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

Cleft lip with or without cleft palate

id	Study   Auto Kim (Controls exposed to LTG) (Carbamazepine) (Indications NOS), 2026Kim (Controls unexposed, NOS) (Carbamazepine) (Indications NOS), 2026Blotière (Carbamazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2019Blotière (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019Vajda (Carbamazepine) (Controls unexposed, sick), 2013Jentink (Carbamazepine), 2010Viinikainen (Carbamazepine) (Controls unexposed, sick) a, 2006Artama (Carbamazepine), 2005	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.
S19320 R81875	Kim (Controls exposed to LTG) (Carbamazepine) (Indications NOS), 2026	Cleft lip with or without cleft palate	1st trimester	population based cohort retrospective	exposed to other treatment, sick excluded	Adjustment: No	1.68 [0.10;26.98] C excluded (control group)	1/427   1/718	2	427		ref
S19312 R81770	Kim (Controls unexposed, NOS) (Carbamazepine) (Indications NOS), 2026	Cleft lip with or without cleft palate	1st trimester	population based cohort retrospective	unexposed (general population or NOS)	Adjustment: Yes	2.64 [0.29;23.67]	1/427   1,910/2,489,078	1,911	427		ref
S10176 R37259	Blotière (Carbamazepine) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2019	Cleft lip with or without cleft palate	1st trimester	retrospective cohort (claims database)	exposed to other treatment, sick excluded	Adjustment: No	1.17 [0.06;24.43] C excluded (control group)	0/512   2/2,997	2	512		ref
S9766 R34909	Blotière (Carbamazepine) (Controls unexposed NOS) (Mixed indications), 2019	Cleft lip with or without cleft palate	1st trimester	retrospective cohort (claims database)	unexposed (general population or NOS)	Adjustment: No	1.12 [0.07;17.92] C	0/512   1,637/1,875,733	1,637	512		ref
S10291 R37677	Vajda (Carbamazepine) (Controls unexposed, sick), 2013	Palate/lip malformation	at least 1st trimester	prospective cohort	unexposed, sick	Adjustment: No	0.41 [0.01;20.58] C	0/361   0/147	0	361		ref
S9664 R34409	Jentink (Carbamazepine), 2010	Cleft lip (with or without palate)	1st trimester	case control	unexposed (general population or NOS)	Adjustment: Yes	no data	1/-   -/-	-	-		ref
S9648 R34335	Viinikainen (Carbamazepine) (Controls unexposed, sick) a, 2006	Cleft lip	throughout pregnancy	prospective cohort	unexposed, sick	Adjustment: No	2.19 [0.09;54.89] C	1/72   0/52	1	72		ref
S9652 R34349	Artama (Carbamazepine), 2005	Cleft lip/ cleft palate	1st trimester	retrospective cohort (registry)	unexposed, sick	Adjustment: No	0.23 [0.01;4.86] C	0/805   2/939	2	805		ref
					Total	6 studies	1.13 [0.31;4.08]		3,551	2,177
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 10176, 19320

Umbrella review (other published meta-analyses)