Duloxetine updated on 07-01-2025

Major congenital malformations

id	Study   Auto Ankarfeldt a (Controls unexposed, NOS), 2021Ankarfeldt a (Controls unexposed, sick), 2021Anderson, 2020Bahat, 2020Huybrechts (Controls unexposed, NOS), 2020Huybrechts (Controls unexposed, sick), 2020Ozturk, 2016Källen, 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.
S11682 R42906	Ankarfeldt a (Controls unexposed, NOS), 2021	Major malformations	1st trimester	population based cohort retrospective	unexposed (general population or NOS) excluded	Adjustment: Yes Monotherapy: no or not specified	0.96 [0.75;1.24] excluded (control group)	63/1,430   75,879/1,965,441	75,942	1,430		ref
S11683 R42922	Ankarfeldt a (Controls unexposed, sick), 2021	Major malformations	1st trimester	population based cohort retrospective	unexposed, sick	Adjustment: Yes Monotherapy: no or not specified Unexposed sick: intermediate history of illness/treatment (3-12 months before pregnancy)	0.91 [0.66;1.24]	63/1,430   130/2,766	193	1,430		ref
S11768 R43246	Anderson, 2020	Major birth defects	1st trimester	case control	unexposed (general population or NOS)	Adjustment: No Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...)	2.06 [0.71;5.98] C	22/26   30,608/42,082	30,630	26		ref
S11708 R43061	Bahat, 2020	Major congenital anomalies	1st trimester	prospective cohort	unexposed (general population or NOS)	Adjustment: Yes Monotherapy: no or not specified	1.02 [0.33;3.15]	5/128   20/511	25	128		ref
S11747 R43155	Huybrechts (Controls unexposed, NOS), 2020	Major congenital malformations overall	1st trimester	retrospective cohort (claims database)	unexposed (general population or NOS) excluded	Adjustment: Yes Monotherapy: no or not specified	1.11 [0.93;1.33] excluded (control group)	128/2,532   47,001/1,284,827	47,129	2,532		ref
S11748 R43176	Huybrechts (Controls unexposed, sick), 2020	Major congenital malformations overall	1st trimester	retrospective cohort (claims database)	unexposed, sick	Adjustment: Yes Monotherapy: no or not specified Unexposed sick: intermediate history of illness/treatment (3-12 months before pregnancy)	1.09 [0.84;1.42]	128/2,532   114/2,456	242	2,532		ref
S11788 R43369	Ozturk, 2016	Major congenital defects	at least 1st trimester	prospective cohort	unexposed (general population or NOS)	Adjustment: No Monotherapy: no or not specified	13.86 [0.56;344.93] C	0/3   3/246	3	3		ref
S11837 R43451	Källen, 2013	Relatively severe malformations	early pregnancy	population based cohort retrospective	unexposed (general population or NOS)	Adjustment: Yes Monotherapy: no or not specified	0.80 [0.32;1.64]	7/286   -/-	-	286		ref
					Total	6 studies	1.03 [0.84;1.27]		31,093	4,405
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 11747, 11682