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

Congenital heart defects

id	Study   Auto Seo (Lamotrigine) (Epilepsy), 2026Wiggs (Epilepsy) (Lamotrigine), 2024Cohen (Lamotrigine) (Mixed indications), 2023Thomas (Lamotrigine) (Controls unexposed, sick), 2021Diav-Citrin (Lamotrigine), 2017Ban (Lamotrigine) (Mixed indications), 2015Vajda (Lamotrigine), 2013Mawer (Lamotrigine) (Controls unexposed, disease free), 2010Mawer (Lamotrigine) (Controls unexposed, sick), 2010	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.
S19361 R82068	Seo (Lamotrigine) (Epilepsy), 2026	Congenital Heart Defects	1st trimester	population based cohort retrospective	unexposed, sick	Adjustment: Yes	1.10 [0.61;1.99]	-/-   -/-	-	-		ref
S17498 R73508	Wiggs (Epilepsy) (Lamotrigine), 2024	Circulatory system malformations	early pregnancy	population based cohort retrospective	unexposed, sick	Adjustment: Yes	0.94 [0.64;1.38]	-/1,412   -/9,364	-	1,412		ref
S15197 R62329	Cohen (Lamotrigine) (Mixed indications), 2023	Cardiac system malformation	1st trimester	population based cohort retrospective	unexposed (general population or NOS)	Adjustment: Yes Partial overlapping	0.96 [0.81;1.13]	-/8,339   -/4,866,362	-	8,339		ref
S8924 R48249	Thomas (Lamotrigine) (Controls unexposed, sick), 2021	Cardiac malformations	1st trimester	prospective cohort	unexposed, sick	Adjustment: No	0.75 [0.09;6.05] C	1/50   9/340	10	50		ref
S8920 R35918	Diav-Citrin (Lamotrigine), 2017	Cardiovascular anomalies without chromosomal anomalies	at least 1st trimester	prospective cohort	unexposed, disease free	Adjustment: No	2.46 [0.66;9.22] C	3/114   9/828	12	114		ref
S8969 R30374	Ban (Lamotrigine) (Mixed indications), 2015	Heart anomaly	1st trimester	prospective cohort	unexposed (general population or NOS)	Adjustment: Yes	3.33 [1.25;8.89]	7/273   2,041/257,153	2,048	273		ref
S10292 R37689	Vajda (Lamotrigine), 2013	Cardiac Malformations	at least 1st trimester	prospective cohort	unexposed, sick	Adjustment: No	1.40 [0.14;13.61] C	3/315   1/147	4	315		ref
S8909 R35287	Mawer (Lamotrigine) (Controls unexposed, disease free), 2010	Cardiac Malformations	1st trimester	prospective cohort	unexposed, disease free excluded	Adjustment: No Matched	2.59 [0.10;64.75] C excluded (control group)	0/37   1/285	1	37		ref
S8910 R35291	Mawer (Lamotrigine) (Controls unexposed, sick), 2010	Cardiac Malformations	1st trimester	prospective cohort	unexposed, sick	Adjustment: No Matched	1.11 [0.02;57.36] C	0/37   0/41	0	37		ref
					Total	8 studies	1.06 [0.85;1.32]		2,074	10,540
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 8909

Umbrella review (other published meta-analyses)