Lamotrigine (All indications) updated on 12-01-2025

Table   Graphic     exposition period:

Congenital malformations
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
All congenital malformations (majors, minors, majors and minors, or unspecified)1.00 [0.91, 1.10]0%18 studies148,72316,598probable ROB-
Major congenital malformations1.01 [0.91, 1.10]0%17 studies148,74816,663low ROB-
Congenital heart defects1.10 [0.82, 1.48]25%7 studies2,07410,540not evaluable ROB-
Limb defects1.07 [0.75, 1.52]0%5 studies1,2692,087not evaluable ROB-
Oro-facial clefts1.78 [0.74, 4.25]84%5 studies2,96913,432not evaluable ROB-
Club foot / Talipes equinovarus1.12 [0.80, 1.57]0%4 studies3,80712,420not evaluable ROB-
Hypospadias1.14 [0.82, 1.59]0%4 studies9,48013,253not evaluable ROB-
Nervous system anomalies1.38 [0.88, 2.15]0%4 studies36710,074not evaluable ROB-
Cleft palate3.22 [0.42, 25.01]86%3 studies1,2263,681not evaluable ROB-
Neural Tube Defects0.72 [0.04, 11.59]0%2 studies352not evaluable ROB-
Spina bifida1.04 [0.25, 4.41]0%3 studies6223,928not evaluable ROB-
Cardiac septal defects1.46 [0.94, 2.26]0%2 studies16,5771,917not evaluable ROB-
Cleft lip with or without cleft palate2.30 [0.32, 16.29]69%2 studies1,7433,681not evaluable ROB-
Digestive system anomalies0.56 [0.27, 1.18]0%2 studies11,462not evaluable ROB-
Genital anomalies0.77 [0.45, 1.31]0%2 studies1,0241,685not evaluable ROB-
Microcephaly / Small head circumference for gestational age0.94 [0.83, 1.07]0%2 studies134,73611,753not evaluable ROB-
Minor congenital malformations10.14 [0.38, 267.91]-1 study112not evaluable ROB-
Urinary malformations1.16 [0.51, 2.65]0%2 studies71,462not evaluable ROB-
Ano-rectal atresia and stenosis1.15 [0.16, 8.19]-1 study5452,997not evaluable ROB-
Atrial septal defect1.50 [0.77, 2.90]-1 study3,2762,997not evaluable ROB-
Atrioventricular septal defect0.59 [0.04, 9.46]-1 study5292,997not evaluable ROB-
Bilateral renal agenesis including Potter syndrome4.15 [0.26, 66.90]-1 study752,997not evaluable ROB-
Bladder exstrophy and/or epispadia7.70 [0.52, 114.86]-1 study832,997not evaluable ROB-
Chromosomal abnormalities2.09 [0.79, 5.53]-1 study1,412not evaluable ROB-
Coarctation of aorta2.40 [0.64, 9.04]-1 study7822,997not evaluable ROB-
Craniosynostosis0.41 [0.03, 6.53]-1 study7662,997not evaluable ROB-
Diaphragmatic hernia1.66 [0.23, 11.79]-1 study3792,997not evaluable ROB-
Ebstein's anomaly6.20 [0.38, 100.48]-1 study502,997not evaluable ROB-
Eye, ear, face and neck malformations0.78 [0.32, 1.89]-1 study1,412not evaluable ROB-
Gastroschisis5.20 [0.93, 29.18]-1 study2452,997not evaluable ROB-
Hypoplastic left heart (HLH/HLHS)1.45 [0.09, 23.19]-1 study2162,997not evaluable ROB-
Hypoplastic right heart (HRH/HRHS)4.71 [0.29, 76.05]-1 study662,997not evaluable ROB-
Oesophageal atresia with or without tracheo-oesophageal fistula3.20 [0.59, 17.31]-1 study3942,997not evaluable ROB-
Omphalocele2.40 [0.21, 27.68]-1 study2672,997not evaluable ROB-
Polydactyly1.33 [0.35, 5.05]-1 study3,0871,084not evaluable ROB-
Pulmonary valve atresia2.05 [0.13, 32.97]-1 study1522,997not evaluable ROB-
Respiratory system anomalies0.85 [0.35, 2.07]-1 study1,412not evaluable ROB-
Tetralogy of Fallot0.54 [0.03, 8.57]-1 study5842,997not evaluable ROB-
Ventricular septal defect1.30 [0.69, 2.46]-1 study4,6532,997not evaluable ROB-

Growth parameters and prematurity
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Preterm (< 37 weeks)0.98 [0.82, 1.17]60%15 studies290,05810,896low ROB-
Small for gestational age (weight)0.91 [0.83, 0.99]21%8 studies656,61117,034not evaluable ROB1.42 [.; 1.08]
Low birth weight (< 2500g)1.03 [0.91, 1.16]28%5 studies264,29514,722not evaluable ROB-
Extremely preterm (< 28 weeks)0.51 [0.14, 1.87]0%2 studies2,0382,923not evaluable ROB-
Very preterm (28 to 32 weeks)0.53 [0.19, 1.45]15%2 studies8,5672,923not evaluable ROB-
Large for gestational age (weight)1.47 [0.05, 41.93]71%2 studies74180not evaluable ROB-
Macrosomia (> 4000g)0.89 [0.82, 0.97]-1 study577,1802,813not evaluable ROB1.49 [.; 1.22]

Maternal consequences
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Caesarean0.99 [0.86, 1.14]0%4 studies187,5861,888not evaluable ROB-
Preeclampsia1.09 [0.90, 1.31]0%3 studies53,7802,719not evaluable ROB-
Assisted deliveries (forceps, vacuum, ...)1.63 [1.07, 2.47]-1 study185233not evaluable ROB2.64 [1.35; .]
Postpartum hemorrhage1.20 [0.85, 1.70]72%2 studies204,0501,702not evaluable ROB-
Abruptio placentae (retroplacental hematoma)1.15 [0.85, 1.56]-1 study20,3192,682not evaluable ROB-
Amniotic fluid problems (polyhydramnios and/or oligohydramnios)3.31 [0.06, 183.69]-1 study7not evaluable ROB-
Gestational diabetes1.05 [0.04, 29.08]-1 study17not evaluable ROB-
Maternal consequences (as a whole)0.99 [0.83, 1.18]-1 study8305,080not evaluable ROB-

Neonatal disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Low Apgar score (< 7) (at 5 min)1.08 [0.81, 1.46]0%5 studies16,5212,812not evaluable ROB-
Neonatal medical care1.29 [1.05, 1.60]0%5 studies45,1681,749not evaluable ROB1.91 [1.27; .]
Neonatal disorders (as a whole)0.95 [0.85, 1.07]0%2 studies222,1572,919not evaluable ROB-
Low Apgar score (< 7) (at 1 min)1.69 [0.35, 8.14]-1 study78154not evaluable ROB-
Withdrawal syndrome / Neonatal abstinence syndrome / Poor neonatal adaptation0.65 [0.08, 5.30]-1 study1713not evaluable ROB-
Fetal distress--0 study-
Neonatal death (< 28 days of life)0.60 [0.06, 5.80]-1 study4948not evaluable ROB-

Long term consequences
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Child/Infant death (> 28 days of life)1.22 [0.65, 2.30]0%2 studies4,7102,986not evaluable ROB-

Intrauterine deaths
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
Intrauterine deaths (as a whole or unspecified)1.56 [0.79, 3.08]17%7 studies4,5133,461not evaluable ROB-
Elective/induced termination of pregnancy1.39 [0.20, 9.76]0%3 studies5988not evaluable ROB-
Early intrauterine deaths (< 22 weeks) / Spontaneous abortions1.14 [0.16, 8.05]0%2 studies650not evaluable ROB-
Late intrauterine deaths (> 22 weeks) / Stillbirths1.07 [0.13, 8.49]0%3 studies2975not evaluable ROB-
Perinatal death0.49 [0.03, 8.47]-1 study10173not evaluable ROB-
Therapeutic terminations of pregnancy0.10 [0.00, 5.62]-1 study37not evaluable ROB-

Neuro-developmental disorders
Adverse outcome OR 95%CII2k No. casesNo. exposedpublication biasROBE-value
ASD (Autism spectrum disorder): Diagnosis/Risk0.92 [0.79, 1.07]12%8 studies81,38820,060not evaluable ROB-
Language disorders/delay1.12 [0.79, 1.58]46%9 studies72,0533,181not evaluable ROB-
ADHD (Attention deficit hyperactivity disorder): Diagnosis/Risk1.14 [0.86, 1.53]64%7 studies165,14311,524not evaluable ROB-
ASD (Autism spectrum disorder): Diagnosis0.88 [0.77, 1.00]0%6 studies81,34719,901serious ROB1.55 [.; 1.06]
Neuro-developmental disorders (as a whole)1.08 [0.82, 1.42]53%7 studies12,26511,895not evaluable ROB-
Cognitive developmental disorders/delay (> 6 years old)0.99 [0.80, 1.21]0%6 studies24,64311,375not evaluable ROB-
ADHD (Attention deficit hyperactivity disorder): Diagnosis0.91 [0.74, 1.11]40%4 studies153,28211,292not evaluable ROB-
Cognitive developmental disorders/delay (3-6 years old)1.81 [0.66, 4.98]87%5 studies3,56910,842not evaluable ROB-
Psychomotor developmental disorders/delay1.30 [0.47, 3.59]72%6 studies14262not evaluable ROB-
Severe cognitive developmental delay (Mental retardation) (> 6 years old)1.02 [0.82, 1.27]0%3 studies24,60111,262not evaluable ROB-
Cognitive developmental disorders/delay (< 3 years old)1.55 [0.68, 3.52]33%4 studies11141not evaluable ROB-
Severe cognitive developmental delay (Mental retardation) (3-6 years old)0.98 [0.26, 3.76]90%3 studies3,56710,798not evaluable ROB-
ADHD (Attention deficit hyperactivity disorder): Risk1.81 [1.17, 2.79]0%3 studies11,861232not evaluable ROB3.01 [1.61; .]
ASD (Autism spectrum disorder): Risk1.64 [0.66, 4.06]6%2 studies41159not evaluable ROB-
Learning disorders 0.92 [0.74, 1.13]0%2 studies9275not evaluable ROB-
Childhood autism (F84.0)1.70 [0.53, 5.48]-1 study2,066647not evaluable ROB-

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