Olanzapine updated on 06-10-2025

All congenital malformations (majors, minors, majors and minors, or unspecified)

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.
S18397
R77621
Chan (Controls exposed to FGA), 2024 Major congenital malformations at least 1st trimester retrospective cohort (claims database) exposed to other treatment, sick excluded Adjustment: No 1.19 [0.52;2.70] C
excluded (control group)
8/110   26/420 34 110
ref
S18340
R77622
Chan (Controls unexposed, general pop), 2024 Major congenital malformations at least 1st trimester retrospective cohort (claims database) unexposed (general population or NOS) excluded Adjustment: Yes 0.65 [0.22;1.73]
excluded (control group)
8/110   22,929/464,017 22,937 110
ref
S18394
R77623
Chan (Controls unexposed, sick), 2024 Major congenital malformations at least 1st trimester retrospective cohort (claims database) unexposed, sick Adjustment: Yes 1.71 [0.44;8.36] 7/101   385/6,476 392 101
ref
S14305
R56427
Huybrechts (Controls unexposed, NOS), 2023 Major congenital malformations overall (excluding chromosomal abnormality) 1st trimester population based cohort retrospective unexposed (general population or NOS) excluded Adjustment: Yes 1.20 [1.01;1.42]
excluded (control group)
137/3,110   177,165/6,455,324 177,302 3,110
ref
S14304
R56415
Huybrechts (Controls unexposed, sick), 2023 Major congenital malformations overall (excluding chromosomal abnormality) 1st trimester population based cohort retrospective unexposed, sick Adjustment: Yes 1.18 [0.97;1.42] 106/2,341   11,647/318,731 11,753 2,341
ref
S14432
R77643
Viguera, 2023 Major congenital malformations 1st trimester prospective cohort unexposed, sick Adjustment: No 0.60 [0.04;10.10] C 0/49   19/1,156 19 49
ref
S2480
R11434
Raguideau, 2017 26 major malformations early pregnancy retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: Yes 1.10 [0.60;2.20] 9/770   18,682/1,888,130 18,691 770
ref
S3896
R11432
Ozturk, 2016 Major birth defects during pregnancy (anytime or not specified) excluded retrospective cohort unexposed (general population or NOS) Adjustment: No 7.70 [0.34;172.00] C
excluded (exposition period)
0/5   3/246 3 5
ref
S2477
R11430
Källen, 2013 Relatively severe malformations early pregnancy population based cohort retrospective unexposed (general population or NOS) Adjustment: No 0.93 [0.40;1.84] 6/205   -/- - 205
ref
S2701
R11433
Peng, 2013 Major malformations throughout pregnancy prospective cohort unexposed, disease free Adjustment: No 10.07 [0.19;544.79] C 0/8   0/76 0 8
ref
S2696
R11437
Sadowski, 2013 Major malformations during pregnancy (anytime or not specified) excluded prospective cohort unexposed, disease free Adjustment: No 1.71 [0.17;17.23] C
excluded (exposition period)
1/23   3/116 4 23
ref
S2703
R11431
McKenna, 2005 Major malformations 1st trimester prospective cohort unexposed, disease free Adjustment: No 1.13 [0.10;12.68] C 1/60   2/135 3 60
ref
Total 7 studies 1.17 [0.98;1.39] 30,858 3,534
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 Chan (Controls unexposed, sick), 2024Chan, 2024 1 1.71[0.44; 8.36]3921011%ROB confusion: seriousROB selection: moderateROB classification: moderateROB missing: unclearROB mesure: moderateROB reporting: moderate Huybrechts (Controls unexposed, sick), 2023Huybrechts, 2023 2 1.18[0.97; 1.42]11,7532,34185%ROB confusion: moderateROB selection: moderateROB classification: moderateROB missing: unclearROB mesure: unclearROB reporting: moderate Viguera, 2023Viguera, 2023 0.60[0.04; 10.10]19490%ROB confusion: criticalROB selection: unclearROB classification: moderateROB missing: lowROB mesure: criticalROB reporting: low Raguideau, 2017Raguideau, 2017 1.10[0.60; 2.20]18,6917707%ROB confusion: criticalROB selection: lowROB classification: criticalROB missing: unclearROB mesure: moderateROB reporting: moderate Källen, 2013Källen, 2013 0.93[0.40; 1.84]-2055%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Peng, 2013Peng, 2013 10.07[0.19; 544.79]080%ROB confusion: seriousROB selection: unclearROB classification: moderateROB missing: unclearROB mesure: moderateROB reporting: moderate McKenna, 2005McKenna, 2005 1.13[0.10; 12.68]3601%ROB confusion: criticalROB selection: criticalROB classification: moderateROB missing: unclearROB mesure: moderateROB reporting: moderate Total (7 studies) I2 = 0% 1.17[0.98; 1.39]30,8583,5340.250.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

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

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 1.17[0.98; 1.39]30,8583,5340%NAChan (Controls unexposed, sick), 2024 Huybrechts (Controls unexposed, sick), 2023 Viguera, 2023 Raguideau, 2017 Källen, 2013 Peng, 2013 McKenna, 2005 7 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 1.06[0.66; 1.72]18,6941,0430%NARaguideau, 2017 Källen, 2013 Peng, 2013 McKenna, 2005 4 unexposed, sickunexposed, sick 1.18[0.98; 1.43]12,1642,4910%NAChan (Controls unexposed, sick), 2024 Huybrechts (Controls unexposed, sick), 2023 Viguera, 2023 3 Tags Adjustment   - No  - No 0.99[0.49; 1.98]223220%NAViguera, 2023 Källen, 2013 Peng, 2013 McKenna, 2005 4   - Yes  - Yes 1.18[0.98; 1.42]30,8363,2120%NAChan (Controls unexposed, sick), 2024 Huybrechts (Controls unexposed, sick), 2023 Raguideau, 2017 3 All studiesAll studies 1.17[0.98; 1.39]30,8583,5340%NAChan (Controls unexposed, sick), 2024 Huybrechts (Controls unexposed, sick), 2023 Viguera, 2023 Raguideau, 2017 Källen, 2013 Peng, 2013 McKenna, 2005 70.250.01.0

Publication bias and p-hacking diagnosis

funnel plot
0.0-4.84.92.4440.000Chan (Controls unexposed, sick), 2024Huybrechts (Controls unexposed, sick), 2023Viguera, 2023Raguideau, 2017Källen, 2013Peng, 2013McKenna, 2005

Asymetry test p-value = 0.7438 (by Egger's regression)

slope=0.1379 (0.0732); intercept=0.1068 (0.3090); t=0.3454; p=0.7438

p values plot
0.01.00.01.0

Sub-groups analysis using all included studies

excluded 14305, 18397, 18340

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 1.17[1.00; 1.37]218,9334,2630%NAChan (Controls unexposed, general pop), 2024 Huybrechts (Controls unexposed, NOS), 2023 Raguideau, 2017 Källen, 2013 Peng, 2013 McKenna, 2005 6 unexposed, sick controlsunexposed, sick controls 1.18[0.98; 1.43]12,1642,4910%NAChan (Controls unexposed, sick), 2024 Huybrechts (Controls unexposed, sick), 2023 Viguera, 2023 3 exposed to other treatment, sick controlsexposed to other treatment, sick controls 1.19[0.52; 2.70]34110 -NAChan (Controls exposed to FGA), 2024 10.510.01.0