Document Detail

Increased frequency of isolated cleft palate in infants exposed to lamotrigine during pregnancy.
MedLine Citation:
PMID:  18448870     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Pregnancy registries for women taking anticonvulsant drugs have been developed to determine more efficiently the fetal risks of each drug. A total of 722 drug-exposed pregnancies are needed to identify a sevenfold increase in the rate of occurrence of a specific abnormality, such as spina bifida, with a frequency of 1 in 1,000.
METHODS: The infants with major malformations born to the 791 women who had taken lamotrigine as monotherapy and had enrolled in the North American AED Pregnancy Registry were identified. Medical records were obtained from the affected infants' doctors. A total of 107 of the 791 infants or pregnancies were excluded.
RESULTS: A total of 16 (2.3%) of 684 infants exposed to lamotrigine had major malformations that were identified at birth. Five infants (7.3/1,000) had oral clefts: isolated cleft palate (3), isolated cleft lip (1), and cleft lip and palate (1). The rate among the lamotrigine-exposed infants showed a 10.4-fold increase (95% CI: 4.3-24.9) in comparison to 206,224 unexposed infants surveyed at birth at Brigham and Women's Hospital in Boston, where the prevalence of isolated oral clefts was 0.7/1,000. A comparison was made also to 1,623 infants exposed to lamotrigine, as monotherapy, who had enrolled in five other registries. There were four infants with oral clefts: prevalence 2.5/1,000 (RR: 3.8, 95% CI: 1.4-10.0).
CONCLUSIONS: The infant exposed in the first trimester of pregnancy to the anticonvulsant drug lamotrigine has an increased risk to have an isolated cleft palate or cleft lip deformity.
L B Holmes; E J Baldwin; C R Smith; E Habecker; L Glassman; S L Wong; D F Wyszynski
Publication Detail:
Type:  Journal Article     Date:  2008-04-30
Journal Detail:
Title:  Neurology     Volume:  70     ISSN:  1526-632X     ISO Abbreviation:  Neurology     Publication Date:  2008 May 
Date Detail:
Created Date:  2008-05-28     Completed Date:  2008-07-01     Revised Date:  2013-08-21    
Medline Journal Info:
Nlm Unique ID:  0401060     Medline TA:  Neurology     Country:  United States    
Other Details:
Languages:  eng     Pagination:  2152-8     Citation Subset:  AIM; IM    
Genetics Unit, MassGeneral Hospital for Children, CPZS-504, 175 Cambridge Street, Boston, MA 02114, USA.
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MeSH Terms
Abnormalities, Drug-Induced / etiology*
Anticonvulsants / adverse effects*
Cleft Palate / chemically induced*,  epidemiology*
Epilepsy / drug therapy
Infant, Newborn
Prenatal Exposure Delayed Effects*
Retrospective Studies
Triazines / adverse effects*
Reg. No./Substance:
0/Anticonvulsants; 0/Triazines; U3H27498KS/lamotrigine
Comment In:
Neurology. 2009 Mar 24;72(12):1108; author reply 1108-9   [PMID:  19307550 ]
Erratum In:
Neurology. 2009 Apr 21;72(16):1449

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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