Fluoxetine updated on 07-01-2025

Digestive 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.
S7438
R21943		 Bérard, 2017 Digestive 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) 0.87 [0.21;3.56] -/191   -/14,847 - 191
ref
S7349
R21476		 Wemakor, 2015 Digestive system anomalies 1st trimester case control unexposed (general population or NOS) Adjustment: Yes Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...) 0.96 [0.36;2.51] 5/32   2,734/19,790 2,739 32
ref
S5882
R14698		 Ban (Controls unexposed, disease free), 2014 Digestive system malformations 1st trimester retrospective cohort (claims database) unexposed, disease free Adjustment: Yes Monotherapy: substance alone among the specific class of antidep (SSRI, SNRI, ...) 1.26 [0.47;3.39] -/3,189   313/325,294 - 3,189
ref
S6016
R15532		 Jimenez-Solem (Controls unexposed, NOS), 2012 Congenital malformations of the digestive system 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, ...) 1.25 [0.31;5.00]
excluded (control group) 		2/928   1,545/843,797 1,547 928
ref
S6021
R15614		 Jimenez-Solem (Controls unexposed, sick), 2012 Congenital malformations of the digestive system 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) 1.74 [0.16;19.21] C 2/928   1/806 3 928
ref
S7194
R20424		 Colvin, 2011 Gastrointestinal defects (ICD 749–751) 1st trimester retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: No Monotherapy: substance alone among the specific class of antidep (SSRI, SNRI, ...) 3.08 [1.27;7.48] 5/291   534/94,561 539 291
ref
S6242
R16498		 Malm, 2011 Digestive system 1st trimester population based cohort retrospective unexposed (general population or NOS) Adjustment: Yes Monotherapy: no or not specified 0.90 [0.37;2.17] -/1,818   -/628,607 - 1,818
ref
Total 6 studies 1.33 [0.86;2.06] 3,281 6,449
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 0.87[0.21; 3.56]-1919%ROB confusion: seriousROB selection: moderateROB classification: criticalROB missing: lowROB mesure: moderateROB reporting: moderate Wemakor, 2015Wemakor, 2015 0.96[0.36; 2.51]2,7393220%ROB confusion: criticalROB selection: criticalROB classification: moderateROB missing: lowROB mesure: moderateROB reporting: moderate Ban (Controls unexposed, disease free), 2014Ban, 2014 1 1.26[0.47; 3.39]-3,18919%ROB confusion: seriousROB selection: moderateROB classification: criticalROB missing: lowROB mesure: criticalROB reporting: moderate Jimenez-Solem (Controls unexposed, sick), 2012Jimenez-Solem, 2012 2 1.74[0.16; 19.21]39283%ROB confusion: criticalROB selection: moderateROB classification: criticalROB missing: lowROB mesure: moderateROB reporting: critical Colvin, 2011Colvin, 2011 3.08[1.27; 7.48]53929124%ROB confusion: criticalROB selection: moderateROB classification: moderateROB missing: unclearROB mesure: moderateROB reporting: moderate Malm, 2011Malm, 2011 0.90[0.37; 2.17]-1,81824%ROB confusion: criticalROB selection: lowROB classification: criticalROB missing: lowROB mesure: criticalROB reporting: moderate Total (6 studies) I2 = 1% 1.33[0.86; 2.06]3,2816,4490.210.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

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

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 1.43[0.85; 2.42]5426,41711%NABérard, 2017 Ban (Controls unexposed, disease free), 2014 Jimenez-Solem (Controls unexposed, sick), 2012 Colvin, 2011 Malm, 2011 5 case control studiescase control studies 0.96[0.36; 2.53]2,73932 -NAWemakor, 2015 1 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 1.37[0.77; 2.44]3,2785,33035%NAWemakor, 2015 Ban (Controls unexposed, disease free), 2014 Colvin, 2011 Malm, 2011 4 unexposed, sickunexposed, sick 1.04[0.31; 3.52]31,1190%NABérard, 2017 Jimenez-Solem (Controls unexposed, sick), 2012 2 Tags Adjustment   - No  - No 2.88[1.25; 6.61]5421,2190%NAJimenez-Solem (Controls unexposed, sick), 2012 Colvin, 2011 2   - Yes  - Yes 1.00[0.60; 1.66]2,7395,2300%NABérard, 2017 Wemakor, 2015 Ban (Controls unexposed, disease free), 2014 Malm, 2011 4 Monotherapy   - no or not specified  - no or not specified 0.90[0.37; 2.18]-1,818 -NAMalm, 2011 1   - substance alone among all Antidep ( ...  - substance alone among all Antidep (SSRI, SNRI, ...) 0.93[0.42; 2.07]2,7392230%NABérard, 2017 Wemakor, 2015 2   - substance alone among the specific ...  - substance alone among the specific class of antidep (SSRI, SNRI, ...) 2.04[1.08; 3.86]5424,4080%NABan (Controls unexposed, disease free), 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) 1.04[0.31; 3.52]31,1190%NABérard, 2017 Jimenez-Solem (Controls unexposed, sick), 2012 2 All studiesAll studies 1.33[0.86; 2.06]3,2816,4491%NABérard, 2017 Wemakor, 2015 Ban (Controls unexposed, disease free), 2014 Jimenez-Solem (Controls unexposed, sick), 2012 Colvin, 2011 Malm, 2011 60.210.01.0

Publication bias and p-hacking diagnosis

funnel plot
0.0-2.93.21.4710.000Bérard, 2017Wemakor, 2015Ban (Controls unexposed, disease free), 2014Jimenez-Solem (Controls unexposed, sick), 2012Colvin, 2011Malm, 2011

Asymetry test p-value = 0.8540 (by Egger's regression)

slope=0.4542 (0.8940); intercept=-0.3234 (1.6482); t=0.1962; p=0.8540

p values plot
0.01.00.01.0

Sub-groups analysis using all included studies

excluded 6016

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 1.36[0.84; 2.19]5,1296,25814%NAWemakor, 2015 Ban (Controls unexposed, disease free), 2014 Jimenez-Solem (Controls unexposed, NOS), 2012 Colvin, 2011 Malm, 2011 5 unexposed, sick controlsunexposed, sick controls 1.04[0.31; 3.52]31,1190%NABérard, 2017 Jimenez-Solem (Controls unexposed, sick), 2012 20.510.01.0

Umbrella review (other published meta-analyses)

Published MAControlPeriodTE95% CIn exposedkI2 Gao (Digestive system anomalies)Gao (Digestive system anomalies) 1.08[0.60; 1.96]0%-Wwhatever (meta-analysis)T11st trimesterstudies TTT3 metaPregmetaPreg 1.33[0.86; 2.06]1%6,449----Bérard, 2017 Wemakor, 2015 Ban (Controls unexposed, disease free), 2014 Jimenez-Solem (Controls unexposed, sick), 2012 Colvin, 2011 Malm, 2011 60.510.01.0