Paroxetine updated on 07-01-2025

Nervous system 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
R21889		 Bérard, 2017 Nervous 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) 1.34 [0.74;2.42] -/1,132   -/14,847 - 1,132
ref
S5886
R14751		 Ban (Controls unexposed, disease free), 2014 Nervous system malformations 1st trimester retrospective cohort (claims database) unexposed, disease free Adjustment: No Monotherapy: substance alone among the specific class of antidep (SSRI, SNRI, ...) 0.29 [0.02;4.66] C 0/1,200   465/325,294 465 1,200
ref
S10219
R37438		 De Jonge, 2013 Central nervous system anomalies 1st trimester case control unexposed (general population or NOS) Adjustment: No Monotherapy: no or not specified 0.39 [0.02;6.21] C 0/181   208/29,250 208 181
ref
S6017
R15558		 Jimenez-Solem (Controls unexposed, NOS), 2012 Malformations of the nervous system 1st trimester population based cohort retrospective unexposed (general population or NOS) Adjustment: Yes Monotherapy: substance alone among the specific class of antidep (SSRI, SNRI, ...) 1.19 [0.17;8.45] 1/568   -/843,797 - 568
ref
S7180
R20239		 Colvin, 2011 Nervous system defects 1st trimester retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: No Monotherapy: substance alone among the specific class of antidep (SSRI, SNRI, ...) 0.28 [0.02;4.57] C 0/572   289/94,561 289 572
ref
S6243
R16506		 Malm, 2011 Central nervous system 1st trimester population based cohort retrospective unexposed (general population or NOS) Adjustment: Yes Monotherapy: no or not specified 0.32 [0.05;2.27] -/968   -/628,607 - 968
ref
Total 6 studies 1.03 [0.62;1.73] 962 4,621
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 1.34[0.74; 2.42]-1,13275%ROB confusion: seriousROB selection: moderateROB classification: criticalROB missing: lowROB mesure: moderateROB reporting: moderate Ban (Controls unexposed, disease free), 2014Ban, 2014 1 0.29[0.02; 4.66]4651,2003%ROB confusion: seriousROB selection: moderateROB classification: criticalROB missing: lowROB mesure: criticalROB reporting: moderate De Jonge, 2013De Jonge, 2013 0.39[0.02; 6.21]2081813%ROB confusion: criticalROB selection: criticalROB classification: criticalROB missing: lowROB mesure: moderateROB reporting: moderate Jimenez-Solem (Controls unexposed, NOS), 2012Jimenez-Solem, 2012 2 1.19[0.17; 8.45]-5687%ROB confusion: criticalROB selection: moderateROB classification: criticalROB missing: lowROB mesure: moderateROB reporting: critical Colvin, 2011Colvin, 2011 0.28[0.02; 4.57]2895723%ROB confusion: criticalROB selection: moderateROB classification: criticalROB missing: unclearROB mesure: moderateROB reporting: moderate Malm, 2011Malm, 2011 0.32[0.05; 2.27]-9687%ROB confusion: criticalROB selection: lowROB classification: criticalROB missing: lowROB mesure: criticalROB reporting: moderate Total (6 studies) I2 = 0% 1.03[0.62; 1.73]9624,6210.25.01.0ROB: 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 1.07[0.63; 1.80]7544,4400%NABérard, 2017 Ban (Controls unexposed, disease free), 2014 Jimenez-Solem (Controls unexposed, NOS), 2012 Colvin, 2011 Malm, 2011 5 case control studiescase control studies 0.39[0.02; 6.21]208181 -NADe Jonge, 2013 1 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 0.46[0.16; 1.31]9623,4890%NABan (Controls unexposed, disease free), 2014 De Jonge, 2013 Jimenez-Solem (Controls unexposed, NOS), 2012 Colvin, 2011 Malm, 2011 5 unexposed, sickunexposed, sick 1.34[0.74; 2.42]-1,132 -NABérard, 2017 1 Tags Adjustment   - No  - No 0.32[0.06; 1.58]9621,9530%NABan (Controls unexposed, disease free), 2014 De Jonge, 2013 Colvin, 2011 3   - Yes  - Yes 1.18[0.69; 2.04]-2,6680%NABérard, 2017 Jimenez-Solem (Controls unexposed, NOS), 2012 Malm, 2011 3 Monotherapy   - no or not specified  - no or not specified 0.34[0.07; 1.64]2081,1490%NADe Jonge, 2013 Malm, 2011 2   - substance alone among all Antidep ( ...  - substance alone among all Antidep (SSRI, SNRI, ...) 1.34[0.74; 2.42]-1,132 -NABérard, 2017 1   - substance alone among the specific ...  - substance alone among the specific class of antidep (SSRI, SNRI, ...) 0.59[0.15; 2.34]7542,3400%NABan (Controls unexposed, disease free), 2014 Jimenez-Solem (Controls unexposed, NOS), 2012 Colvin, 2011 3 Unexposed sick   - intermediate history of illness/tre ...  - intermediate history of illness/treatment (3-12 months before pregnancy) 1.34[0.74; 2.42]-1,132 -NABérard, 2017 1 All studiesAll studies 1.03[0.62; 1.73]9624,6210%NABérard, 2017 Ban (Controls unexposed, disease free), 2014 De Jonge, 2013 Jimenez-Solem (Controls unexposed, NOS), 2012 Colvin, 2011 Malm, 2011 60.15.01.0

Publication bias and p-hacking diagnosis

funnel plot
0.0-3.33.41.7010.000Bérard, 2017Ban (Controls unexposed, disease free), 2014De Jonge, 2013Jimenez-Solem (Controls unexposed, NOS), 2012Colvin, 2011Malm, 2011

Asymetry test p-value = 0.0204 (by Egger's regression)

slope=0.6716 (0.2151); intercept=-1.2446 (0.3344); t=3.7219; p=0.0204

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) Out of scale0.46[0.16; 1.31]9623,4890%NABan (Controls unexposed, disease free), 2014 De Jonge, 2013 Jimenez-Solem (Controls unexposed, NOS), 2012 Colvin, 2011 Malm, 2011 5 unexposed, sick controlsunexposed, sick controls 1.34[0.74; 2.42]-1,132 -NABérard, 2017 10.510.01.0