Mirtazapine updated on 07-01-2025

Neonatal death (< 28 days of life)

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
R78324
Lee (Controls exposed to SSRI), 2025 Neonatal death (≤28 days after birth) 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, ...) 19.26 [1.19;310.95] C
excluded (control group)
1/77   1/1,465 2 77
ref
S18417
R77893
Lee (Controls unexposed, general pop), 2025 Neonatal death (≤28 days after birth) 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, ...) 9.27 [1.21;70.86] 1/77   627/463,440 628 77
ref
S12950
R49149
Ostenfeld, 2022 Neonatal deaths (death of the infant 0–27 days after birth) during pregnancy (anytime or not specified) population based cohort retrospective unexposed (general population or NOS) Adjustment: Yes Monotherapy: no or not specified 0.60 [0.18;2.02] 3/897   20/3,588 23 897
ref
Total 2 studies 2.08 [0.14;30.02] 651 974
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 9.27[1.21; 70.86]6287745%ROB confusion: moderateROB selection: lowROB classification: moderateROB missing: lowROB mesure: moderateROB reporting: moderate Ostenfeld, 2022Ostenfeld, 2022 0.60[0.18; 2.02]2389755%ROB confusion: seriousROB selection: lowROB classification: criticalROB missing: lowROB mesure: moderateROB reporting: moderate Total (2 studies) I2 = 81% 2.08[0.14; 30.02]6519740.220.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Controls unexposed, general pop;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 2.08[0.14; 30.02]65197481%NALee (Controls unexposed, general pop), 2025 Ostenfeld, 2022 2 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 2.08[0.14; 30.02]65197481%NALee (Controls unexposed, general pop), 2025 Ostenfeld, 2022 2 Tags Adjustment   - Yes  - Yes 2.08[0.14; 30.02]65197481%NALee (Controls unexposed, general pop), 2025 Ostenfeld, 2022 2 Monotherapy   - no or not specified  - no or not specified 0.60[0.18; 2.01]23897 -NAOstenfeld, 2022 1   - substance alone among all Antidep ( ...  - substance alone among all Antidep (SSRI, SNRI, ...) 9.27[1.21; 70.94]62877 -NALee (Controls unexposed, general pop), 2025 1 All studiesAll studies 2.08[0.14; 30.02]65197481%NALee (Controls unexposed, general pop), 2025 Ostenfeld, 2022 20.220.01.0

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 18444

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 2.08[0.14; 30.02]65197481%NALee (Controls unexposed, general pop), 2025 Ostenfeld, 2022 2 exposed to other treatment, sick controlsexposed to other treatment, sick controls Out of scale19.26[1.19; 310.95]277 -NALee (Controls exposed to SSRI), 2025 10.510.01.0