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

Eye, ear, face and neck malformations

R analysis
id Study   Lib. in paper Exposition period    Study type 
 Control type 
 
Tags OR 95%CI x1/n1 x0/n0 no cases no exposed ROB Ref.
S6704
R18910		 Bérard - Non Sertraline SSRI, 2015 Eye, ear, face, and neck malformations 1st trimester retrospective cohort (claims database) unexposed, sick Adjustment: Yes Monotherapy: SSRI only Unexposed sick: intermediate history of illness/treatment (3-12 months before pregnancy) 0.86 [0.45;1.66] 10/1,963   86/14,868 96 1,963
ref
S6989
R19776		 Vasilakis-Scaramozza (Controls exposed to TCA), 2013 Ear, eye, face, and neck anomalies 1st trimester retrospective cohort exposed to other treatment, sick excluded Adjustment: No Monotherapy: SSRI only 0.88 [0.12;6.26] C
excluded (control group) 		2/1,825   2/1,608 4 1,825
ref
S5362
R16695		 Vasilakis-Scaramozza (Controls unexposed, NOS), 2013 Ear, eye, face, and neck anomalies 1st trimester retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: Yes Matched Monotherapy: SSRI only 0.70 [0.20;3.00] 2/1,825   12/6,617 14 1,825
ref
Total 2 studies 0.83 [0.46;1.49] 110 3,788
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

StudyTE95% CIn casesn exposedweightROBABCDEF Bérard - Non Sertraline SSRI, 2015Bérard - Non Sertraline SSRI, 2015 0.86[0.45; 1.66]961,96381%ROB confusion: seriousROB selection: moderateROB classification: criticalROB missing: unclearROB mesure: moderateROB reporting: moderate Vasilakis-Scaramozza (Controls unexposed, NOS), 2013Vasilakis-Scaramozza, 2013 1 0.70[0.20; 3.00]141,82519%ROB confusion: seriousROB selection: moderateROB classification: criticalROB missing: moderateROB mesure: moderateROB reporting: moderate Total (2 studies) I2 = 0% 0.83[0.46; 1.49]1103,7880.22.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Controls unexposed, NOS;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 0.83[0.46; 1.49]1103,7880%NABérard - Non Sertraline SSRI, 2015 Vasilakis-Scaramozza (Controls unexposed, NOS), 2013 2 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 0.70[0.18; 2.71]141,825 -NAVasilakis-Scaramozza (Controls unexposed, NOS), 2013 1 unexposed, sickunexposed, sick 0.86[0.45; 1.65]961,963 -NABérard - Non Sertraline SSRI, 2015 1 Tags Adjustment   - Yes  - Yes 0.83[0.46; 1.49]1103,7880%NABérard - Non Sertraline SSRI, 2015 Vasilakis-Scaramozza (Controls unexposed, NOS), 2013 2 MatchedMatched 0.70[0.18; 2.71]141,825 -NAVasilakis-Scaramozza (Controls unexposed, NOS), 2013 1 Monotherapy   - SSRI only  - SSRI only 0.83[0.46; 1.49]1103,7880%NABérard - Non Sertraline SSRI, 2015 Vasilakis-Scaramozza (Controls unexposed, NOS), 2013 2 Unexposed sick   - intermediate history of illness/tre ...  - intermediate history of illness/treatment (3-12 months before pregnancy) 0.86[0.45; 1.65]961,963 -NABérard - Non Sertraline SSRI, 2015 1 All studiesAll studies 0.83[0.46; 1.49]1103,7880%NABérard - Non Sertraline SSRI, 2015 Vasilakis-Scaramozza (Controls unexposed, NOS), 2013 20.210.01.0

Publication bias and p-hacking diagnosis

funnel plot

Funnel plot not drawn. Less than 3 points.

Asymetry test p-value = NaN (by Egger's regression)

not enought points

p values plot

Funnel plot not drawn. Less than 3 points.

Sub-groups analysis using all included studies

excluded 6989

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 0.70[0.18; 2.71]141,825 -NAVasilakis-Scaramozza (Controls unexposed, NOS), 2013 1 unexposed, sick controlsunexposed, sick controls 0.86[0.45; 1.65]961,963 -NABérard - Non Sertraline SSRI, 2015 1 exposed to other treatment, sick controlsexposed to other treatment, sick controls 0.88[0.12; 6.26]41,825 -NAVasilakis-Scaramozza (Controls exposed to TCA), 2013 10.510.01.0

Umbrella review (other published meta-analyses)

Published MAControlPeriodTE95% CIn exposedkI2 Huang - SSRIs (Congenital malformations of ey ...Huang - SSRIs (Congenital malformations of eye, ear, face and neck) 1.00[0.80; 1.26]26%-U,GPunexposed (general population or NOS)Anyduring pregnancy (anytime or not specified)studies TTT-9 metaPregmetaPreg 0.83[0.46; 1.49]0%3,788----Bérard - Non Sertraline SSRI, 2015 Vasilakis-Scaramozza (Controls unexposed, NOS), 2013 20.510.01.0