Document Detail

Lamotrigine and the risk of malformations in pregnancy.
MedLine Citation:
PMID:  15781807     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: To report the frequency of major malformations in lamotrigine-exposed pregnancies from September 1, 1992, through March 31, 2004, in the International Lamotrigine Pregnancy Registry.
METHODS: Health care professionals throughout the world can voluntarily enroll lamotrigine-exposed pregnancies in this observational study. Only pregnancies with unknown outcomes at the time of enrollment were included in the analysis. The percentage of outcomes with major birth defects was calculated as the total number of outcomes with major birth defects divided by the sum of the number of outcomes with major birth defects + the number of live births without defects.
RESULTS: Among 414 first-trimester exposures to lamotrigine monotherapy, 12 outcomes with major birth defects were reported (2.9%, 95% CI 1.6% to 5.1%). Among the 88 first-trimester exposures to lamotrigine polytherapy including valproate, 11 outcomes with major birth defects were reported (12.5%; 95% CI 6.7% to 21.7%). Among 182 first-trimester exposures to lamotrigine polytherapy excluding valproate, 5 outcomes with major birth defects were reported (2.7%, 95% CI 1.0% to 6.6%). No distinctive pattern of major birth defects was apparent among the offspring exposed to lamotrigine monotherapy or polytherapy.
CONCLUSIONS: The risk of all major birth defects after first-trimester exposure to lamotrigine monotherapy (2.9%) was similar to that in the general population and in other registries enrolling women exposed to antiepileptic monotherapy (3.3% to 4.5%). However, the sample size was too small to detect any but very large increases in specific birth defects.
Marianne Cunnington; Patricia Tennis;
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Neurology     Volume:  64     ISSN:  1526-632X     ISO Abbreviation:  Neurology     Publication Date:  2005 Mar 
Date Detail:
Created Date:  2005-03-22     Completed Date:  2006-02-22     Revised Date:  2013-08-21    
Medline Journal Info:
Nlm Unique ID:  0401060     Medline TA:  Neurology     Country:  United States    
Other Details:
Languages:  eng     Pagination:  955-60     Citation Subset:  AIM; IM    
GlaxoSmithKline, Worldwide Epidemiology, Harlow, UK.
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MeSH Terms
Abnormalities, Drug-Induced / epidemiology*
Anticonvulsants / adverse effects*
Europe / epidemiology
Infant, Newborn
Pregnancy Trimester, First / drug effects
Prenatal Exposure Delayed Effects / epidemiology*
Registries / statistics & numerical data
Risk Assessment
Sample Size
Triazines / adverse effects*
United States / epidemiology
Reg. No./Substance:
0/Anticonvulsants; 0/Triazines; U3H27498KS/lamotrigine
Comment In:
Neurology. 2006 Jan 10;66(1):153-4; author reply 153-4   [PMID:  16401876 ]
Neurology. 2005 Mar 22;64(6):938-9   [PMID:  15781803 ]
Epilepsy Curr. 2005 Nov-Dec;5(6):212-6   [PMID:  16372053 ]

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