Fluoxetine updated on 07-01-2025

Neonatal medical care

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.
S18436
R78155		 Lee (Controls exposed to TCAs), 2025 Admission to neonatal intensive care unit (NICU) during pregnancy (anytime or not specified) retrospective cohort (claims database) exposed to other treatment, sick excluded Adjustment: No Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...) 0.89 [0.48;1.63] C
excluded (control group) 		22/719   21/613 43 719
ref
S18415
R77850		 Lee (Controls unexposed, general pop), 2025 Admission to neonatal intensive care unit (NICU) during pregnancy (anytime or not specified) retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: Yes Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...) 1.10 [0.71;1.71] 22/719   8,566/463,440 8,588 719
ref
S18261
R76712		 Cornet, 2024 Delayed neonatal adaptation (presence of at least one of the following: 5min Apgar score ≤5; positive pressure ventilation or intubation during delivery room resuscitation; or admission to the NICU with respiratory distress requiring invasive or non-invasive ventilation) late pregnancy retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: Yes Monotherapy: substance alone among the specific class of antidep (SSRI, SNRI, ...) 2.59 [2.03;3.31] -/982   12,078/272,517 - 982
ref
S13124
R50032		 Marks (Controls exposed to Bupropion), 2021 Neonatal intensive care unit admission during pregnancy (anytime or not specified) retrospective cohort exposed to other treatment, sick Adjustment: Yes Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...) 1.34 [0.96;1.87] 162/579   91/406 253 579
ref
S7693
R22800		 Kivistö, 2016 Neonatal intensive care during pregnancy (anytime or not specified) retrospective cohort unexposed (general population or NOS) Adjustment: Yes Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...) 2.23 [1.09;4.55] -/51   2,431/24,402 - 51
ref
S8044
R24475		 Oberlander, 2004 Poor neonatal adaptation (high level of medical care and observation) during pregnancy (anytime or not specified) prospective cohort unexposed, disease free Adjustment: No Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...) 7.88 [0.98;63.31] C 3/7   2/23 5 7
ref
S7765
R22972		 Suri (Controls unexposed, disease free), 2004 Neonatal Intensive Care Unit (NICU) admissions during pregnancy (anytime or not specified) prospective cohort unexposed, disease free excluded Adjustment: No Monotherapy: SSRI only 0.52 [0.09;2.95] C
excluded (control group) 		3/28   3/16 6 28
ref
S7766
R22973		 Suri (Controls unexposed, sick), 2004 Neonatal Intensive Care Unit (NICU) admissions during pregnancy (anytime or not specified) prospective cohort unexposed, sick Adjustment: No Monotherapy: SSRI only Unexposed sick: old history of illness/treatment (> 12 months before pregnancy) or not specified 0.96 [0.14;6.39] C 3/28   2/18 5 28
ref
S15005
R61436		 Chambers, 1996 Admission to a special-care nursery late pregnancy prospective cohort unexposed (general population or NOS) Adjustment: No Monotherapy: no or not specified 4.74 [2.41;9.30] C 23/73   20/226 43 73
ref
Total 7 studies 2.05 [1.32;3.17] 8,894 2,439
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 Lee (Controls unexposed, general pop), 2025Lee, 2025 1 1.10[0.71; 1.71]8,58871919%ROB confusion: moderateROB selection: lowROB classification: criticalROB missing: lowROB mesure: moderateROB reporting: moderate Cornet, 2024Cornet, 2024 2.59[2.03; 3.31]-98222%ROB confusion: moderateROB selection: lowROB classification: moderateROB missing: unclearROB mesure: moderateROB reporting: moderate Marks (Controls exposed to Bupropion), 2021Marks, 2021 2 1.34[0.96; 1.87]25357921%ROB confusion: criticalROB selection: lowROB classification: moderateROB missing: unclearROB mesure: moderateROB reporting: moderate Kivistö, 2016Kivistö, 2016 2.23[1.09; 4.55]-5115%ROB confusion: seriousROB selection: criticalROB classification: moderateROB missing: criticalROB mesure: moderateROB reporting: moderate Oberlander, 2004Oberlander, 2004 7.88[0.98; 63.31]574%ROB confusion: criticalROB selection: criticalROB classification: lowROB missing: lowROB mesure: moderateROB reporting: NA Suri (Controls unexposed, sick), 2004Suri, 2004 3 0.96[0.14; 6.39]5284%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Chambers, 1996Chambers, 1996 4.74[2.41; 9.30]437315%ROB confusion: criticalROB selection: criticalROB classification: lowROB missing: lowROB mesure: moderateROB reporting: moderate Total (7 studies) I2 = 77% 2.05[1.32; 3.17]8,8942,4390.220.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Controls unexposed, general pop; 2: Controls exposed to Bupropion; 3: Controls unexposed, sick;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 2.05[1.32; 3.17]8,8942,43977%NALee (Controls unexposed, general pop), 2025 Cornet, 2024 Marks (Controls exposed to Bupropion), 2021 Kivistö, 2016 Oberlander, 2004 Suri (Controls unexposed, sick), 2004 Chambers, 1996 7 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 2.43[1.42; 4.17]8,6361,83277%NALee (Controls unexposed, general pop), 2025 Cornet, 2024 Kivistö, 2016 Oberlander, 2004 Chambers, 1996 5 unexposed, sickunexposed, sick 0.96[0.14; 6.39]528 -NASuri (Controls unexposed, sick), 2004 1 exposed to other treatment, sickexposed to other treatment, sick 1.34[0.96; 1.87]253579 -NAMarks (Controls exposed to Bupropion), 2021 1 Tags Adjustment   - No  - No 3.78[1.48; 9.64]5310829%NAOberlander, 2004 Suri (Controls unexposed, sick), 2004 Chambers, 1996 3   - Yes  - Yes 1.70[1.08; 2.68]8,8412,33182%NALee (Controls unexposed, general pop), 2025 Cornet, 2024 Marks (Controls exposed to Bupropion), 2021 Kivistö, 2016 4 Monotherapy   - no or not specified  - no or not specified 4.74[2.41; 9.30]4373 -NAChambers, 1996 1   - SSRI only  - SSRI only 0.96[0.14; 6.39]528 -NASuri (Controls unexposed, sick), 2004 1   - substance alone among all Antidep ( ...  - substance alone among all Antidep (SSRI, SNRI, ...) 1.47[0.99; 2.18]8,8461,35645%NALee (Controls unexposed, general pop), 2025 Marks (Controls exposed to Bupropion), 2021 Kivistö, 2016 Oberlander, 2004 4   - substance alone among the specific ...  - substance alone among the specific class of antidep (SSRI, SNRI, ...) 2.59[2.03; 3.31]-982 -NACornet, 2024 1 Unexposed sick   - old history of illness/treatment (> ...  - old history of illness/treatment (> 12 months before pregnancy) or not specified 0.96[0.14; 6.39]528 -NASuri (Controls unexposed, sick), 2004 1 All studiesAll studies 2.05[1.32; 3.17]8,8942,43977%NALee (Controls unexposed, general pop), 2025 Cornet, 2024 Marks (Controls exposed to Bupropion), 2021 Kivistö, 2016 Oberlander, 2004 Suri (Controls unexposed, sick), 2004 Chambers, 1996 70.220.01.0

Publication bias and p-hacking diagnosis

funnel plot
0.0-2.53.21.2760.000Lee (Controls unexposed, general pop), 2025Cornet, 2024Marks (Controls exposed to Bupropion), 2021Kivistö, 2016Oberlander, 2004Suri (Controls unexposed, sick), 2004Chambers, 1996

Asymetry test p-value = 0.8838 (by Egger's regression)

slope=0.6430 (0.3556); intercept=0.2416 (1.5712); t=0.1538; p=0.8838

p values plot
0.01.00.01.0

Sub-groups analysis using all included studies

excluded 7765, 18436

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 2.19[1.28; 3.75]23,1331,86075%NALee (Controls unexposed, general pop), 2025 Cornet, 2024 Kivistö, 2016 Oberlander, 2004 Suri (Controls unexposed, disease free), 2004 Chambers, 1996 6 unexposed, sick controlsunexposed, sick controls 0.96[0.14; 6.39]528 -NASuri (Controls unexposed, sick), 2004 1 exposed to other treatment, sick controlsexposed to other treatment, sick controls 1.19[0.82; 1.71]2961,29825%NALee (Controls exposed to TCAs), 2025 Marks (Controls exposed to Bupropion), 2021 20.510.01.0