Quetiapine 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.
S18398
R77624		 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 1.77 [0.96;3.26] C
excluded (control group) 		20/191   26/420 46 191
ref
S18341
R77625		 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 1.97 [0.91;4.60]
excluded (control group) 		20/191   22,929/464,017 22,949 191
ref
S18395
R77626		 Chan (Controls unexposed, sick), 2024 Major congenital malformations at least 1st trimester retrospective cohort (claims database) unexposed, sick Adjustment: Yes 1.99 [0.87;4.93] 18/169   385/6,476 403 169
ref
S14430
R57274		 Cohen, 2023 Major congenital malformations 1st trimester prospective cohort unexposed, sick Adjustment: Yes 1.05 [0.38;2.89] 5/273   16/904 21 273
ref
S14301
R56379		 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 1.01 [0.92;1.10]
excluded (control group) 		469/11,065   177,165/6,455,324 177,634 11,065
ref
S14300
R56367		 Huybrechts (Controls unexposed, sick), 2023 Major congenital malformations overall (excluding chromosomal abnormality) 1st trimester population based cohort retrospective unexposed, sick Adjustment: Yes 1.02 [0.92;1.13] 367/8,350   11,647/318,731 12,014 8,350
ref
S2482
R11425		 Raguideau, 2017 26 major malformations early pregnancy retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: No 1.90 [0.50;4.80] 4/219   18,682/1,888,130 18,686 219
ref
S3894
R11423		 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
S2442
R11419		 Habermann (Control exposed to FGA), 2013 Major malformations 1st trimester prospective cohort exposed to other treatment, sick excluded Adjustment: No 0.85 [0.28;2.58] C
excluded (control group) 		5/139   9/213 14 139
ref
S2441
R11420		 Habermann (Control unexposed, disease free), 2013 Major malformations 1st trimester prospective cohort unexposed, disease free Adjustment: No 1.48 [0.56;3.92] C 5/139   25/1,014 30 139
ref
S2702
R11424		 Peng, 2013 Major malformations throughout pregnancy prospective cohort unexposed, disease free Adjustment: No 13.73 [0.25;760.39] C 0/6   0/76 0 6
ref
S2697
R11428		 Sadowski, 2013 Major malformations during pregnancy (anytime or not specified) excluded prospective cohort unexposed, disease free Adjustment: No 2.57 [0.62;10.56] C
excluded (exposition period) 		6/94   3/116 9 94
ref
S2467
R11426		 Reis (Control exposed to FGA), 2008 Relatively severe malformations early pregnancy population based cohort retrospective exposed to other treatment, sick excluded Adjustment: No 2.75 [0.14;54.90] C
excluded (control group) 		0/4   21/435 21 4
ref
S2470
R11427		 Reis (Unexposed control, NOS), 2008 Relative severe malformations early pregnancy population based cohort retrospective unexposed (general population or NOS) Adjustment: No 4.39 [0.23;85.02] C 0/4   30,679/973,767 30,679 4
ref
S2705
R11422		 McKenna, 2005 Major malformations 1st trimester prospective cohort unexposed, disease free Adjustment: No 0.75 [0.04;15.90] C 0/36   2/135 2 36
ref
Total 8 studies 1.04 [0.94;1.15] 61,835 9,196
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 1.99[0.87; 4.93]4031691%ROB confusion: seriousROB selection: moderateROB classification: moderateROB missing: unclearROB mesure: moderateROB reporting: moderate Cohen, 2023Cohen, 2023 1.05[0.38; 2.89]212731%ROB confusion: criticalROB selection: unclearROB classification: moderateROB missing: lowROB mesure: criticalROB reporting: low Huybrechts (Controls unexposed, sick), 2023Huybrechts, 2023 2 1.02[0.92; 1.13]12,0148,35096%ROB confusion: moderateROB selection: moderateROB classification: moderateROB missing: unclearROB mesure: unclearROB reporting: moderate Raguideau, 2017Raguideau, 2017 1.90[0.50; 4.80]18,6862191%ROB confusion: criticalROB selection: lowROB classification: criticalROB missing: unclearROB mesure: moderateROB reporting: moderate Habermann (Control unexposed, disease free), 2013Habermann, 2013 3 1.48[0.56; 3.92]301391%ROB confusion: criticalROB selection: moderateROB classification: moderateROB missing: moderateROB mesure: criticalROB reporting: moderate Peng, 2013Peng, 2013 13.73[0.25; 760.39]060%ROB confusion: seriousROB selection: unclearROB classification: moderateROB missing: unclearROB mesure: moderateROB reporting: moderate Reis (Unexposed control, NOS), 2008Reis, 2008 4 4.39[0.23; 85.02]30,67940%ROB confusion: criticalROB selection: moderateROB classification: moderateROB missing: lowROB mesure: unclearROB reporting: moderate McKenna, 2005McKenna, 2005 0.75[0.04; 15.90]2360%ROB confusion: criticalROB selection: criticalROB classification: moderateROB missing: unclearROB mesure: moderateROB reporting: moderate Total (8 studies) I2 = 0% 1.04[0.94; 1.15]61,8359,1960.250.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Controls unexposed, sick; 2: Controls unexposed, sick; 3: Control unexposed, disease free; 4: Unexposed control, NOS;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 1.04[0.94; 1.15]61,8359,1960%NAChan (Controls unexposed, sick), 2024 Cohen, 2023 Huybrechts (Controls unexposed, sick), 2023 Raguideau, 2017 Habermann (Control unexposed, disease free), 2013 Peng, 2013 Reis (Unexposed control, NOS), 2008 McKenna, 2005 8 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 1.77[0.89; 3.53]49,3974040%NARaguideau, 2017 Habermann (Control unexposed, disease free), 2013 Peng, 2013 Reis (Unexposed control, NOS), 2008 McKenna, 2005 5 unexposed, sickunexposed, sick 1.07[0.84; 1.36]12,4388,79211%NAChan (Controls unexposed, sick), 2024 Cohen, 2023 Huybrechts (Controls unexposed, sick), 2023 3 Tags Adjustment   - No  - No 1.77[0.89; 3.53]49,3974040%NARaguideau, 2017 Habermann (Control unexposed, disease free), 2013 Peng, 2013 Reis (Unexposed control, NOS), 2008 McKenna, 2005 5   - Yes  - Yes 1.07[0.84; 1.36]12,4388,79211%NAChan (Controls unexposed, sick), 2024 Cohen, 2023 Huybrechts (Controls unexposed, sick), 2023 3 All studiesAll studies 1.04[0.94; 1.15]61,8359,1960%NAChan (Controls unexposed, sick), 2024 Cohen, 2023 Huybrechts (Controls unexposed, sick), 2023 Raguideau, 2017 Habermann (Control unexposed, disease free), 2013 Peng, 2013 Reis (Unexposed control, NOS), 2008 McKenna, 2005 80.250.01.0

Publication bias and p-hacking diagnosis

funnel plot
0.0-4.84.92.4580.000Chan (Controls unexposed, sick), 2024Cohen, 2023Huybrechts (Controls unexposed, sick), 2023Raguideau, 2017Habermann (Control unexposed, disease free), 2013Peng, 2013Reis (Unexposed control, NOS), 2008McKenna, 2005

Asymetry test p-value = 0.0202 (by Egger's regression)

slope=-0.0217 (0.0382); intercept=0.8270 (0.2637); t=3.1362; p=0.0202

p values plot
0.01.00.01.0

Sub-groups analysis using all included studies

excluded 2467, 2442, 14301, 18398, 18341

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 1.21[0.89; 1.63]249,98011,66012%NAChan (Controls unexposed, general pop), 2024 Huybrechts (Controls unexposed, NOS), 2023 Raguideau, 2017 Habermann (Control unexposed, disease free), 2013 Peng, 2013 Reis (Unexposed control, NOS), 2008 McKenna, 2005 7 unexposed, sick controlsunexposed, sick controls 1.07[0.84; 1.36]12,4388,79211%NAChan (Controls unexposed, sick), 2024 Cohen, 2023 Huybrechts (Controls unexposed, sick), 2023 3 exposed to other treatment, sick controlsexposed to other treatment, sick controls 1.52[0.90; 2.58]813340%NAChan (Controls exposed to FGA), 2024 Habermann (Control exposed to FGA), 2013 Reis (Control exposed to FGA), 2008 30.510.01.0