Intrauterine exposure to carbamazepine and specific congenital malformations: systematic review and case-control study.

Détails

Ressource 1Télécharger: bmj.c6581.full.pdf (118.17 [Ko])
Etat: Public
Version: Final published version
ID Serval
serval:BIB_58A21DAFC31A
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Institution
Titre
Intrauterine exposure to carbamazepine and specific congenital malformations: systematic review and case-control study.
Périodique
Bmj
Auteur⸱e⸱s
Jentink J., Dolk H., Loane M.A., Morris J.K., Wellesley D., Garne E., de Jong-van den Berg L.
Collaborateur⸱rice⸱s
EUROCAT Antiepileptic Study Working Group
Contributeur⸱rice⸱s
Verellen-Dumoulin C., Nelen V., Barisic I., Garne E., Khoshnood B., Doray B., Poetzsch S., Wiesel A., O'Mahony M., Pierini A., Rivieri F., Gatt M., Bakker M., Melve K., Latos-Bielenska A., Mejnartowicz JP., Portillo I., Addor MC., Tucker D.
ISSN
1756-1833 (Electronic)
ISSN-L
0959-535X
Statut éditorial
Publié
Date de publication
2010
Volume
341
Pages
c6581
Langue
anglais
Notes
Publication types: Journal Article ; Research Support, Non-U.S. Gov't ; Review
Publication Status: epublish
Résumé
OBJECTIVE: To identify specific major congenital malformations associated with use of carbamazepine in the first trimester of pregnancy.
DESIGN: A review of all published cohort studies to identify key indications and a population based case-control study to test these indications.
SETTING: Review of PubMed, Web of Science, and Embase for papers about carbamazepine exposure in the first trimester of pregnancy and specific malformations, and the EUROCAT Antiepileptic Study Database, including data from 19 European population based congenital anomaly registries, 1995-2005.
PARTICIPANTS: The literature review covered eight cohort studies of 2680 pregnancies with carbamazepine monotherapy exposure, and the EUROCAT dataset included 98 075 registrations of malformations covering over 3.8 million births.
MAIN OUTCOME MEASURES: Overall prevalence for a major congenital malformation after exposure to carbamazepine monotherapy in the first trimester. Odds ratios for malformations with exposure to carbamazepine among cases (five types of malformation identified in the literature review) compared with two groups of controls: other non-chromosomal registrations of malformations and chromosomal syndromes.
RESULTS: The literature review yielded an overall prevalence for a major congenital malformation of 3.3% (95% confidence interval 2.7 to 4.2) after exposure to carbamazepine monotherapy in the first trimester. In 131 registrations of malformations, the fetus had been exposed to carbamazepine monotherapy. Spina bifida was the only specific major congenital malformation significantly associated with exposure to carbamazepine monotherapy (odds ratio 2.6 (95% confidence interval 1.2 to 5.3) compared with no antiepileptic drug), but the risk was smaller for carbamazepine than for valproic acid (0.2, 0.1 to 0.6). There was no evidence for an association with total anomalous pulmonary venous return (no cases with carbamazepine exposure), cleft lip (with or without palate) (0.2, 0.0 to 1.3), diaphragmatic hernia (0.9, 0.1 to 6.6), or hypospadias (0.7, 0.3 to 1.6) compared with no exposure to antiepileptic drugs. Further exploratory analysis suggested a higher risk of single ventricle and atrioventricular septal defect.
CONCLUSION: Carbamazepine teratogenicity is relatively specific to spina bifida, though the risk is less than with valproic acid. Despite the large dataset, there was not enough power to detect moderate risks for some rare major congenital malformations.
Mots-clé
Abnormalities, Drug-Induced/epidemiology, Abnormalities, Drug-Induced/etiology, Anticonvulsants/adverse effects, Carbamazepine/adverse effects, Case-Control Studies, Epilepsy/drug therapy, Epilepsy/epidemiology, Europe/epidemiology, Female, Humans, Infant, Newborn, Pregnancy, Pregnancy Complications/drug therapy, Pregnancy Complications/epidemiology, Pregnancy Trimester, First, Prenatal Exposure Delayed Effects/epidemiology, Prenatal Exposure Delayed Effects/etiology, Prevalence, Risk Factors
Pubmed
Web of science
Création de la notice
21/03/2011 11:59
Dernière modification de la notice
20/08/2019 14:12
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