Mirtazapine updated on 07-01-2025

Low birth weight (< 2500g)

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.
S18444
R78317		 Lee (Controls exposed to SSRI), 2025 Low birth weight (birth weight <2500 g) 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, ...) 1.66 [0.87;3.14] C
excluded (control group) 		12/77   147/1,465 159 77
ref
S18417
R77886		 Lee (Controls unexposed, general pop), 2025 Low birth weight (birth weight <2500 g) 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, ...) 1.92 [1.04;3.57] 12/77   31,347/463,440 31,359 77
ref
S12919
R49006		 Gungor (Controls exposed to SSRI), 2019 Low Birth Weight (birth weight lower than 2500 g) during pregnancy (anytime or not specified) prospective cohort exposed to other treatment, sick excluded Adjustment: No Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...) 0.60 [0.06;5.82] C
excluded (control group) 		1/16   4/40 5 16
ref
S12920
R49012		 Gungor (Controls unexposed, disease free), 2019 Low Birth Weight (birth weight lower than 2500 g) during pregnancy (anytime or not specified) prospective cohort unexposed, disease free excluded Adjustment: No Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...) 0.70 [0.06;8.45] C
excluded (control group) 		1/16   2/23 3 16
ref
S12921
R49018		 Gungor (Controls unexposed, sick), 2019 Low Birth Weight (birth weight lower than 2500 g) during pregnancy (anytime or not specified) prospective cohort unexposed, sick Adjustment: No Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...) Unexposed sick: old history of illness/treatment (> 12 months before pregnancy) or not specified 0.44 [0.04;4.71] C 1/16   3/23 4 16
ref
Total 2 studies 1.47 [0.48;4.46] 31,363 93
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 1.92[1.04; 3.57]31,3597782%ROB confusion: seriousROB selection: lowROB classification: moderateROB missing: lowROB mesure: moderateROB reporting: moderate Gungor (Controls unexposed, sick), 2019Gungor, 2019 2 0.44[0.04; 4.71]41618%ROB confusion: seriousROB selection: unclearROB classification: moderateROB missing: unclearROB mesure: moderateROB reporting: moderate Total (2 studies) I2 = 28% 1.47[0.48; 4.46]31,363930.25.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Controls unexposed, general pop; 2: Controls unexposed, sick;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 1.47[0.48; 4.46]31,3639328%NALee (Controls unexposed, general pop), 2025 Gungor (Controls unexposed, sick), 2019 2 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 1.92[1.04; 3.56]31,35977 -NALee (Controls unexposed, general pop), 2025 1 unexposed, sickunexposed, sick 0.44[0.04; 4.71]416 -NAGungor (Controls unexposed, sick), 2019 1 Tags Adjustment   - No  - No 0.44[0.04; 4.71]416 -NAGungor (Controls unexposed, sick), 2019 1   - Yes  - Yes 1.92[1.04; 3.56]31,35977 -NALee (Controls unexposed, general pop), 2025 1 Monotherapy   - substance alone among all Antidep ( ...  - substance alone among all Antidep (SSRI, SNRI, ...) 1.47[0.48; 4.46]31,3639328%NALee (Controls unexposed, general pop), 2025 Gungor (Controls unexposed, sick), 2019 2 Unexposed sick   - old history of illness/treatment (> ...  - old history of illness/treatment (> 12 months before pregnancy) or not specified 0.44[0.04; 4.71]416 -NAGungor (Controls unexposed, sick), 2019 1 All studiesAll studies 1.47[0.48; 4.46]31,3639328%NALee (Controls unexposed, general pop), 2025 Gungor (Controls unexposed, sick), 2019 20.25.01.0

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 12919, 12920, 18444

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 1.81[1.00; 3.30]31,362930%NALee (Controls unexposed, general pop), 2025 Gungor (Controls unexposed, disease free), 2019 2 unexposed, sick controlsunexposed, sick controls Out of scale0.44[0.04; 4.71]416 -NAGungor (Controls unexposed, sick), 2019 1 exposed to other treatment, sick controlsexposed to other treatment, sick controls 1.54[0.83; 2.84]164930%NALee (Controls exposed to SSRI), 2025 Gungor (Controls exposed to SSRI), 2019 20.510.01.0

Umbrella review (other published meta-analyses)

Published MAControlPeriodTE95% CIn exposedkI2 Vlenterie (Low birth weigh (< 2500 grams))Vlenterie (Low birth weigh (< 2500 grams)) Out of scale0.50[0.20; 1.40]-U,Sunexposed, sickAnyduring pregnancy (anytime or not specified)studies TTT1 Vlenterie (Low birth weigh (< 2500 grams))Vlenterie (Low birth weigh (< 2500 grams)) Out of scale0.50[0.20; 1.40]-U,GPunexposed (general population or NOS)Anyduring pregnancy (anytime or not specified)studies TTT1 metaPregmetaPreg 1.47[0.48; 4.46]28%93----Lee (Controls unexposed, general pop), 2025 Gungor (Controls unexposed, sick), 2019 20.510.01.0