Paroxetine 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.
S7434
R21894		 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) 0.79 [0.41;1.52] -/1,132   -/14,847 - 1,132
ref
S5886
R14747		 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, ...) 0.97 [0.40;2.37]
excluded (control group) 		-/1,200   1,292/325,294 - 1,200
ref
S5887
R14762		 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) 0.81 [0.32;2.02] -/1,200   67/13,432 - 1,200
ref
S6017
R15556		 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, ...) 3.83 [1.71;8.57]
excluded (control group) 		6/568   2,504/843,797 2,510 568
ref
S6022
R15623		 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) 4.29 [0.86;21.34] C 6/568   2/806 8 568
ref
S7228
R20764		 Davis, 2007 Congenital anomalies of genital organs 1st trimester retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: No Monotherapy: no or not specified 0.43 [0.11;1.71] 2/182   1,166/49,654 1,168 182
ref
Total 4 studies 0.90 [0.46;1.76] 1,176 3,082
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 0.79[0.41; 1.52]-1,13240%ROB confusion: seriousROB selection: moderateROB classification: criticalROB missing: lowROB mesure: moderateROB reporting: moderate Ban (Controls unexposed, sick), 2014Ban, 2014 1 0.81[0.32; 2.02]-1,20029%ROB confusion: seriousROB selection: moderateROB classification: criticalROB missing: lowROB mesure: criticalROB reporting: moderate Jimenez-Solem (Controls unexposed, sick), 2012Jimenez-Solem, 2012 2 4.29[0.86; 21.34]856814%ROB confusion: criticalROB selection: moderateROB classification: criticalROB missing: lowROB mesure: moderateROB reporting: critical Davis, 2007Davis, 2007 0.43[0.11; 1.71]1,16818217%ROB confusion: criticalROB selection: moderateROB classification: criticalROB missing: lowROB mesure: moderateROB reporting: moderate Total (4 studies) I2 = 39% 0.90[0.46; 1.76]1,1763,0820.210.01.0ROB: 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 0.90[0.46; 1.76]1,1763,08239%NABérard, 2017 Ban (Controls unexposed, sick), 2014 Jimenez-Solem (Controls unexposed, sick), 2012 Davis, 2007 4 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 0.43[0.11; 1.70]1,168182 -NADavis, 2007 1 unexposed, sickunexposed, sick 1.07[0.49; 2.34]82,90048%NABérard, 2017 Ban (Controls unexposed, sick), 2014 Jimenez-Solem (Controls unexposed, sick), 2012 3 Tags Adjustment   - No  - No 1.31[0.14; 12.44]1,17675078%NAJimenez-Solem (Controls unexposed, sick), 2012 Davis, 2007 2   - Yes  - Yes 0.80[0.47; 1.36]-2,3320%NABérard, 2017 Ban (Controls unexposed, sick), 2014 2 Monotherapy   - no or not specified  - no or not specified 0.43[0.11; 1.70]1,168182 -NADavis, 2007 1   - substance alone among all Antidep ( ...  - substance alone among all Antidep (SSRI, SNRI, ...) 0.79[0.41; 1.52]-1,132 -NABérard, 2017 1   - substance alone among the specific ...  - substance alone among the specific class of antidep (SSRI, SNRI, ...) 1.63[0.32; 8.18]81,76868%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) 1.07[0.49; 2.34]82,90048%NABérard, 2017 Ban (Controls unexposed, sick), 2014 Jimenez-Solem (Controls unexposed, sick), 2012 3 All studiesAll studies 0.90[0.46; 1.76]1,1763,08239%NABérard, 2017 Ban (Controls unexposed, sick), 2014 Jimenez-Solem (Controls unexposed, sick), 2012 Davis, 2007 40.210.01.0

Publication bias and p-hacking diagnosis

funnel plot
0.0-1.91.80.9820.000Bérard, 2017Ban (Controls unexposed, sick), 2014Jimenez-Solem (Controls unexposed, sick), 2012Davis, 2007

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 6017, 5886

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 1.27[0.37; 4.37]4,9611,95078%NABan (Controls unexposed, disease free), 2014 Jimenez-Solem (Controls unexposed, NOS), 2012 Davis, 2007 3 unexposed, sick controlsunexposed, sick controls 1.07[0.49; 2.34]662,90048%NABérard, 2017 Ban (Controls unexposed, sick), 2014 Jimenez-Solem (Controls unexposed, sick), 2012 30.510.01.0