Fluoxetine updated on 07-01-2025

Neonatal death (< 28 days of life)

id	Study   Auto Lee (Controls exposed to TCAs), 2025Lee (Controls unexposed, general pop), 2025Stephansson, 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.
S18436 R78156	Lee (Controls exposed to TCAs), 2025	Neonatal death (≤28 days after birth)	during pregnancy (anytime or not specified)	retrospective cohort (claims database)	exposed to other treatment, sick excluded	Adjustment: No Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...)	2.56 [0.10;62.98] C excluded (control group)	1/719   0/613	1	719		ref
S18415 R77851	Lee (Controls unexposed, general pop), 2025	Neonatal death (≤28 days after birth)	during pregnancy (anytime or not specified)	retrospective cohort (claims database)	unexposed (general population or NOS)	Adjustment: Yes Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...)	0.94 [0.12;7.09]	1/719   627/463,440	628	719		ref
S7923 R23973	Stephansson, 2013	Neonatal death (death within 0-27 days among live born infants)	3 months (or more) before pregnancy or during pregnancy excluded	population based cohort retrospective	unexposed (general population or NOS)	Adjustment: No Monotherapy: no or not specified	1.14 [0.69;1.89] C excluded (exposition period)	15/5,976   3,535/1,604,649	3,550	5,976		ref
					Total	1 studies	0.94 [0.12;7.23]		628	719
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 18436