Lamotrigine (Epilepsy)

Table   Graphic  
individual studies
OutcomeTE95% CIn casesn exposedkPub. bias Congenital malformations All congenital malformations (majors, minors, majors and minors, or unspecified) Holmes, 2008 Mawer (Controls unexposed, sick), 2010 Charlton, 2011 Rihtman, 2013 Cassina, 2013 Campbell, 2014 Veiby (Controls unexposed, sick), 2014 Vanya (Controls unexposed, sick), 2015 Petersen (Controls unexposed, sick), 2017 Alsaadi (Controls unexposed sick), 2020 Meador (Controls unexposed, sick), 2020 Aydin, 2020 Thomas (Controls unexposed, sick), 2021 Hosny, 2021 Wiggs, 2024 Vajda, 2025 Hao, 2025 171.13[0.93; 1.37]4496,093low Major congenital malformations Holmes, 2008 Mawer (Controls unexposed, sick), 2010 Charlton, 2011 Cassina, 2013 Campbell, 2014 Veiby (Controls unexposed, sick), 2014 Vanya (Controls unexposed, sick), 2015 Petersen (Controls unexposed, sick), 2017 Diav-Citrin, 2017 Meador (Controls unexposed, sick), 2020 Alsaadi (Controls unexposed sick), 2020 Thomas (Controls unexposed, sick), 2021 Hosny, 2021 Wiggs, 2024 Vajda, 2025 Hao, 2025 161.14[0.94; 1.38]4746,158low Congenital heart defects Mawer (Controls unexposed, sick), 2010 Vajda, 2013 Diav-Citrin, 2017 Thomas (Controls unexposed, sick), 2021 Wiggs, 2024 51.01[0.71; 1.45]261,928not evaluable Limb defects Mawer (Controls unexposed, sick), 2010 Vajda, 2013 Thomas (Controls unexposed, sick), 2021 Wiggs, 2024 41.04[0.72; 1.50]41,814not evaluable Neural Tube Defects Mawer (Controls unexposed, sick), 2010 Vajda, 2013 20.72[0.04; 11.59]-352not evaluable Digestive system anomalies Thomas (Controls unexposed, sick), 2021 Wiggs, 2024 20.56[0.27; 1.18]11,462not evaluable Minor congenital malformations Alsaadi (Controls unexposed sick), 2020 110.14[0.38; 267.91]112not evaluable Nervous system anomalies Thomas (Controls unexposed, sick), 2021 Wiggs, 2024 21.13[0.27; 4.77]-1,462not evaluable Oro-facial clefts Holmes, 2008 Wiggs, 2024 24.39[0.75; 25.72]1502,096not evaluable Spina bifida Charlton, 2011 Veiby (Controls unexposed, sick), 2014 21.28[0.15; 10.73]5691not evaluable Urinary malformations Thomas (Controls unexposed, sick), 2021 Wiggs, 2024 21.16[0.51; 2.65]71,462not evaluable Chromosomal abnormalities Wiggs, 2024 12.09[0.79; 5.53]-1,412not evaluable Cleft lip with or without cleft palate Holmes, 2008 15.93[1.46; 24.07]104684not evaluable Cleft palate Holmes, 2008 121.00[6.79; 64.98]46684not evaluable Eye, ear, face and neck malformations Wiggs, 2024 10.78[0.32; 1.89]-1,412not evaluable Genital anomalies Wiggs, 2024 10.76[0.44; 1.32]-1,412not evaluable Microcephaly / Small head circumference for gestational age Christensen (Lamotrigine) (Epilepsy), 2024 10.88[0.73; 1.06]8505,299not evaluable Respiratory system anomalies Wiggs, 2024 10.85[0.35; 2.07]-1,412not evaluable Growth parameters and prematurity Preterm (< 37 weeks) Cummings, 2011 Artama (Controls unexposed, sick), 2013 Veiby (Controls unexposed, sick) b, 2013 Miškov (Controls unexposed, sick), 2016 Cohen, 2019 Aydin, 2020 Van Marter (Controls unexposed, sick), 2021 Bromley (Lamotrigine) (Epilepsy), 2023 Leite, 2024 90.97[0.75; 1.26]160,859565not evaluable Small for gestational age (weight) Veiby (Controls unexposed, sick) b, 2013 Cohen, 2019 Aydin, 2020 Van Marter (Controls unexposed, sick), 2021 Bromley (Lamotrigine) (Epilepsy), 2023 Christensen (Lamotrigine) (Epilepsy), 2024 60.93[0.84; 1.03]44,6695,621not evaluable Large for gestational age (weight) Artama (Controls unexposed, sick), 2013 Aydin, 2020 21.47[0.05; 41.93]74180not evaluable Low birth weight (< 2500g) Veiby (Controls unexposed, sick) b, 2013 Christensen (Lamotrigine) (Epilepsy), 2024 20.98[0.84; 1.14]1,2585,402not evaluable Extremely preterm (< 28 weeks) Van Marter (Controls unexposed, sick), 2021 10.13[0.00; 6.93]-110not evaluable Very preterm (28 to 32 weeks) Van Marter (Controls unexposed, sick), 2021 10.13[0.01; 2.17]2110not evaluable Maternal consequences Caesarean Borthen (Controls unexposed, sick), 2010 Artama (Controls unexposed, sick), 2013 21.00[0.77; 1.31]744406not evaluable Preeclampsia Borthen (Controls unexposed, sick), 2011 Cohen, 2019 Aydin, 2020 31.62[0.98; 2.68]53,64237not evaluable Assisted deliveries (forceps, vacuum, ...) Borthen (Controls unexposed, sick), 2010 11.63[1.07; 2.47]185233not evaluable Postpartum hemorrhage Borthen (Controls unexposed, sick), 2010 11.49[1.06; 2.10]324233not evaluable Abruptio placentae (retroplacental hematoma) Cohen, 2019 10.77[0.25; 2.35]20,260-not evaluable Amniotic fluid problems (polyhydramnios and/or oligohydramnios) Aydin, 2020 13.31[0.06; 183.69]-7not evaluable Gestational diabetes Aydin, 2020 11.05[0.04; 29.08]17not evaluable Maternal consequences (as a whole) Razaz (Lamotrigine), 2024 10.99[0.83; 1.18]8305,080not evaluable Neonatal disorders Low Apgar score (< 7) (at 5 min) Borthen (Controls unexposed, sick), 2010 Artama (Controls unexposed, sick), 2013 Veiby (Controls unexposed, sick) b, 2013 31.63[0.85; 3.14]54468not evaluable Neonatal medical care Artama (Controls unexposed, sick), 2013 Aydin, 2020 Bromley (Lamotrigine) (Epilepsy), 2023 32.08[1.10; 3.93]206267not evaluable Low Apgar score (< 7) (at 1 min) Artama (Controls unexposed, sick), 2013 11.69[0.35; 8.14]78154not evaluable Fetal distress 0----- Neonatal disorders (as a whole) Bromley (Lamotrigine) (Epilepsy), 2023 11.20[0.58; 2.48]38106not evaluable Withdrawal syndrome / Neonatal abstinence syndrome / Poor neonatal adaptation 0----- Long term consequences Child/Infant death (> 28 days of life) Artama (Controls unexposed, sick), 2013 12.33[0.19; 28.62]6173not evaluable Intrauterine deaths Intrauterine deaths (as a whole or unspecified) Miškov (Controls unexposed, sick), 2016 Trivedi, 2018 Meador (Controls unexposed, sick), 2020 Vajda, 2024 44.27[1.04; 17.51]26524not evaluable Early intrauterine deaths (< 22 weeks) / Spontaneous abortions Miškov (Controls unexposed, sick), 2016 Alsaadi (Controls unexposed sick), 2020 21.14[0.16; 8.05]650not evaluable Elective/induced termination of pregnancy Miškov (Controls unexposed, sick), 2016 Hosny, 2021 21.25[0.05; 31.47]140not evaluable Late intrauterine deaths (> 22 weeks) / Stillbirths AlSheikh, 2020 Aydin, 2020 21.13[0.07; 19.22]-27not evaluable Perinatal death Artama (Controls unexposed, sick), 2013 10.49[0.03; 8.47]10173not evaluable Therapeutic terminations of pregnancy Miškov (Controls unexposed, sick), 2016 10.10[0.00; 5.62]-37not evaluable Neuro-developmental disorders Language disorders/delay Rihtman, 2013 Baker (Controls unexposed, sick), 2015 Videman, 2016 Kasradze, 2017 Cohen-Israel, 2018 Husebye (Controls unexposed, sick), 2020 Bromley (Lamotrigine) (Epilepsy), 2023 Meador, 2023 81.12[0.69; 1.84]72368not evaluable ASD (Autism spectrum disorder): Diagnosis/Risk Bromley (Controls unexposed, sick), 2013 Cohen-Israel, 2018 Bjørk (Controls unexposed, sick), 2018 Dreier, 2023 Hernandez-Diaz, 2024 Madley-Dowd_UK (Lamotrigine) (Epilepsy), 2024 Madley-Dowd_SE (Lamotrigine) (Controls unexposed, sick), 2024 70.91[0.77; 1.08]1,13611,785not evaluable ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk Rihtman, 2013 Veiby (Controls unexposed, sick) b, 2013 Bromley (Controls unexposed, sick), 2013 Dreier, 2023 Madley-Dowd_UK (Lamotrigine) (Epilepsy), 2024 Madley-Dowd_SE (Lamotrigine) (Controls unexposed, sick), 2024 60.95[0.74; 1.22]1,7208,575not evaluable Neuro-developmental disorders (as a whole) Dean, 2007 Rihtman, 2013 Bromley (Controls unexposed, sick), 2013 Charlton (Controls unexposed, sick), 2017 Bjørk (Controls unexposed, sick), 2022 50.84[0.66; 1.06]5405,271not evaluable ASD (Autism spectrum disorder): Diagnosis Bromley (Controls unexposed, sick), 2013 Dreier, 2023 Madley-Dowd_UK (Lamotrigine) (Epilepsy), 2024 Madley-Dowd_SE (Lamotrigine) (Controls unexposed, sick), 2024 Hernandez-Diaz, 2024 50.88[0.73; 1.04]1,09511,626not evaluable Cognitive developmental disorders/delay (> 6 years old) Gopinath, 2015 Baker (Controls unexposed, sick), 2015 Cohen-Israel, 2018 Dreier, 2023 Madley-Dowd_UK (Lamotrigine) (Epilepsy), 2024 Madley-Dowd_SE (Lamotrigine) (Controls unexposed, sick), 2024 60.99[0.78; 1.26]4928,575not evaluable Psychomotor developmental disorders/delay Rihtman, 2013 Bromley (Controls unexposed, sick), 2013 Videman, 2016 Cohen-Israel, 2018 Thomas (Lamotrigine) (Epilepsy), 2022 Bromley (Lamotrigine) (Epilepsy), 2023 61.30[0.47; 3.59]14262not evaluable ADHD (Attention deficit hyperactivity disorder): Diagnosis Bromley (Controls unexposed, sick), 2013 Dreier, 2023 Madley-Dowd_SE (Lamotrigine) (Controls unexposed, sick), 2024 Madley-Dowd_UK (Lamotrigine) (Epilepsy), 2024 40.89[0.70; 1.13]1,7138,492not evaluable Cognitive developmental disorders/delay (< 3 years old) Bromley (Controls unexposed, sick), 2010 Videman, 2016 Thomas (Lamotrigine) (Epilepsy), 2022 Bromley (Lamotrigine) (Epilepsy), 2023 41.55[0.68; 3.52]11141not evaluable Cognitive developmental disorders/delay (3-6 years old) Cummings, 2011 Rihtman, 2013 Kasradze, 2017 Bjørk (Controls unexposed, sick), 2022 41.80[0.60; 5.41]1635,152not evaluable ADHD (Attention deficit hyperactivity disorder): Risk Rihtman, 2013 Veiby (Controls unexposed, sick) b, 2013 21.42[0.72; 2.78]783not evaluable ASD (Autism spectrum disorder): Risk Cohen-Israel, 2018 Bjørk (Controls unexposed, sick), 2018 21.64[0.66; 4.06]41159not evaluable Learning disorders Cohen-Israel, 2018 Ren (Lamotrigine) (Epilepsy), 2023 20.87[0.69; 1.09]9249not evaluable Severe cognitive developmental delay (Mental retardation) (3-6 years old) Cummings, 2011 Bjørk (Controls unexposed, sick), 2022 20.72[0.46; 1.14]1615,108not evaluable Severe cognitive developmental delay (Mental retardation) (> 6 years old) Dreier, 2023 Madley-Dowd_UK (Lamotrigine) (Epilepsy), 2024 Madley-Dowd_SE (Lamotrigine) (Controls unexposed, sick), 2024 31.05[0.77; 1.43]4508,462not evaluable0.0100.01.0

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