Document Detail


Major malformations in infants exposed to antiepileptic drugs in utero, with emphasis on carbamazepine and valproic acid: a nation-wide, population-based register study.
MedLine Citation:
PMID:  15046269     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
AIM: Antiepileptic drugs (AEDs) are known teratogens. Some specificity between different AEDs has been noted in the literature. The aim was to compare the teratogenic effect of valproic acid (VPA) and carbamazepine (CBZ) in monotherapy. METHODS: Infants exposed to AEDs (n = 1398) in early pregnancy were identified from the Swedish Medical Birth Registry. The number of infants with congenital malformations and exposed to AED was compared with the expected number estimated from all infants born (n = 582656). RESULTS: 90% (1256) of the AED exposed children were exposed to AEDs in monotherapy, 56% were exposed to CBZ and 21% to VPA. The odds ratio (OR) for having a malformation in the AED exposed group was 1.86 [95% confidence interval (95% CI) 1.42-2.44]. Exposure to VPA in monotherapy compared with CBZ in monotherapy gave OR = 2.51 (95% CI 1.43-4.68) for a neonatal diagnosis of malformations. However, there is no information available on the number of therapeutic abortions, or the different types of epilepsy or drug dosage in the two treatment groups. CONCLUSION: There was a small increase in the risk of having a major malformation after exposure to AEDs in monotherapy. Exposure to VPA seems to carry a higher risk than exposure to CBZ.
Authors:
K Wide; B Winbladh; B Källén
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Publication Detail:
Type:  Comparative Study; Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Acta paediatrica (Oslo, Norway : 1992)     Volume:  93     ISSN:  0803-5253     ISO Abbreviation:  Acta Paediatr.     Publication Date:  2004 Feb 
Date Detail:
Created Date:  2004-03-29     Completed Date:  2004-06-14     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  9205968     Medline TA:  Acta Paediatr     Country:  Norway    
Other Details:
Languages:  eng     Pagination:  174-6     Citation Subset:  IM    
Affiliation:
Department of Clinical Sciences, Division of Pediatrics, Karolinska Insitutet, Huddinge University Hospital, Stockholm, Sweden. katarina.wide@klinvet.ki.se
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MeSH Terms
Descriptor/Qualifier:
Abnormalities, Multiple / chemically induced*,  diagnosis*,  epidemiology
Adult
Anticonvulsants / adverse effects*
Carbamazepine / adverse effects*
Epilepsy / drug therapy*
Female
Fetal Diseases / chemically induced*
Humans
Infant, Newborn
Population Surveillance
Pregnancy
Pregnancy Complications
Pregnancy Outcome
Prenatal Exposure Delayed Effects*
Registries*
Valproic Acid / adverse effects*
Chemical
Reg. No./Substance:
0/Anticonvulsants; 298-46-4/Carbamazepine; 99-66-1/Valproic Acid

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


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