Atypical antipsychotics (Second generation)

Table   Graphic  
individual studies
OutcomeTE95% CIn casesn exposedkPub. bias Congenital malformations All congenital malformations (majors, minors, majors and minors, or unspecified) McKenna, 2005 Reis (Control unexposed, NOS), 2008 Vial (Control unexposed, NOS), 2009 Peng, 2013 Habermann (Control unexposed, disease free), 2013 Bellet - Aripiprazole, 2015 Vigod, 2015 Petersen (Control unexposed, disease free), 2016 Raguideau, 2017 Yakuwa, 2019 Anderson, 2020 Cohen, 2022 Huybrechts (Controls unexposed, sick), 2023 Chan (Controls unexposed, sick), 2024 141.46[1.18; 1.81]89,05122,922critical Major congenital malformations McKenna, 2005 Reis (Control unexposed, NOS), 2008 Vial (Control unexposed, NOS), 2009 Peng, 2013 Habermann (Control unexposed, disease free), 2013 Bellet - Aripiprazole, 2015 Petersen (Control unexposed, disease free), 2016 Raguideau, 2017 Yakuwa, 2019 Anderson, 2020 Cohen, 2022 Huybrechts (Controls unexposed, sick), 2023 Chan (Controls unexposed, sick), 2024 131.47[1.17; 1.86]88,96922,029critical Congenital heart defects Habermann (Control unexposed, disease free), 2013 Anderson, 2020 Huybrechts (Controls unexposed, sick), 2023 Chan (Controls unexposed, sick), 2024 41.50[0.94; 2.40]11,98517,891not evaluable Limb defects Habermann (Control unexposed, disease free), 2013 Ellfolk (Controls unexposed, NOS), 2021 Chan (Controls unexposed, sick), 2024 31.08[0.69; 1.69]3694,271not evaluable Nervous system anomalies Habermann (Control unexposed, disease free), 2013 Ellfolk (Controls unexposed, NOS), 2021 Chan (Controls unexposed, sick), 2024 31.24[0.23; 6.68]1084,271not evaluable Respiratory system anomalies Ellfolk (Controls unexposed, NOS), 2021 Chan (Controls unexposed, sick), 2024 20.27[0.03; 2.09]463,841not evaluable Urinary malformations Habermann (Control unexposed, disease free), 2013 Chan (Controls unexposed, sick), 2024 21.11[0.30; 4.18]75793not evaluable Ano-rectal atresia and stenosis Raguideau, 2017 Anderson, 2020 Huybrechts (Controls unexposed, sick), 2023 31.25[0.65; 2.39]1,60519,369not evaluable Digestive system anomalies Habermann (Control unexposed, disease free), 2013 Ellfolk (Controls unexposed, NOS), 2021 20.55[0.19; 1.58]593,908not evaluable Gastroschisis Raguideau, 2017 Anderson, 2020 Huybrechts (Controls unexposed, sick), 2023 31.58[0.90; 2.74]1,64819,369not evaluable Oesophageal atresia with or without tracheo-oesophageal fistula Raguideau, 2017 Huybrechts (Controls unexposed, sick), 2023 20.49[0.14; 1.71]41819,354not evaluable Oro-facial clefts Anderson, 2020 Huybrechts (Controls unexposed, sick), 2023 21.25[0.90; 1.75]4,58117,087not evaluable Atrial septal defect Raguideau, 2017 Anderson, 2020 22.03[1.18; 3.52]6,5102,302not evaluable Cleft lip with or without cleft palate Raguideau, 2017 Anderson, 2020 21.17[0.51; 2.67]4,7162,301not evaluable Cleft palate Raguideau, 2017 Anderson, 2020 21.96[0.82; 4.70]2,7662,302not evaluable Congenital skin disorders Habermann (Control unexposed, disease free), 2013 12.36[0.05; 119.12]-430not evaluable Craniosynostosis Raguideau, 2017 Anderson, 2020 21.54[0.53; 4.50]2,3492,301not evaluable Ear, face and neck anomalies Habermann (Control unexposed, disease free), 2013 14.73[0.43; 52.34]3430not evaluable Genetic syndromes and microdeletions Ellfolk (Controls unexposed, NOS), 2021 10.91[0.57; 1.45]1633,478not evaluable Genital anomalies Habermann (Control unexposed, disease free), 2013 10.79[0.03; 19.33]1430not evaluable Hip dislocation and/or dysplasia Huybrechts (Controls unexposed, sick), 2023 10.71[0.41; 1.22]-17,068not evaluable Hydrocephaly Huybrechts (Controls unexposed, sick), 2023 11.01[0.57; 1.77]-17,068not evaluable Hypospadias Raguideau, 2017 Anderson, 2020 21.07[0.51; 2.23]5,9222,298not evaluable Limb reduction defects (LRD) Huybrechts (Controls unexposed, sick), 2023 11.16[0.48; 2.79]-17,068not evaluable Microcephaly / Small head circumference for gestational age Boden - Olanzapine and/or clozapine, 2012 Raguideau, 2017 20.82[0.30; 2.24]4752,472not evaluable Minor congenital malformations Habermann (Control unexposed, disease free), 2013 11.20[0.66; 2.18]49453not evaluable Neural Tube Defects Huybrechts (Controls unexposed, sick), 2023 10.65[0.21; 2.02]-17,068not evaluable Bilateral renal agenesis including Potter syndrome Raguideau, 2017 15.47[0.34; 88.30]752,286not evaluable Bladder exstrophy and/or epispadia Raguideau, 2017 15.01[0.31; 80.75]822,286not evaluable Cardiac septal defects Anderson, 2020 10.80[0.27; 2.36]-16not evaluable Club foot / Talipes equinovarus Raguideau, 2017 13.91[1.95; 7.84]1,7022,286not evaluable Coarctation of aorta Raguideau, 2017 10.50[0.03; 8.01]8252,286not evaluable Diaphragmatic hernia Raguideau, 2017 12.10[0.29; 14.93]3952,286not evaluable Ebstein's anomaly Raguideau, 2017 17.87[0.49; 127.50]522,286not evaluable Hypoplastic left heart (HLH/HLHS) Raguideau, 2017 11.74[0.11; 27.89]2372,286not evaluable Hypoplastic right heart (HRH/HRHS) Raguideau, 2017 15.70[0.35; 91.99]722,286not evaluable Multicystic renal dysplasia Raguideau, 2017 10.60[0.04; 9.53]6932,286not evaluable Omphalocele Raguideau, 2017 11.46[0.09; 23.36]2832,286not evaluable Polydactyly Raguideau, 2017 12.13[0.30; 15.16]3892,286not evaluable Pulmonary artery atresia Raguideau, 2017 12.57[0.16; 41.33]1602,286not evaluable Spina bifida Raguideau, 2017 12.65[0.66; 10.62]6262,286not evaluable Tetralogy of Fallot Raguideau, 2017 10.64[0.04; 10.26]6442,286not evaluable Transposition of the great vessels Raguideau, 2017 10.75[0.05; 12.06]5482,286not evaluable Ventricular septal defect Raguideau, 2017 11.15[0.55; 2.43]5,0162,286not evaluable Growth parameters and prematurity Preterm (< 37 weeks) McKenna, 2005 Newport, 2007 Vial (Control unexposed, NOS), 2009 Lin (Control unexposed, sick), 2010 Hironaka (Control unexposed, sick), 2011 Källen, 2013 Habermann (Control unexposed, disease free), 2013 Sadowski, 2013 Bellet - Aripiprazole, 2015 Vigod, 2015 Ozturk, 2016 Schaffer (Controls unexposed, sick), 2019 Ellfolk (Control unexposed), 2019 Wang a (Controls unexposed, NOS), 2021 Viguera b, 2023 Kananen - Quetiapine, 2023 Kernizan (Controls unexposed, sick), 2024 171.24[1.06; 1.45]38,0097,938low Small for gestational age (weight) Newham (Control unexposed, disease free), 2008 Lin (Control unexposed, sick), 2010 Sadowski, 2013 Bellet - Aripiprazole, 2015 Vigod, 2015 Ellfolk (Control unexposed), 2019 Schaffer (Controls unexposed, sick), 2019 Wang a (Controls unexposed, NOS), 2021 Heinonen a (Controls unexposed, sick), 2022 Kananen - Quetiapine, 2023 101.09[0.91; 1.32]10,8998,878low Large for gestational age (weight) Newham (Control unexposed, disease free), 2008 Lin (Control unexposed, sick), 2010 Sadowski, 2013 Vigod, 2015 Ellfolk (Control unexposed), 2019 Schaffer (Controls unexposed, sick), 2019 Heinonen a (Controls unexposed, sick), 2022 Kananen - Quetiapine, 2023 81.29[1.05; 1.59]3,5578,616not evaluable Low birth weight (< 2500g) McKenna, 2005 Newport, 2007 Lin (Control unexposed, sick), 2010 Hironaka (Control unexposed, sick), 2011 Peng, 2013 52.78[1.44; 5.35]79284not evaluable Very preterm (28 to 32 weeks) Vigod, 2015 Ellfolk (Control unexposed), 2019 20.82[0.57; 1.17]3035,246not evaluable Extremely preterm (< 28 weeks) Vigod, 2015 10.48[0.25; 0.93]541,021not evaluable Large for gestational age (length) Boden - Olanzapine and/or clozapine, 2012 11.94[0.87; 4.33]-186not evaluable Large head circumference for gestational age Boden - Olanzapine and/or clozapine, 2012 13.02[1.60; 5.71]2186not evaluable Macrosomia (> 4000g) Newport, 2007 10.30[0.02; 5.17]241not evaluable Small for gestational age (length) Boden - Olanzapine and/or clozapine, 2012 11.17[0.54; 2.54]-186not evaluable Maternal consequences Caesarean Hironaka (Control unexposed, sick), 2011 Sadowski, 2013 Peng, 2013 Vigod, 2015 Ellfolk (Control unexposed), 2019 Schaffer (Controls unexposed, sick), 2019 Kernizan (Controls unexposed, sick), 2024 71.21[1.04; 1.41]5,9446,812not evaluable Gestational diabetes Hironaka (Control unexposed, sick), 2011 Vigod, 2015 Bellet - Aripiprazole, 2015 Petersen (Control discontinued treatment before pregnancy), 2016 Panchaud, 2017 Park, 2018 Schaffer (Controls unexposed, sick), 2019 Wang b - UK cohort, 2021 Wang b - HK cohort, 2021 Kulkarni - Quetiapine, 2024 101.22[1.01; 1.47]1,0565,895low Preeclampsia Hironaka (Control unexposed, sick), 2011 Vigod, 2015 Bellet - Aripiprazole, 2015 Petersen (Control discontinued treatment before pregnancy), 2016 Schaffer (Controls unexposed, sick), 2019 51.38[1.08; 1.76]2932,176not evaluable Postpartum hemorrhage Vigod, 2015 Frayne (Control unexposed, sick), 2018 Kananen - Quetiapine, 2023 31.14[0.70; 1.84]7,0591,248not evaluable Assisted deliveries (forceps, vacuum, ...) Sadowski, 2013 Kananen - Quetiapine, 2023 20.65[0.37; 1.15]2,448265not evaluable Abruptio placentae (retroplacental hematoma) Vigod, 2015 12.06[0.99; 4.31]441,021not evaluable Maternal hypothyroidism Sadowski, 2013 13.64[0.74; 17.85]9133not evaluable Neonatal disorders Neonatal medical care Newport, 2007 Sadowski, 2013 Sutter-Dallay, 2015 Vigod, 2015 Frayne (Control unexposed, sick), 2018 Ellfolk (Control unexposed), 2019 Schaffer (Controls unexposed, sick), 2019 Heinonen b (Controls unexposed, sick), 2022 Kananen - Quetiapine, 2023 Viguera b, 2023 Kernizan (Controls unexposed, sick), 2024 111.29[1.11; 1.51]14,0168,192low Low Apgar score (< 7) (at 5 min) Frayne (Control unexposed, sick), 2018 Ellfolk (Control unexposed), 2019 Kananen - Quetiapine, 2023 31.43[0.92; 2.21]2,2444,431not evaluable Neonatal disorders (as a whole) Habermann (Control unexposed, disease free), 2013 Petersen (Control discontinued treatment before pregnancy), 2016 22.78[0.53; 14.70]98440not evaluable Withdrawal syndrome / Neonatal abstinence syndrome / Poor neonatal adaptation Sadowski, 2013 Vigod, 2015 Kernizan, 2019 Schaffer (Controls unexposed, sick), 2019 Viguera b, 2023 51.19[0.92; 1.55]5372,615not evaluable Low Apgar score (< 7) (at 1 min) Frayne (Control unexposed, sick), 2018 Ellfolk (Control unexposed), 2019 21.38[1.14; 1.67]1,5954,279not evaluable Neonatal death (< 28 days of life) Vigod, 2015 Ellfolk (Control unexposed), 2019 Kananen - Quetiapine, 2023 31.38[0.61; 3.10]675,377not evaluable Low Apgar score (< 7) (NOS) Hironaka (Control unexposed, sick), 2011 10.29[0.00; 18.96]-9not evaluable Fetal distress Sadowski, 2013 11.45[0.70; 2.99]35113not evaluable Infant health status Wurtz, 2017 11.00[0.95; 1.05]--not evaluable Neonatal infections Vigod, 2015 10.70[0.27; 1.83]171,021not evaluable Neonatal intracranial hemorrhage Vigod, 2015 11.33[0.46; 3.84]141,021not evaluable Intrauterine deaths Early intrauterine deaths (< 22 weeks) / Spontaneous abortions Paulus, 2005 McKenna, 2005 Yaris, 2005 Vial (Control unexposed, NOS), 2009 Habermann (Control unexposed, disease free), 2013 Paulus - Aripiprazole only, 2013 Bellet - Aripiprazole, 2015 Sorensen - Olanzapine, 2015 Ozturk, 2016 Yakuwa, 2019 Ishikawa, 2024 111.03[0.91; 1.17]159,1582,473low Elective/induced termination of pregnancy Paulus, 2005 Vial (Control unexposed, NOS), 2009 Paulus - Aripiprazole only, 2013 Habermann (Control unexposed, disease free), 2013 Bellet - Aripiprazole, 2015 Ozturk, 2016 67.17[5.12; 10.04]186914not evaluable Late intrauterine deaths (> 22 weeks) / Stillbirths McKenna, 2005 Habermann (Control unexposed, disease free), 2013 Vigod, 2015 Ellfolk (Control unexposed), 2019 Kananen - Quetiapine, 2023 50.65[0.39; 1.10]2236,110not evaluable Therapeutic terminations of pregnancy McKenna, 2005 Bellet - Aripiprazole, 2015 Yakuwa, 2019 Ellfolk (Controls unexposed, NOS), 2021 41.65[0.35; 7.88]2374,119not evaluable Intrauterine deaths (as a whole or unspecified) Kernizan, 2019 Kulkarni - Quetiapine, 2024 20.96[0.15; 5.97]693not evaluable Perinatal death Schaffer (Controls unexposed, sick), 2019 11.40[0.66; 2.94]281,016not evaluable Neuro-developmental disorders ADHD (Attention deficit hyperactivity disorder): Diagnosis Wang a (Controls unexposed, NOS), 2021 Yeh, 2021 Straub, 2022 Halfdanarson (Controls unexposed, NOS), 2022 41.07[0.97; 1.17]147,82317,309not evaluable ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk Wang a (Controls unexposed, NOS), 2021 Yeh, 2021 Straub, 2022 Halfdanarson (Controls unexposed, NOS), 2022 41.07[0.97; 1.17]147,82317,309not evaluable ASD (Autism spectrum disorder): Diagnosis Wang a (Controls unexposed, NOS), 2021 Yeh, 2021 Straub, 2022 Halfdanarson (Controls unexposed, NOS), 2022 41.16[1.00; 1.35]60,75617,386not evaluable ASD (Autism spectrum disorder): Diagnosis/Risk Wang a (Controls unexposed, NOS), 2021 Yeh, 2021 Straub, 2022 Halfdanarson (Controls unexposed, NOS), 2022 41.16[1.00; 1.35]60,75617,386not evaluable Language disorders/delay Peng, 2013 Straub, 2022 Bruno - Quetiapine, 2024 31.10[0.99; 1.22]78,94413,360not evaluable Cognitive developmental disorders/delay (> 6 years old) Straub, 2022 Bruno - Quetiapine, 2024 20.83[0.53; 1.29]4,24212,192not evaluable Learning disorders Straub, 2022 Bruno - Quetiapine, 2024 21.12[0.85; 1.47]7,78513,284not evaluable Neuro-developmental disorders (as a whole) Straub, 2022 Bruno - Quetiapine, 2024 21.09[1.01; 1.17]161,15113,882not evaluable Psychomotor developmental disorders/delay Peng, 2013 Straub, 2022 21.11[0.83; 1.47]11,9239,466not evaluable Severe cognitive developmental delay (Mental retardation) (> 6 years old) Straub, 2022 Bruno - Quetiapine, 2024 20.83[0.53; 1.29]4,24212,192not evaluable Cognitive developmental disorders/delay (< 3 years old) Peng, 2013 11.33[0.44; 4.04]1478not evaluable0.0100.01.0

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