Fluoxetine updated on 07-01-2025

Cognitive developmental disorders/delay (3-6 years old)

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.
S18251
R76877
Suarez (Controls unexposed, discontinuers), 2022 Intellectual disability - ≥ 2 dates with ICD-9 Dx 317, 318.x, 319 - At ≥ 2 years of age 2nd and/or 3rd trimester retrospective cohort (claims database) unexposed, sick Adjustment: Yes Monotherapy: no or not specified Unexposed sick: recent illness/treatment (during or juste before pregnancy or treatment stopped in view of pregnancy) 0.73 [0.30;1.76] 47/18,357   13/5,638 60 18,357
ref
S18252
R76878
Suarez (Controls unexposed, general pop), 2022 Intellectual disability - ≥ 2 dates with ICD-9 Dx 317, 318.x, 319 - At ≥ 2 years of age 2nd and/or 3rd trimester retrospective cohort (claims database) unexposed (general population or NOS) excluded Adjustment: Yes Monotherapy: no or not specified 0.96 [0.68;1.36]
excluded (control group)
47/18,385   2,800/1,790,067 2,847 18,385
ref
S10004
R53804
Ames, 2021 Developmental delays or disorders (identified from clinical or educational settings) and with score <11 on the SCQ or score >=11 but did not meet study criteria for ASD after the in-person assessment (presence or absence of co-occurring ID defined by MSEL composite standard scores <=70) (Age NOS). 3 months (or more) before pregnancy or during pregnancy excluded case control unexposed, disease free Adjustment: No Monotherapy: no or not specified 1.65 [0.96;2.84] C
excluded (exposition period)
36/57   1,714/3,364 1,750 57
ref
S8015
R53805
Nulman (Controls exposed to TCA), 2002 Global IQ with the McCarthy Scales of Children’s Abilities at 30 and 71 months of age throughout pregnancy prospective cohort exposed to other treatment, sick excluded Adjustment: No extrapolated (cont. endpoint) Monotherapy: SSRI only 3.35 [0.60;18.67]
excluded (control group)
-/6   -/18 - 6
ref
S8016
R53806
Nulman (Controls unexposed, disease free), 2002 Global IQ with the McCarthy Scales of Children’s Abilities at 30 and 71 months of age throughout pregnancy prospective cohort unexposed, disease free Adjustment: No extrapolated (cont. endpoint) Monotherapy: SSRI only 3.79 [0.66;21.98] -/6   -/16 - 6
ref
Total 2 studies 1.39 [0.29;6.70] 60 18,363
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 Suarez (Controls unexposed, discontinuers), 2022Suarez, 2022 1 0.73[0.30; 1.76]6018,35761%ROB confusion: seriousROB selection: lowROB classification: moderateROB missing: lowROB mesure: criticalROB reporting: moderate Nulman (Controls unexposed, disease free), 2002Nulman, 2002 2 3.79[0.66; 21.98]-639%ROB confusion: seriousROB selection: moderateROB classification: moderateROB missing: lowROB mesure: lowROB reporting: moderate Total (2 studies) I2 = 63% 1.39[0.29; 6.70]6018,3630.210.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

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

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 1.39[0.29; 6.70]6018,36363%NASuarez (Controls unexposed, discontinuers), 2022 Nulman (Controls unexposed, disease free), 2002 2 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 3.79[0.66; 21.87]-6 -NANulman (Controls unexposed, disease free), 2002 1 unexposed, sickunexposed, sick 0.73[0.30; 1.77]6018,357 -NASuarez (Controls unexposed, discontinuers), 2022 1 Tags Adjustment   - No  - No 3.79[0.66; 21.87]-6 -NANulman (Controls unexposed, disease free), 2002 1   - Yes  - Yes 0.73[0.30; 1.77]6018,357 -NASuarez (Controls unexposed, discontinuers), 2022 1 extrapolated (cont. endpoint)extrapolated (cont. endpoint) 3.79[0.66; 21.87]-6 -NANulman (Controls unexposed, disease free), 2002 1 Monotherapy   - no or not specified  - no or not specified 0.73[0.30; 1.77]6018,357 -NASuarez (Controls unexposed, discontinuers), 2022 1   - SSRI only  - SSRI only 3.79[0.66; 21.87]-6 -NANulman (Controls unexposed, disease free), 2002 1 Unexposed sick   - recent illness/treatment (during o ...  - recent illness/treatment (during or juste before pregnancy or treatment stopped in view of pregnancy) 0.73[0.30; 1.77]6018,357 -NASuarez (Controls unexposed, discontinuers), 2022 1 All studiesAll studies 1.39[0.29; 6.70]6018,36363%NASuarez (Controls unexposed, discontinuers), 2022 Nulman (Controls unexposed, disease free), 2002 20.210.01.0

Publication bias and p-hacking diagnosis

funnel plot

Funnel plot not drawn. Less than 3 points.

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

not enought points

p values plot

Funnel plot not drawn. Less than 3 points.

Sub-groups analysis using all included studies

excluded 8015, 18252

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 1.44[0.42; 4.93]2,84718,39156%NASuarez (Controls unexposed, general pop), 2022 Nulman (Controls unexposed, disease free), 2002 2 unexposed, sick controlsunexposed, sick controls 0.73[0.30; 1.77]6018,357 -NASuarez (Controls unexposed, discontinuers), 2022 1 exposed to other treatment, sick controlsexposed to other treatment, sick controls 3.35[0.60; 18.69]-6 -NANulman (Controls exposed to TCA), 2002 10.510.01.0