Fluoxetine updated on 07-01-2025

Genital anomalies

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.
S7438
R21944		 Bérard, 2017 Genital organs malformations 1st trimester retrospective cohort (claims database) unexposed, sick Adjustment: Yes Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...) Unexposed sick: intermediate history of illness/treatment (3-12 months before pregnancy) 0.50 [0.07;3.35] -/191   -/14,847 - 191
ref
S5882
R14692		 Ban (Controls unexposed, disease free), 2014 Genital system malformations 1st trimester retrospective cohort (claims database) unexposed, disease free excluded Adjustment: Yes Monotherapy: substance alone among the specific class of antidep (SSRI, SNRI, ...) 0.38 [0.16;0.93]
excluded (control group) 		-/3,189   1,292/325,294 - 3,189
ref
S5883
R14713		 Ban (Controls unexposed, sick), 2014 Genital system malformations 1st trimester retrospective cohort (claims database) unexposed, sick Adjustment: Yes Monotherapy: substance alone among the specific class of antidep (SSRI, SNRI, ...) Unexposed sick: intermediate history of illness/treatment (3-12 months before pregnancy) 0.31 [0.12;0.76] -/3,189   67/13,432 - 3,189
ref
S10218
R37435		 De Jonge, 2013 Genital malformations 1st trimester case control unexposed (general population or NOS) Adjustment: No Monotherapy: no or not specified 0.71 [0.04;11.50] C 0/65   314/29,472 314 65
ref
S6016
R15534		 Jimenez-Solem (Controls unexposed, NOS), 2012 Congenital malformations of the external genital organs 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, ...) 1.09 [0.35;3.38]
excluded (control group) 		3/928   2,504/843,797 2,507 928
ref
S6021
R15615		 Jimenez-Solem (Controls unexposed, sick), 2012 Congenital malformations of the external genital organs 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) 1.30 [0.22;7.82] C 3/928   2/806 5 928
ref
Total 4 studies 0.45 [0.21;0.92] 319 4,373
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, 2017Bérard, 2017 0.50[0.07; 3.35]-19114%ROB confusion: seriousROB selection: moderateROB classification: criticalROB missing: lowROB mesure: moderateROB reporting: moderate Ban (Controls unexposed, sick), 2014Ban, 2014 1 0.31[0.12; 0.76]-3,18962%ROB confusion: seriousROB selection: moderateROB classification: criticalROB missing: lowROB mesure: criticalROB reporting: moderate De Jonge, 2013De Jonge, 2013 0.71[0.04; 11.50]314657%ROB confusion: criticalROB selection: criticalROB classification: criticalROB missing: lowROB mesure: moderateROB reporting: moderate Jimenez-Solem (Controls unexposed, sick), 2012Jimenez-Solem, 2012 2 1.30[0.22; 7.82]592817%ROB confusion: criticalROB selection: moderateROB classification: criticalROB missing: lowROB mesure: moderateROB reporting: critical Total (4 studies) I2 = 0% 0.45[0.21; 0.92]3194,3730.25.01.0ROB: 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 0.43[0.20; 0.92]54,3080%NABérard, 2017 Ban (Controls unexposed, sick), 2014 Jimenez-Solem (Controls unexposed, sick), 2012 3 case control studiescase control studies 0.71[0.04; 11.50]31465 -NADe Jonge, 2013 1 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 0.71[0.04; 11.50]31465 -NADe Jonge, 2013 1 unexposed, sickunexposed, sick 0.43[0.20; 0.92]54,3080%NABérard, 2017 Ban (Controls unexposed, sick), 2014 Jimenez-Solem (Controls unexposed, sick), 2012 3 Tags Adjustment   - No  - No 1.09[0.24; 4.92]3199930%NADe Jonge, 2013 Jimenez-Solem (Controls unexposed, sick), 2012 2   - Yes  - Yes 0.34[0.15; 0.78]-3,3800%NABérard, 2017 Ban (Controls unexposed, sick), 2014 2 Monotherapy   - no or not specified  - no or not specified 0.71[0.04; 11.50]31465 -NADe Jonge, 2013 1   - substance alone among all Antidep ( ...  - substance alone among all Antidep (SSRI, SNRI, ...) 0.50[0.07; 3.46]-191 -NABérard, 2017 1   - substance alone among the specific ...  - substance alone among the specific class of antidep (SSRI, SNRI, ...) 0.51[0.13; 1.97]54,11749%NABan (Controls unexposed, sick), 2014 Jimenez-Solem (Controls unexposed, sick), 2012 2 Unexposed sick   - intermediate history of illness/tre ...  - intermediate history of illness/treatment (3-12 months before pregnancy) 0.43[0.20; 0.92]54,3080%NABérard, 2017 Ban (Controls unexposed, sick), 2014 Jimenez-Solem (Controls unexposed, sick), 2012 3 All studiesAll studies 0.45[0.21; 0.92]3194,3730%NABérard, 2017 Ban (Controls unexposed, sick), 2014 De Jonge, 2013 Jimenez-Solem (Controls unexposed, sick), 2012 40.15.01.0

Publication bias and p-hacking diagnosis

funnel plot
0.0-3.32.51.7050.000Bérard, 2017Ban (Controls unexposed, sick), 2014De Jonge, 2013Jimenez-Solem (Controls unexposed, sick), 2012

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

not enought points

p values plot
0.01.00.01.0

Sub-groups analysis using all included studies

excluded 6016, 5882

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 0.58[0.29; 1.17]4,1044,1825%NABan (Controls unexposed, disease free), 2014 De Jonge, 2013 Jimenez-Solem (Controls unexposed, NOS), 2012 3 unexposed, sick controlsunexposed, sick controls Out of scale0.43[0.20; 0.92]634,3080%NABérard, 2017 Ban (Controls unexposed, sick), 2014 Jimenez-Solem (Controls unexposed, sick), 2012 30.510.01.0