17214 R72106	The Australian Pregnancy Register of Antiepileptic Drugs (Mixed indications) (Controls unexposed, sick), 2024	Major congenital malformations	at least 1st trimester	prospective cohort	unexposed, sick	Adjustment: No	8.87 [0.33;236.26] C	0/2   7/207	7	2		ref
S17194 R72052	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
S17195 R72062	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
S16193 R67086	The NAAED (Controls exposed to LTG) (Indications NOS), 2024	Major congenital malformations	1st trimester	prospective cohort	exposed to other treatment, sick excluded	Adjustment: No	0.25 [0.02;4.05] C excluded (control group)	0/93   52/2,461	52	93		ref
S16183 R67075	The NAAED (Controls unexposed, disease free) (Indications NOS), 2024	Major congenital malformations	1st trimester	prospective cohort	unexposed, disease free	Adjustment: No	0.45 [0.03;7.61] C	0/93   15/1,311	15	93		ref
S17186 R72034	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
S17187 R72036	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
S17217 R72112	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
S17218 R72114	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	5 studies	1.55 [0.41;5.79]		161	137
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 17213, 17194, 16193, 17186, 17217