Pregabalin (All indications)

Table   Graphic  
individual studies
OutcomeTE95% CIn casesn exposedkPub. bias Congenital malformations All congenital malformations (majors, minors, majors and minors, or unspecified) Källén (Controls unexposed, NOS) (Indications NOS), 2013 Veiby (Controls unexposed, sick) (Mixed indications), 2014 Winterfeld (Other indications), 2016 Patorno (Other indications), 2017 Tomson, 2018 Vajda (Controls unexposed, sick), 2019 The NAAED (Controls unexposed, disease free) (Indications NOS), 2022 71.74[0.77; 3.95]115,745686not evaluable Major congenital malformations Källén (Controls unexposed, NOS) (Indications NOS), 2013 Veiby (Controls unexposed, sick) (Mixed indications), 2014 Winterfeld (Other indications), 2016 Patorno (Other indications), 2017 Tomson, 2018 Vajda (Controls unexposed, sick), 2019 The NAAED (Controls unexposed, disease free) (Indications NOS), 2022 71.74[0.77; 3.95]115,745686not evaluable Oro-facial clefts Veiby (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 Blotière (Controls unexposed NOS) (Other indications), 2019 21.89[0.35; 10.09]2,8191,701not evaluable Microcephaly / Small head circumference for gestational age Blotière (Controls unexposed NOS) (Other indications), 2019 11.28[0.08; 20.51]4381,671not evaluable Spina bifida Veiby (Controls unexposed, sick) (Mixed indications), 2014 Blotière (Controls unexposed NOS) (Other indications), 2019 24.33[0.49; 38.62]6201,701not evaluable Ano-rectal atresia and stenosis Blotière (Controls unexposed NOS) (Other indications), 2019 12.10[0.19; 22.62]5451,671not evaluable Atrial septal defect Blotière (Controls unexposed NOS) (Other indications), 2019 11.90[0.84; 4.30]3,2741,671not evaluable Atrioventricular septal defect Blotière (Controls unexposed NOS) (Other indications), 2019 11.06[0.07; 16.98]5291,671not evaluable Bilateral renal agenesis including Potter syndrome Blotière (Controls unexposed NOS) (Other indications), 2019 17.44[0.46; 120.03]751,671not evaluable Bladder exstrophy and/or epispadia Blotière (Controls unexposed NOS) (Other indications), 2019 16.80[0.42; 109.76]821,671not evaluable Cleft lip with or without cleft palate Blotière (Controls unexposed NOS) (Other indications), 2019 10.69[0.10; 4.87]1,6381,671not evaluable Cleft palate Blotière (Controls unexposed NOS) (Other indications), 2019 11.90[0.32; 11.16]1,1801,671not evaluable Club foot / Talipes equinovarus Blotière (Controls unexposed NOS) (Other indications), 2019 10.33[0.02; 5.35]1,6771,671not evaluable Coarctation of aorta Blotière (Controls unexposed NOS) (Other indications), 2019 15.80[1.90; 17.70]7831,671not evaluable Congenital heart defects 0----- Craniosynostosis Blotière (Controls unexposed NOS) (Other indications), 2019 14.40[1.16; 16.72]7691,671not evaluable Diaphragmatic hernia Blotière (Controls unexposed NOS) (Other indications), 2019 11.48[0.09; 23.76]3781,671not evaluable Digestive system anomalies 0----- Ebstein's anomaly Blotière (Controls unexposed NOS) (Other indications), 2019 111.12[0.69; 180.27]501,671not evaluable Eye defects 0----- Gastroschisis Blotière (Controls unexposed NOS) (Other indications), 2019 12.31[0.14; 36.98]2431,671not evaluable Genital anomalies 0----- Hypoplastic left heart (HLH/HLHS) Blotière (Controls unexposed NOS) (Other indications), 2019 15.20[0.30; 89.16]2171,671not evaluable Hypoplastic right heart (HRH/HRHS) Blotière (Controls unexposed NOS) (Other indications), 2019 18.44[0.52; 136.44]661,671not evaluable Hypospadias Blotière (Controls unexposed NOS) (Other indications), 2019 10.70[0.14; 3.57]3,3731,671not evaluable Limb defects 0----- Nervous system anomalies 0----- Oesophageal atresia with or without tracheo-oesophageal fistula Blotière (Controls unexposed NOS) (Other indications), 2019 11.43[0.09; 22.91]3921,671not evaluable Omphalocele Blotière (Controls unexposed NOS) (Other indications), 2019 12.11[0.13; 33.78]2661,671not evaluable Pulmonary valve atresia Blotière (Controls unexposed NOS) (Other indications), 2019 13.68[0.23; 59.15]1521,671not evaluable Tetralogy of Fallot Blotière (Controls unexposed NOS) (Other indications), 2019 10.96[0.06; 15.38]5841,671not evaluable Urinary malformations 0----- Ventricular septal defect Blotière (Controls unexposed NOS) (Other indications), 2019 11.10[0.46; 2.60]4,6481,671not evaluable Respiratory system anomalies 0----- Growth parameters and prematurity Low birth weight (< 2500g) Kilic (Controls unexposed, sick) (Mixed indications), 2014 Coste (Controls unexposed, NOS) (Mixed indications), 2020 21.67[0.79; 3.54]91,8241,640not evaluable Preterm (< 37 weeks) Kilic (Controls unexposed, sick) (Mixed indications), 2014 Coste (Controls unexposed, NOS) (Mixed indications), 2020 21.83[0.67; 5.00]91,7511,640not evaluable Small for gestational age (weight) Kilic (Controls unexposed, sick) (Mixed indications), 2014 Coste (Controls unexposed, NOS) (Mixed indications), 2020 21.22[0.77; 1.93]168,1501,640not evaluable Macrosomia (> 4000g) Coste (Controls unexposed, NOS) (Mixed indications), 2020 11.02[0.92; 1.13]577,6521,627not evaluable Very preterm (28 to 32 weeks) Coste (Controls unexposed, NOS) (Mixed indications), 2020 11.10[0.57; 2.12]8,5931,627not evaluable Extremely preterm (< 28 weeks) Coste (Controls unexposed, NOS) (Mixed indications), 2020 11.55[0.50; 4.80]2,0441,627not evaluable Neonatal disorders Low Apgar score (< 7) (at 5 min) 0----- Neonatal disorders (as a whole) Coste (Controls unexposed, NOS) (Mixed indications), 2020 11.11[0.96; 1.27]222,4321,627not evaluable Long term consequences Child/Infant death (> 28 days of life) Coste (Controls unexposed, NOS) (Mixed indications), 2020 10.90[0.34; 2.39]4,6991,627not evaluable Intrauterine deaths Late intrauterine deaths (> 22 weeks) 0----- Neuro-developmental disorders ASD (Autism spectrum disorder): Diagnosis Coste (Controls unexposed, NOS) (Mixed indications), 2020 Bjørk (Controls unexposed, sick) (Other indications), 2022 20.99[0.56; 1.74]4,5703,293not evaluable ASD (Autism spectrum disorder): Diagnosis/Risk Coste (Controls unexposed, NOS) (Mixed indications), 2020 Bjørk (Controls unexposed, sick) (Other indications), 2022 20.99[0.56; 1.74]4,5703,293not evaluable Neuro-developmental disorders (as a whole) Coste (Controls unexposed, NOS) (Mixed indications), 2020 Bjørk (Controls unexposed, sick) (Other indications), 2022 20.95[0.54; 1.68]10,4943,293not evaluable Cognitive developmental disorders/delay (3-6 years old) Coste (Controls unexposed, NOS) (Mixed indications), 2020 11.70[0.80; 3.61]3,4051,627not evaluable Cognitive developmental disorders/delay (> 6 years old) Bjørk (Controls unexposed, sick) (Other indications), 2022 10.47[0.19; 1.14]1441,666not evaluable Language disorders/delay Coste (Controls unexposed, NOS) (Mixed indications), 2020 10.90[0.69; 1.18]72,0731,627not evaluable Severe cognitive developmental delay (Mental retardation) (3-6 years old) Coste (Controls unexposed, NOS) (Mixed indications), 2020 11.70[0.80; 3.61]3,4051,627not evaluable Severe cognitive developmental delay (Mental retardation) (> 6 years old) Bjørk (Controls unexposed, sick) (Other indications), 2022 10.47[0.19; 1.14]1441,666not evaluable ADHD (Attention deficit hyperactivity disorder): Diagnosis 0----- ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk 0-----0.0100.01.0

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