Page last updated: 2024-10-30

lamotrigine and Abnormalities, Congenital

lamotrigine has been researched along with Abnormalities, Congenital in 9 studies

Research Excerpts

ExcerptRelevanceReference
"Callers who contacted the Israeli Teratology Information Service regarding lamotrigine treatment or NTE during pregnancy between 1997 and 2008 were prospectively followed-up."7.85Is it safe to use lamotrigine during pregnancy? A prospective comparative observational study. ( Diav-Citrin, O; Finkel-Pekarsky, V; Ornoy, A; Shechtman, S; Zvi, N, 2017)
"Lamotrigine (LTG) is increasingly being prescribed in pregnancy for women with epilepsy in place of valproate (VPA), because of the teratogenic risks associated with the latter."7.76Is lamotrigine a significant human teratogen? Observations from the Australian Pregnancy Register. ( Eadie, MJ; Graham, JE; Hitchcock, AA; Lander, CM; O'Brien, TJ; Vajda, FJ, 2010)
"In 1992, the International Lamotrigine Pregnancy Registry was initiated to enroll prospectively and to monitor pregnancies exposed to lamotrigine (LTG) for the occurrence of major birth defects."7.71Preliminary results on pregnancy outcomes in women using lamotrigine. ( Eldridge, RR; Tennis, P, 2002)
"Callers who contacted the Israeli Teratology Information Service regarding lamotrigine treatment or NTE during pregnancy between 1997 and 2008 were prospectively followed-up."3.85Is it safe to use lamotrigine during pregnancy? A prospective comparative observational study. ( Diav-Citrin, O; Finkel-Pekarsky, V; Ornoy, A; Shechtman, S; Zvi, N, 2017)
"Lamotrigine (LTG) is increasingly being prescribed in pregnancy for women with epilepsy in place of valproate (VPA), because of the teratogenic risks associated with the latter."3.76Is lamotrigine a significant human teratogen? Observations from the Australian Pregnancy Register. ( Eadie, MJ; Graham, JE; Hitchcock, AA; Lander, CM; O'Brien, TJ; Vajda, FJ, 2010)
"Data from the International Lamotrigine Pregnancy Registry were analyzed to examine the effect of maximal first-trimester maternal dose of lamotrigine monotherapy on the risk of major birth defects (MBDs)."3.74Effect of dose on the frequency of major birth defects following fetal exposure to lamotrigine monotherapy in an international observational study. ( Cunnington, M; Ferber, S; Quartey, G, 2007)
"In 1992, the International Lamotrigine Pregnancy Registry was initiated to enroll prospectively and to monitor pregnancies exposed to lamotrigine (LTG) for the occurrence of major birth defects."3.71Preliminary results on pregnancy outcomes in women using lamotrigine. ( Eldridge, RR; Tennis, P, 2002)
"Seizures and intracranial hemorrhage are possible medical diseases that any obstetrician may encounter."2.49Seizures and intracranial hemorrhage. ( Alexander, JM; Wilson, KL, 2013)
"Juvenile myoclonic epilepsy is a common idiopathic generalized epileptic syndrome that includes generalized myoclonic seizures and commonly generalized tonic-clonic and generalized absence seizures."2.45The first line of therapy in a girl with juvenile myoclonic epilepsy: should it be valproate or a new agent? ( Abou-Khalil, B; Montouris, G, 2009)
"The incidence of birth defects in relation to specific AEDs was: valproate (16."1.32The Australian registry of anti-epileptic drugs in pregnancy: experience after 30 months. ( Graham, J; Hitchcock, A; Lander, C; O'Brien, TJ; Vajda, FJ, 2003)

Research

Studies (9)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's5 (55.56)29.6817
2010's4 (44.44)24.3611
2020's0 (0.00)2.80

Authors

AuthorsStudies
Diav-Citrin, O1
Shechtman, S1
Zvi, N1
Finkel-Pekarsky, V1
Ornoy, A1
Galappatthy, P1
Liyanage, CK1
Lucas, MN1
Jayasekara, DTLM1
Abhayaratna, SA1
Weeraratne, C1
De Abrew, K1
Gunaratne, PS1
Gamage, R1
Wijeyaratne, CN1
Wilson, KL1
Alexander, JM1
Dolk, H1
Jentink, J1
Loane, M1
Morris, J1
de Jong-van den Berg, LT1
Montouris, G1
Abou-Khalil, B1
Vajda, FJ2
Graham, JE1
Hitchcock, AA1
O'Brien, TJ2
Lander, CM1
Eadie, MJ1
Tennis, P1
Eldridge, RR1
Hitchcock, A1
Graham, J1
Lander, C1
Cunnington, M1
Ferber, S1
Quartey, G1

Clinical Trials (1)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Lamotrigine Pregnancy Registry (LAM05)[NCT01064297]3,416 participants (Actual)Observational2001-11-30Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Number of Infants With Major Congenital Malformations (MCMs) by Earliest Trimester of Exposure to Lamotrigine Polytherapy With Valproate

The number of infants with major congenital malformations were counted and are presented by earliest trimester of exposure to lamotrigine polytherapy with valproate. (NCT01064297)
Timeframe: Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported following assessments made in the delivery room or shortly after birth

Interventioninfants (Number)
First Exposure During First Trimester14
First Exposure During Second Trimester1
First Exposure During Third Trimester0
Unspecified Trimester of Exposure0
All Trimesters1

Number of Infants With Major Congenital Malformations (MCMs) by Earliest Trimester of Exposure to Lamotrigine Polytherapy Without Valproate

The number of infants with major congenital malformations were counted and are presented by earliest trimester of exposure to lamotrigine polytherapy without valproate. (NCT01064297)
Timeframe: Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported following assessments made in the delivery room or shortly after birth

Interventioninfants (Number)
First Exposure During First Trimester12
First Exposure During Second Trimester0
First Exposure During Third Trimester1
All Trimesters13

Number of Infants With Major Congenital Malformations by Earliest Trimester of Exposure to Lamotrigine Monotherapy

Among lamotrigine monotherapy exposures: live births, fetal deaths, induced abortions with birth defects, and live births without defects. Due to the likelihood of inconsistent identification of birth defects among spontaneous losses, fetal deaths, and induced abortions without reported birth defects, these offspring were not included in analyses. (NCT01064297)
Timeframe: Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported after assessments made in the delivery room or shortly after birth

Interventioninfants (Number)
First Exposure During First Trimester35
First Exposure During Second Trimester4
First Exposure During Third Trimester1
Unspecified Trimester of Exposure0
All Trimesters40

Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Monotherapy

The number of live births, fetal deaths, induced abortions, and spontaneous pregnancy losses were recorded according to the time at which women were first exposed to lamotrigine monotherapy. Due to inconsistent identification of major congenital malformations (MCMs) among spontaneous losses, no comment is made concerning the presence or absence of MCMs. (NCT01064297)
Timeframe: Although reports and diagnoses of major congenital malformations are accepted up to six years after the birth, the majority of malformations are reported after assessments made in the delivery room or shortly after birth

,,,
Interventioninfants (Number)
Live Birth (Birth Defects Reported)Fetal Death (Birth Defects Reported)Induced Abortion (Birth Defects Reported)Live Birth (No Birth Defects Reported)Fetal Death (No Birth Defects Reported)Induced Abortion (No Birth Defects Reported)Spontaneous Pregnancy Loss
First Exposure During First Trimester31131523103398
First Exposure During Second Trimester40091000
First Exposure During Third Trimester10017000
Unspecified Trimester of Exposure0005000

Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy With Valproate

The number of live births, fetal deaths, induced abortions, and spontaneous pregnancy losses were recorded according to the time at which women were first exposed to lamotrigine polytherapy with valproate. Due to inconsistent identification of major congenital malformations (MCMs) among spontaneous losses, no comment is made concerning the presence or absence of MCMs. (NCT01064297)
Timeframe: Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported following assessments made in the delivery room or shortly after birth

,,,
Interventioninfants (Number)
Live Birth (Birth Defects Reported)Fetal Death (Birth Defects Reported)Induced Abortion (Birth Defects Reported)Live Birth (No Birth Defects Reported)Fetal Death (No Birth Defects Reported)Induced Abortion (No Birth Defects Reported)Spontaneous Pregnancy Loss
First Exposure During First Trimester1402134146
First Exposure During Second Trimester1006100
First Exposure During Third Trimester0003000
Unspecified Trimester of Exposure0001000

Birth Outcomes by Earliest Pregnancy Trimester of Exposure to Lamotrigine Polytherapy Without Valproate

The number of live births, fetal deaths with pregnancy loss occurring >=20 weeks gestation, induced abortions, and spontaneous pregnancy losses were recorded according to the time at which women were first exposed to lamotrigine polytherapy without valproate. Due to inconsistent identification of major congenital malformations (MCMs) among spontaneous losses, no comment is made concerning the presence or absence of MCMs. Although birth defects may not have been reported, they cannot be ruled out. (NCT01064297)
Timeframe: Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported following assessments made in the delivery room or shortly after birth

,,
Interventioninfants (Number)
Live Birth (Birth Defects Reported)Fetal Death (Birth Defects Reported)Induced Abortion (Birth Defects Reported)Live Birth (No Birth Defects Reported)Fetal Death (No Birth Defects Reported)Induced Abortion (No Birth Defects Reported)Spontaneous Pregnancy Loss
First Exposure During First Trimester110141831922
First Exposure During Second Trimester00025000
First Exposure During Third Trimester1002000

Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy With Valproate According to Dose of Lamotrigine Received

The number of infants with the reported MCM following first trimester exposure to lamotrigine polytherapy with valproate were counted. (NCT01064297)
Timeframe: Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported after assessments made in the delivery room or shortly after birth

,
Interventioninfants (Number)
Hydrocephalus/spina bifidaMeningomyeloceleMicrocephalyOrofacial cleftsCardiac septal defectsTransposition of great vesselsVentricular hypoplasiaPulmonary stenosisPyloric stenosisGastroschisisClub footPolydactyly
Doses Lower Than Prescribed111201111121
Prescribed Doses000120000000

Number of Infants With the Indicated Major Congenital Malformations Following First Trimester of Exposure to Lamotrigine Polytherapy Without Valproate According to Dose of Lamotrigine Received

The number of infants with the reported MCM following first trimester exposure to lamotrigine polytherapy without valproate were counted. (NCT01064297)
Timeframe: Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported after assessments made in the delivery room or shortly after birth

,,
Interventioninfants (Number)
Neural tube defectCardiac septal defect/murmurCoarctation of aortaTetralogy of FallotEsophageal defectsHypospadiasHydroencephalopathyOmphaloceleExtra digitSkin tags on ear
Doses Higher Than Prescribed1101100011
Doses Lower Than Prescribed0000011000
Prescribed Doses0110100100

Number of Infants With the Indicated Major Congenital Malformations Following the First Trimester of Exposure to Lamotrigine Monotherapy According to Dose Received

The number of infants with the reported MCM following first trimester lamotrigine monotherapy exposure were counted. Registry personnel contacted the enrolling physician to obtain information on the pregnancy outcome, lamotrigine dosing and duration of exposure, and use of concomitant antiepileptic drugs during pregnancy. (NCT01064297)
Timeframe: Although reports and diagnoses of MCMs are accepted up to six years after the birth, the majority of malformations are reported after assessments made in the delivery room or shortly after birth

,,,
Interventioninfants (Number)
AnencephalyOrofacial cleftsHypoplastic left heart/left ventricle hypoplasiaTransposition of great vesselsVentricular septal defectsMinor heart defect, unspecifiedPulmonary stenosisHydronephrosisRenal defect (absent, polysystic, fluid on kidney)Cortical dysplasisHypospadiasPyloric stenosisDiaphragmatic herniaCongenital atresia of anusHip dislocationClub feetPolydactylyEpidermolysis bullosaLight spot across entire abdomen
Dose Higher Than Prescribed1010000020001001000
Doses Lower Than Prescribed2212000110101110110
Prescribed Doses0000311101110001101
Unknown Maximal Dose in Exposed Trimester0000000000010001000

Reviews

2 reviews available for lamotrigine and Abnormalities, Congenital

ArticleYear
Seizures and intracranial hemorrhage.
    Obstetrics and gynecology clinics of North America, 2013, Volume: 40, Issue:1

    Topics: Anticonvulsants; Carbamazepine; Congenital Abnormalities; Eclampsia; Epilepsy; Female; Folic Acid; H

2013
The first line of therapy in a girl with juvenile myoclonic epilepsy: should it be valproate or a new agent?
    Epilepsia, 2009, Volume: 50 Suppl 8

    Topics: Anticonvulsants; Congenital Abnormalities; Delayed-Action Preparations; Drug Design; Epilepsy, Gener

2009

Other Studies

7 other studies available for lamotrigine and Abnormalities, Congenital

ArticleYear
Is it safe to use lamotrigine during pregnancy? A prospective comparative observational study.
    Birth defects research, 2017, Sep-01, Volume: 109, Issue:15

    Topics: Abnormalities, Drug-Induced; Anticonvulsants; Congenital Abnormalities; Female; Humans; Lamotrigine;

2017
Obstetric outcomes and effects on babies born to women treated for epilepsy during pregnancy in a resource limited setting: a comparative cohort study.
    BMC pregnancy and childbirth, 2018, Jun-14, Volume: 18, Issue:1

    Topics: Abortion, Spontaneous; Adolescent; Adult; Anticonvulsants; Body Height; Body Weight; Carbamazepine;

2018
Does lamotrigine use in pregnancy increase orofacial cleft risk relative to other malformations?
    Neurology, 2008, Sep-02, Volume: 71, Issue:10

    Topics: Adolescent; Antimanic Agents; Case-Control Studies; Child; Child, Preschool; Cleft Lip; Community He

2008
Is lamotrigine a significant human teratogen? Observations from the Australian Pregnancy Register.
    Seizure, 2010, Volume: 19, Issue:9

    Topics: Abnormalities, Drug-Induced; Anticonvulsants; Australia; Congenital Abnormalities; Dose-Response Rel

2010
Preliminary results on pregnancy outcomes in women using lamotrigine.
    Epilepsia, 2002, Volume: 43, Issue:10

    Topics: Abnormalities, Drug-Induced; Anticonvulsants; Congenital Abnormalities; Drug Therapy, Combination; E

2002
The Australian registry of anti-epileptic drugs in pregnancy: experience after 30 months.
    Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia, 2003, Volume: 10, Issue:5

    Topics: Abortion, Induced; Anticonvulsants; Australia; Carbamazepine; Cohort Studies; Congenital Abnormaliti

2003
Effect of dose on the frequency of major birth defects following fetal exposure to lamotrigine monotherapy in an international observational study.
    Epilepsia, 2007, Volume: 48, Issue:6

    Topics: Abnormalities, Drug-Induced; Anticonvulsants; Congenital Abnormalities; Databases as Topic; Dose-Res

2007