Paroxetine updated on 07-01-2025

Limb defects

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.
S7470
R22274		 Anderson, 2020 Any limb deficiency 1st trimester case control unexposed (general population or NOS) Adjustment: Yes Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...) 1.59 [0.71;3.54] -/-   0/- - -
ref
S7434
R21896		 Bérard, 2017 Musculoskeletal system 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) 1.01 [0.75;1.37] -/1,132   -/14,847 - 1,132
ref
S5886
R14746		 Ban (Controls unexposed, disease free), 2014 Limb malformations 1st trimester retrospective cohort (claims database) unexposed, disease free excluded Adjustment: Yes Monotherapy: substance alone among the specific class of antidep (SSRI, SNRI, ...) 0.92 [0.41;2.06]
excluded (control group) 		-/1,200   1,750/325,294 - 1,200
ref
S5887
R14761		 Ban (Controls unexposed, sick), 2014 Limb 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) 0.94 [0.41;2.15] -/1,200   71/13,432 - 1,200
ref
S10219
R37441		 De Jonge, 2013 Limb malformations 1st trimester case control unexposed (general population or NOS) Adjustment: No Monotherapy: no or not specified 0.44 [0.03;7.02] C 0/181   184/29,226 184 181
ref
S6017
R15557		 Jimenez-Solem (Controls unexposed, NOS), 2012 Congenital malformations of the limbs 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, ...) 0.91 [0.43;1.92]
excluded (control group) 		7/568   11,785/843,797 11,792 568
ref
S6022
R15624		 Jimenez-Solem (Controls unexposed, sick), 2012 Congenital malformations of the limbs 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) 0.71 [0.28;1.76] C 7/568   14/806 21 568
ref
S7180
R20246		 Colvin, 2011 Musculoskeletal defects (ICD 754–756) 1st trimester retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: No Monotherapy: substance alone among the specific class of antidep (SSRI, SNRI, ...) 0.47 [0.15;1.46] -/572   1,052/94,561 - 572
ref
S6243
R16513		 Malm, 2011 Musculoskeletal malformations (including limb defects) 1st trimester population based cohort retrospective unexposed (general population or NOS) Adjustment: Yes Monotherapy: no or not specified 1.11 [0.61;2.02] -/968   -/628,607 - 968
ref
Total 7 studies 1.00 [0.79;1.25] 205 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 Anderson, 2020Anderson, 2020 1.59[0.71; 3.54]--8%ROB confusion: seriousROB selection: criticalROB classification: criticalROB missing: lowROB mesure: unclearROB reporting: moderate Bérard, 2017Bérard, 2017 1.01[0.75; 1.37]-1,13258%ROB confusion: seriousROB selection: moderateROB classification: criticalROB missing: lowROB mesure: moderateROB reporting: moderate Ban (Controls unexposed, sick), 2014Ban, 2014 1 0.94[0.41; 2.15]-1,2008%ROB confusion: seriousROB selection: moderateROB classification: criticalROB missing: lowROB mesure: criticalROB reporting: moderate De Jonge, 2013De Jonge, 2013 0.44[0.03; 7.02]1841811%ROB confusion: criticalROB selection: criticalROB classification: criticalROB missing: lowROB mesure: moderateROB reporting: moderate Jimenez-Solem (Controls unexposed, sick), 2012Jimenez-Solem, 2012 2 0.71[0.28; 1.76]215686%ROB confusion: criticalROB selection: moderateROB classification: criticalROB missing: lowROB mesure: moderateROB reporting: critical Colvin, 2011Colvin, 2011 0.47[0.15; 1.46]-5724%ROB confusion: criticalROB selection: moderateROB classification: criticalROB missing: unclearROB mesure: moderateROB reporting: moderate Malm, 2011Malm, 2011 1.11[0.61; 2.02]-96815%ROB confusion: criticalROB selection: lowROB classification: criticalROB missing: lowROB mesure: criticalROB reporting: moderate Total (7 studies) I2 = 0% 1.00[0.79; 1.25]2054,6210.25.01.0ROB: 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 0.96[0.76; 1.22]214,4400%NABérard, 2017 Ban (Controls unexposed, sick), 2014 Jimenez-Solem (Controls unexposed, sick), 2012 Colvin, 2011 Malm, 2011 5 case control studiescase control studies 1.44[0.67; 3.11]1841810%NAAnderson, 2020 De Jonge, 2013 2 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 1.05[0.65; 1.70]1841,72111%NAAnderson, 2020 De Jonge, 2013 Colvin, 2011 Malm, 2011 4 unexposed, sickunexposed, sick 0.97[0.74; 1.27]212,9000%NABérard, 2017 Ban (Controls unexposed, sick), 2014 Jimenez-Solem (Controls unexposed, sick), 2012 3 Tags Adjustment   - No  - No 0.59[0.30; 1.18]2051,3210%NADe Jonge, 2013 Jimenez-Solem (Controls unexposed, sick), 2012 Colvin, 2011 3   - Yes  - Yes 1.06[0.83; 1.36]-3,3000%NAAnderson, 2020 Bérard, 2017 Ban (Controls unexposed, sick), 2014 Malm, 2011 4 Monotherapy   - no or not specified  - no or not specified 1.06[0.59; 1.91]1841,1490%NADe Jonge, 2013 Malm, 2011 2   - substance alone among all Antidep ( ...  - substance alone among all Antidep (SSRI, SNRI, ...) 1.08[0.79; 1.48]-1,1327%NAAnderson, 2020 Bérard, 2017 2   - substance alone among the specific ...  - substance alone among the specific class of antidep (SSRI, SNRI, ...) 0.73[0.42; 1.25]212,3400%NABan (Controls unexposed, sick), 2014 Jimenez-Solem (Controls unexposed, sick), 2012 Colvin, 2011 3 Unexposed sick   - intermediate history of illness/tre ...  - intermediate history of illness/treatment (3-12 months before pregnancy) 0.97[0.74; 1.27]212,9000%NABérard, 2017 Ban (Controls unexposed, sick), 2014 Jimenez-Solem (Controls unexposed, sick), 2012 3 All studiesAll studies 1.00[0.79; 1.25]2054,6210%NAAnderson, 2020 Bérard, 2017 Ban (Controls unexposed, sick), 2014 De Jonge, 2013 Jimenez-Solem (Controls unexposed, sick), 2012 Colvin, 2011 Malm, 2011 70.25.01.0

Publication bias and p-hacking diagnosis

funnel plot
0.0-3.33.31.7020.000Anderson, 2020Bérard, 2017Ban (Controls unexposed, sick), 2014De Jonge, 2013Jimenez-Solem (Controls unexposed, sick), 2012Colvin, 2011Malm, 2011

Asymetry test p-value = 0.3539 (by Egger's regression)

slope=0.1531 (0.1812); intercept=-0.5963 (0.5838); t=1.0214; p=0.3539

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) 1.00[0.71; 1.41]14,7603,4890%NAAnderson, 2020 Ban (Controls unexposed, disease free), 2014 De Jonge, 2013 Jimenez-Solem (Controls unexposed, NOS), 2012 Colvin, 2011 Malm, 2011 6 unexposed, sick controlsunexposed, sick controls 0.97[0.74; 1.27]832,9000%NABérard, 2017 Ban (Controls unexposed, sick), 2014 Jimenez-Solem (Controls unexposed, sick), 2012 30.510.01.0