Selective Serotonin Reuptake Inhibitor (SSRI) updated on 07-01-2025

Minor congenital malformations

id	Study   Auto Richardson, 2019Manakova, 2011Wen, 2006Casper, 2003Simon (Controls exposed to TCA), 2002Simon (Controls unexposed, NOS), 2002Chambers - Fluoxetine, 1996	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.
S7479 R22391	Richardson, 2019	Minor congenital malformations (genetic conditions excluded)	during pregnancy (anytime or not specified) excluded	prospective cohort	unexposed (general population or NOS)	Adjustment: No Monotherapy: no or not specified	1.13 [0.63;2.04] C excluded (exposition period)	19/843   28/1,400	47	843		ref
S7579 R23160	Manakova, 2011	Minor malformations	1st trimester	prospective cohort	unexposed (general population or NOS)	Adjustment: No Monotherapy: no or not specified	5.24 [0.21;131.37] C	1/47   0/80	1	47		ref
S5405 R16048	Wen, 2006	Minor structural anomalies	3 months (or more) before pregnancy or during pregnancy excluded	retrospective cohort (claims database)	unexposed (general population or NOS)	Adjustment: Yes Matched Monotherapy: no or not specified	1.02 [0.69;1.51] excluded (exposition period)	35/972   133/3,878	168	972		ref
S510 R15167	Casper, 2003	Minor structural anomalies	during pregnancy (anytime or not specified) excluded	prospective cohort	unexposed, sick	Adjustment: No Monotherapy: no or not specified Unexposed sick: recent illness/treatment (during or juste before pregnancy or treatment stopped in view of pregnancy)	2.94 [0.74;11.65] C excluded (exposition period)	24/31   7/13	31	31		ref
S6994 R19834	Simon (Controls exposed to TCA), 2002	Minor malformations	during pregnancy (anytime or not specified)	retrospective cohort (claims database)	exposed to other treatment, sick excluded	Adjustment: No Monotherapy: SSRI only	1.50 [0.72;3.11] C excluded (control group)	18/185   14/209	32	185		ref
S492 R17422	Simon (Controls unexposed, NOS), 2002	Minor malformations	during pregnancy (anytime or not specified) excluded	retrospective cohort (claims database)	unexposed (general population or NOS)	Adjustment: No Matched Monotherapy: SSRI only	1.14 [0.56;2.30] excluded (exposition period)	18/185   16/185	34	185		ref
S490 R15183	Chambers - Fluoxetine, 1996	Minor structural anomalies (>= 3)	1st trimester	prospective cohort	unexposed (general population or NOS)	Adjustment: No Monotherapy: no or not specified	2.62 [1.12;6.09] C	15/97   10/153	25	97		ref
					Total	2 studies	2.74 [1.21;6.19]		26	144
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 6994

Umbrella review (other published meta-analyses)