Fluoxetine updated on 07-01-2025

Ventricular septal defect

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.
S7469
R22212
Anderson, 2020 Ventricular septal defect (VSD) – perimembranous type 1st trimester case control unexposed (general population or NOS) Adjustment: Yes Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...) 1.00 [0.53;1.89] -/-   0/- - -
ref
S7349
R21463
Wemakor, 2015 Ventricular septal defect 1st trimester case control unexposed (general population or NOS) Adjustment: Yes Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...) 0.97 [0.47;2.02] 10/37   6,157/23,213 6,167 37
ref
S6102
R15926
Huybrechts (Controls unexposed, NOS), 2014 Ventricular Septal Defect 1st trimester cohort unexposed (general population or NOS) excluded Adjustment: No Monotherapy: no or not specified 1.20 [0.90;1.59]
excluded (control group)
48/11,048   3,212/885,115 3,260 11,048
ref
S6103
R15930
Huybrechts (Controls unexposed, sick), 2014 Ventricular Septal Defect 1st trimester cohort unexposed, sick Adjustment: Yes Monotherapy: no or not specified Unexposed sick: old history of illness/treatment (> 12 months before pregnancy) or not specified 1.04 [0.74;1.46] 41/8,676   751/180,563 792 8,676
ref
S6016
R15530
Jimenez-Solem (Controls unexposed, NOS), 2012 Ventricular septal defects 1st trimester population based cohort retrospective unexposed (general population or NOS) excluded Adjustment: Yes Monotherapy: substance alone among the specific class of antidep (SSRI, SNRI, ...) 1.03 [0.33;3.20]
excluded (control group)
3/928   2,803/843,797 2,806 928
ref
S6021
R15612
Jimenez-Solem (Controls unexposed, sick), 2012 Ventricular septal defects 1st trimester population based cohort retrospective unexposed, sick Adjustment: No Monotherapy: substance alone among the specific class of antidep (SSRI, SNRI, ...) Unexposed sick: intermediate history of illness/treatment (3-12 months before pregnancy) 0.29 [0.08;1.06] C 3/928   9/806 12 928
ref
S6242
R16491
Malm, 2011 Ventricular septal defects 1st trimester population based cohort retrospective unexposed (general population or NOS) Adjustment: Yes Monotherapy: no or not specified 1.49 [1.00;2.20] 26/1,818   5,465/628,607 5,491 1,818
ref
Total 5 studies 1.06 [0.77;1.46] 12,462 11,459
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 Anderson, 2020Anderson, 2020 1.00[0.53; 1.89]--17%ROB confusion: seriousROB selection: criticalROB classification: criticalROB missing: lowROB mesure: unclearROB reporting: moderate Wemakor, 2015Wemakor, 2015 0.97[0.47; 2.02]6,1673714%ROB confusion: criticalROB selection: criticalROB classification: moderateROB missing: lowROB mesure: moderateROB reporting: moderate Huybrechts (Controls unexposed, sick), 2014Huybrechts, 2014 1 1.04[0.74; 1.46]7928,67634%ROB confusion: moderateROB selection: lowROB classification: moderateROB missing: moderateROB mesure: moderateROB reporting: moderate Jimenez-Solem (Controls unexposed, sick), 2012Jimenez-Solem, 2012 2 0.29[0.08; 1.06]129285%ROB confusion: criticalROB selection: moderateROB classification: criticalROB missing: lowROB mesure: moderateROB reporting: critical Malm, 2011Malm, 2011 1.49[1.00; 2.20]5,4911,81830%ROB confusion: criticalROB selection: lowROB classification: moderateROB missing: lowROB mesure: criticalROB reporting: moderate Total (5 studies) I2 = 39% 1.06[0.77; 1.46]12,46211,4590.25.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Controls unexposed, sick; 2: Controls unexposed, sick;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 1.03[0.60; 1.75]6,29511,42268%NAHuybrechts (Controls unexposed, sick), 2014 Jimenez-Solem (Controls unexposed, sick), 2012 Malm, 2011 3 case control studiescase control studies 0.99[0.61; 1.59]6,167370%NAAnderson, 2020 Wemakor, 2015 2 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 1.26[0.93; 1.71]11,6581,8550%NAAnderson, 2020 Wemakor, 2015 Malm, 2011 3 unexposed, sickunexposed, sick 0.64[0.19; 2.18]8049,60471%NAHuybrechts (Controls unexposed, sick), 2014 Jimenez-Solem (Controls unexposed, sick), 2012 2 Tags Adjustment   - No  - No 0.29[0.08; 1.06]12928 -NAJimenez-Solem (Controls unexposed, sick), 2012 1   - Yes  - Yes 1.16[0.92; 1.45]12,45010,5310%NAAnderson, 2020 Wemakor, 2015 Huybrechts (Controls unexposed, sick), 2014 Malm, 2011 4 Monotherapy   - no or not specified  - no or not specified 1.23[0.86; 1.74]6,28310,49445%NAHuybrechts (Controls unexposed, sick), 2014 Malm, 2011 2   - substance alone among all Antidep ( ...  - substance alone among all Antidep (SSRI, SNRI, ...) 0.99[0.61; 1.59]6,167370%NAAnderson, 2020 Wemakor, 2015 2   - substance alone among the specific ...  - substance alone among the specific class of antidep (SSRI, SNRI, ...) 0.29[0.08; 1.06]12928 -NAJimenez-Solem (Controls unexposed, sick), 2012 1 Unexposed sick   - intermediate history of illness/tre ...  - intermediate history of illness/treatment (3-12 months before pregnancy) 0.29[0.08; 1.06]12928 -NAJimenez-Solem (Controls unexposed, sick), 2012 1   - old history of illness/treatment (> ...  - old history of illness/treatment (> 12 months before pregnancy) or not specified 1.04[0.74; 1.46]7928,676 -NAHuybrechts (Controls unexposed, sick), 2014 1 All studiesAll studies 1.06[0.77; 1.46]12,46211,45939%NAAnderson, 2020 Wemakor, 2015 Huybrechts (Controls unexposed, sick), 2014 Jimenez-Solem (Controls unexposed, sick), 2012 Malm, 2011 50.15.01.0

Publication bias and p-hacking diagnosis

funnel plot
0.0-1.61.60.8020.000Anderson, 2020Wemakor, 2015Huybrechts (Controls unexposed, sick), 2014Jimenez-Solem (Controls unexposed, sick), 2012Malm, 2011

Asymetry test p-value = 0.1684 (by Egger's regression)

slope=0.5955 (0.2951); intercept=-2.0927 (1.1579); t=1.8073; p=0.1684

p values plot
0.01.00.01.0

Sub-groups analysis using all included studies

excluded 6016, 6102

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 1.22[1.00; 1.50]17,72413,8310%NAAnderson, 2020 Wemakor, 2015 Huybrechts (Controls unexposed, NOS), 2014 Jimenez-Solem (Controls unexposed, NOS), 2012 Malm, 2011 5 unexposed, sick controlsunexposed, sick controls 0.64[0.19; 2.18]8049,60471%NAHuybrechts (Controls unexposed, sick), 2014 Jimenez-Solem (Controls unexposed, sick), 2012 20.510.01.0

Umbrella review (other published meta-analyses)

Published MAControlPeriodTE95% CIn exposedkI2 Reefhuis (Ventricular septal defects)Reefhuis (Ventricular septal defects) 1.40[1.00; 1.90]NA-Wwhatever (meta-analysis)Anyduring pregnancy (anytime or not specified)studies TTT2 metaPregmetaPreg 1.06[0.77; 1.46]39%11,459----Anderson, 2020 Wemakor, 2015 Huybrechts (Controls unexposed, sick), 2014 Jimenez-Solem (Controls unexposed, sick), 2012 Malm, 2011 50.510.01.0