Proton Pump Inhibitors

Table   Graphic  
individual studies
OutcomeTE95% CIn casesn exposedkPub. bias Congenital malformations All congenital malformations (majors, minors, majors and minors, or unspecified) Lalkin - Omeprazole (Controls unexposed NOS), 1998 Ruigomez - Omeprazole (Controls unexposed NOS), 1999 Nielsen, 1999 Källén - Omeprazole, 2001 Moretti, 2002 Diav-Citrin, 2005 Pasternak, 2010 Colvin, 2011 Matok, 2012 Choi a, 2023 101.07[1.02; 1.12]120,80247,198low Major congenital malformations Lalkin - Omeprazole (Controls unexposed NOS), 1998 Moretti, 2002 Diav-Citrin, 2005 Pasternak, 2010 Colvin, 2011 Matok, 2012 Choi a, 2023 71.07[1.02; 1.13]120,02046,158not evaluable Congenital heart defects Ruigomez - Omeprazole (Controls unexposed NOS), 1999 Källén, 2003 Matok, 2012 Choi a, 2023 41.09[1.01; 1.17]51,19243,701not evaluable Hypospadias Källèn, 1998 Ruigomez - Omeprazole (Controls unexposed NOS), 1999 Pasternak, 2010 Anderka, 2012 Choi a, 2023 51.37[0.67; 2.79]2,48624,977not evaluable Cleft palate Ruigomez - Omeprazole (Controls unexposed NOS), 1999 Pasternak, 2010 Anderka, 2012 Choi a, 2023 41.17[0.75; 1.83]2,84544,348not evaluable Club foot / Talipes equinovarus Ruigomez - Omeprazole (Controls unexposed NOS), 1999 Pasternak, 2010 Werler, 2014 31.30[0.75; 2.25]5733,816not evaluable Congenital hydronephrosis Källèn, 1998 Ruigomez - Omeprazole (Controls unexposed NOS), 1999 Pasternak, 2010 30.60[0.27; 1.32]34,065not evaluable Atrial septal defect Källèn, 1998 Pasternak, 2010 Matok, 2012 31.28[0.90; 1.81]7715,085not evaluable Cardiac septal defects Ruigomez - Omeprazole (Controls unexposed NOS), 1999 Choi a, 2023 22.33[0.36; 14.99]33,91140,679not evaluable Cleft lip with or without cleft palate Ruigomez - Omeprazole (Controls unexposed NOS), 1999 Pasternak, 2010 20.70[0.07; 7.28]13,790not evaluable Down syndrom / Trisomy 21 Källèn, 1998 Ruigomez - Omeprazole (Controls unexposed NOS), 1999 24.12[0.34; 49.29]1414not evaluable Eye defects Ruigomez - Omeprazole (Controls unexposed NOS), 1999 Choi a, 2023 20.97[0.67; 1.40]2,09440,679not evaluable Limb defects Ruigomez - Omeprazole (Controls unexposed NOS), 1999 Choi a, 2023 21.07[0.93; 1.22]13,71540,679not evaluable Microcephaly / Small head circumference for gestational age Ruigomez - Omeprazole (Controls unexposed NOS), 1999 Kerr, 2018 21.52[0.42; 5.56]138166not evaluable Nervous system anomalies Ruigomez - Omeprazole (Controls unexposed NOS), 1999 Choi a, 2023 21.24[1.00; 1.55]4,79040,679not evaluable Polydactyly Ruigomez - Omeprazole (Controls unexposed NOS), 1999 Pasternak, 2010 20.97[0.27; 3.48]43,790not evaluable Syndactyly Ruigomez - Omeprazole (Controls unexposed NOS), 1999 Pasternak, 2010 21.28[0.04; 37.41]-3,790not evaluable Ventricular septal defect Källèn, 1998 Pasternak, 2010 Matok, 2012 31.09[0.76; 1.56]1,1975,085not evaluable Bilateral renal agenesis including Potter syndrome Ruigomez - Omeprazole (Controls unexposed NOS), 1999 13.79[0.15; 93.41]1139not evaluable Genetic syndromes and microdeletions Ruigomez - Omeprazole (Controls unexposed NOS), 1999 11.26[0.07; 23.52]4139not evaluable Hip dislocation and/or dysplasia Ruigomez - Omeprazole (Controls unexposed NOS), 1999 11.89[0.23; 15.85]7139not evaluable Hydrocephaly Munch, 2014 Choi a, 2023 21.47[0.60; 3.60]1,27248,302not evaluable Abdominal wall defects Choi a, 2023 12.74[1.14; 6.58]23640,540not evaluable Aortic valve atresia/stenosis Matok, 2012 11.93[0.47; 7.92]951,159not evaluable Digestive system anomalies Choi a, 2023 11.25[0.99; 1.58]4,69240,540not evaluable Ear, face and neck anomalies Choi a, 2023 10.68[0.29; 1.60]43740,540not evaluable Encephalocele Källèn, 1998 10.23[0.01; 5.68]1275not evaluable Genital anomalies Choi a, 2023 10.96[0.69; 1.34]2,58940,540not evaluable Hypoplastic left heart (HLH/HLHS) Matok, 2012 12.99[0.39; 22.79]201,159not evaluable Limb reduction defects (LRD) Pasternak, 2010 10.40[0.05; 3.11]-3,651not evaluable Mitral valve anomalies Matok, 2012 15.57[0.69; 44.76]121,159not evaluable Oro-facial clefts Choi a, 2023 10.94[0.70; 1.27]3,26940,540not evaluable Patent ductus arterious Källèn, 1998 12.09[0.08; 51.57]1275not evaluable Pulmonary valve atresia Matok, 2012 13.00[0.40; 22.50]311,159not evaluable Respiratory system anomalies Choi a, 2023 11.77[1.12; 2.79]89140,540not evaluable Tetralogy of Fallot Matok, 2012 12.80[0.87; 8.98]921,159not evaluable Tricuspid atresia and stenosis Matok, 2012 10.86[0.12; 6.20]521,159not evaluable Urinary malformations Choi a, 2023 10.97[0.83; 1.14]11,36740,540not evaluable Growth parameters and prematurity Preterm (< 37 weeks) Lalkin - Omeprazole (Controls unexposed NOS), 1998 Ruigomez - Omeprazole (Controls unexposed NOS), 1999 Nielsen, 1999 Diav-Citrin, 2005 Matok, 2012 Saleh, 2017 Cluver - Esomeprazole, 2018 Breddels, 2022 81.18[0.93; 1.51]8,2811,363not evaluable Low birth weight (< 2500g) Nielsen, 1999 Källén - Omeprazole, 2001 Matok, 2012 Saleh, 2017 Choi b, 2023 50.95[0.90; 0.99]116,12842,409not evaluable Small for gestational age (weight) Ruigomez - Omeprazole (Controls unexposed NOS), 1999 Cluver - Esomeprazole, 2018 Breddels, 2022 31.12[0.86; 1.46]8998not evaluable Very preterm (28 to 32 weeks) Nielsen, 1999 Saleh, 2017 20.64[0.29; 1.40]29391not evaluable Extremely preterm (< 28 weeks) Cluver - Esomeprazole, 2018 11.13[0.64; 1.99]-59not evaluable Large for gestational age (weight) Breddels, 2022 10.87[0.70; 1.08]--not evaluable Very low birth weight (< 1500g) Matok, 2012 10.17[0.02; 1.32]1,394666not evaluable Maternal consequences Preeclampsia Cluver - Esomeprazole, 2018 Hastie, 2019 Choi (Controls unexposed NOS), 2021 Van Gelder, 2022 Breddels, 2022 51.08[0.87; 1.34]18,98245,317not evaluable Caesarean Lalkin - Omeprazole (Controls unexposed NOS), 1998 10.97[0.48; 1.98]3891not evaluable Postpartum hemorrhage Saleh, 2017 Cluver - Esomeprazole, 2018 20.54[0.15; 1.91]1499not evaluable Abruptio placentae (retroplacental hematoma) Cluver - Esomeprazole, 2018 10.07[0.00; 1.28]659not evaluable Gestational diabetes Breddels, 2022 11.20[1.00; 1.44]--not evaluable Maternal consequences (as a whole) Cluver - Esomeprazole, 2018 10.24[0.03; 2.23]559not evaluable Neonatal disorders Low Apgar score (< 7) (at 5 min) Matok, 2012 Cluver - Esomeprazole, 2018 Breddels, 2022 30.60[0.30; 1.23]1,06859not evaluable Bone fractures / bone mineralisation anomalies Wolfe (Controls unexposed NOS), 2019 10.73[0.59; 0.90]4,47210,547not evaluable Neonatal infections Saleh, 2017 Cluver - Esomeprazole, 2018 20.62[0.05; 7.91]2799not evaluable Neonatal medical care Saleh, 2017 Cluver - Esomeprazole, 2018 21.43[0.75; 2.75]6599not evaluable Fetal distress Cluver - Esomeprazole, 2018 11.18[0.57; 2.43]5459not evaluable Low Apgar score (< 7) (at 1 min) Matok, 2012 10.80[0.57; 1.12]6,185-not evaluable Necrotizing enterocolitis Cluver - Esomeprazole, 2018 11.38[0.30; 6.46]759not evaluable Neonatal death (< 28 days of life) Cluver - Esomeprazole, 2018 10.76[0.26; 2.20]1659not evaluable Neonatal disorders (as a whole) Cluver - Esomeprazole, 2018 10.91[0.35; 2.34]2159not evaluable Neonatal intracranial hemorrhage Cluver - Esomeprazole, 2018 15.27[0.25; 112.09]259not evaluable Long term consequences Infant asthma Andersen (Controls unexposed NOS), 2012 Hak, 2013 Mulder, 2014 Yitshak-Sade, 2016 Cea Soriano, 2016 Malaeb, 2021 Noh, 2023 71.23[1.01; 1.49]30,15642,401not evaluable Infant allergies Dehlink (Controls unexposed NOS), 2009 Mulder, 2014 Noh, 2023 31.21[0.91; 1.61]38,03139,764not evaluable Intrauterine deaths Late intrauterine deaths (> 22 weeks) / Stillbirths Ruigomez - Omeprazole (Controls unexposed NOS), 1999 Nielsen, 1999 Diav-Citrin, 2005 Saleh, 2017 Cluver - Esomeprazole, 2018 51.60[0.56; 4.54]73700not evaluable Early intrauterine deaths (< 22 weeks) / Spontaneous abortions Lalkin - Omeprazole (Controls unexposed NOS), 1998 Diav-Citrin, 2005 21.29[0.84; 1.97]114524not evaluable Intrauterine deaths (as a whole or unspecified) Andersen (Controls unexposed, NOS), 2013 11.03[0.90; 1.17]-3,577not evaluable Perinatal death Källén - Omeprazole, 2001 Matok, 2012 20.80[0.16; 3.98]1,3501,529not evaluable Therapeutic terminations of pregnancy Lalkin - Omeprazole (Controls unexposed NOS), 1998 11.21[0.36; 4.09]11113not evaluable Ectopic pregnancy 0----- Elective/induced termination of pregnancy Diav-Citrin, 2005 12.99[1.79; 5.00]63411not evaluable Neuro-developmental disorders Neuro-developmental disorders (as a whole) Fejzo - Lansoprazole, 2015 12.00[0.87; 4.60]13825not evaluable0.0100.01.0

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