Paroxetine updated on 07-01-2025

Urinary 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.
S7434
R21895		 Bérard, 2017 Urinary system 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) 0.47 [0.19;1.14] -/1,132   -/14,847 - 1,132
ref
S8216
R25612		 Jordan, 2016 Urinary 3 months or more before pregnancy or1st trimester excluded retrospective cohort (registry) unexposed (general population or NOS) Adjustment: No Monotherapy: no or not specified 1.59 [0.66;3.82] C
excluded (exposition period) 		5/1,069   1,496/506,155 1,501 1,069
ref
S5886
R14748		 Ban (Controls unexposed, disease free), 2014 Urinary system malformations 1st trimester retrospective cohort (claims database) unexposed, disease free Adjustment: Yes Monotherapy: substance alone among the specific class of antidep (SSRI, SNRI, ...) 0.99 [0.32;3.10] -/1,200   815/325,294 - 1,200
ref
S6017
R15555		 Jimenez-Solem (Controls unexposed, NOS), 2012 Congenital malformations of the internal urinary system 1st trimester population based cohort retrospective unexposed (general population or NOS) Adjustment: No Monotherapy: substance alone among the specific class of antidep (SSRI, SNRI, ...) 0.32 [0.02;5.09] C 0/568   2,333/843,797 2,333 568
ref
S7228
R20765		 Davis, 2007 Congenital anomalies of urinary system 1st trimester retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: No Monotherapy: no or not specified 0.29 [0.02;4.63] C 0/182   470/49,654 470 182
ref
S6160
R16178		 Louik, 2007 Renal-collecting-system defects 1st trimester case control unexposed (general population or NOS) Adjustment: Yes Monotherapy: substance alone among the specific class of antidep (SSRI, SNRI, ...) 1.00 [0.20;2.60] 4/34   640/6,470 644 34
ref
Total 5 studies 0.65 [0.36;1.16] 3,447 3,116
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 0.47[0.19; 1.14]-1,13243%ROB confusion: seriousROB selection: moderateROB classification: criticalROB missing: lowROB mesure: moderateROB reporting: moderate Ban (Controls unexposed, disease free), 2014Ban, 2014 1 0.99[0.32; 3.10]-1,20027%ROB confusion: seriousROB selection: moderateROB classification: criticalROB missing: lowROB mesure: criticalROB reporting: moderate Jimenez-Solem (Controls unexposed, NOS), 2012Jimenez-Solem, 2012 2 0.32[0.02; 5.09]2,3335684%ROB confusion: criticalROB selection: moderateROB classification: criticalROB missing: lowROB mesure: moderateROB reporting: critical Davis, 2007Davis, 2007 0.29[0.02; 4.63]4701824%ROB confusion: criticalROB selection: moderateROB classification: criticalROB missing: lowROB mesure: moderateROB reporting: moderate Louik, 2007Louik, 2007 1.00[0.20; 2.60]6443421%ROB confusion: moderateROB selection: criticalROB classification: criticalROB missing: lowROB mesure: criticalROB reporting: moderate Total (5 studies) I2 = 0% 0.65[0.36; 1.16]3,4473,1160.22.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Controls unexposed, disease free; 2: Controls unexposed, NOS;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 0.58[0.30; 1.12]2,8033,0820%NABérard, 2017 Ban (Controls unexposed, disease free), 2014 Jimenez-Solem (Controls unexposed, NOS), 2012 Davis, 2007 4 case control studiescase control studies 1.00[0.28; 3.61]64434 -NALouik, 2007 1 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 0.82[0.38; 1.80]3,4471,9840%NABan (Controls unexposed, disease free), 2014 Jimenez-Solem (Controls unexposed, NOS), 2012 Davis, 2007 Louik, 2007 4 unexposed, sickunexposed, sick 0.47[0.19; 1.15]-1,132 -NABérard, 2017 1 Tags Adjustment   - No  - No 0.30[0.04; 2.15]2,8037500%NAJimenez-Solem (Controls unexposed, NOS), 2012 Davis, 2007 2   - Yes  - Yes 0.70[0.38; 1.29]6442,3660%NABérard, 2017 Ban (Controls unexposed, disease free), 2014 Louik, 2007 3 Monotherapy   - no or not specified  - no or not specified 0.29[0.02; 4.63]470182 -NADavis, 2007 1   - substance alone among all Antidep ( ...  - substance alone among all Antidep (SSRI, SNRI, ...) 0.47[0.19; 1.15]-1,132 -NABérard, 2017 1   - substance alone among the specific ...  - substance alone among the specific class of antidep (SSRI, SNRI, ...) 0.90[0.40; 2.03]2,9771,8020%NABan (Controls unexposed, disease free), 2014 Jimenez-Solem (Controls unexposed, NOS), 2012 Louik, 2007 3 Unexposed sick   - intermediate history of illness/tre ...  - intermediate history of illness/treatment (3-12 months before pregnancy) 0.47[0.19; 1.15]-1,132 -NABérard, 2017 1 All studiesAll studies 0.65[0.36; 1.16]3,4473,1160%NABérard, 2017 Ban (Controls unexposed, disease free), 2014 Jimenez-Solem (Controls unexposed, NOS), 2012 Davis, 2007 Louik, 2007 50.110.01.0

Publication bias and p-hacking diagnosis

funnel plot
0.0-3.32.91.7000.000Bérard, 2017Ban (Controls unexposed, disease free), 2014Jimenez-Solem (Controls unexposed, NOS), 2012Davis, 2007Louik, 2007

Asymetry test p-value = 0.6286 (by Egger's regression)

slope=-0.1368 (0.6052); intercept=-0.4841 (0.9017); t=0.5369; p=0.6286

p values plot
0.01.00.01.0

Sub-groups analysis using all included studies

excluded

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 0.82[0.38; 1.80]4,2531,9840%NABan (Controls unexposed, disease free), 2014 Jimenez-Solem (Controls unexposed, NOS), 2012 Davis, 2007 Louik, 2007 4 unexposed, sick controlsunexposed, sick controls Out of scale0.47[0.19; 1.15]-1,132 -NABérard, 2017 10.510.01.0