Lamotrigine use in pregnancy and risk of orofacial cleft and other congenital anomalies.

Détails

Ressource 1Télécharger: 27053714_BIB_96B58AD9F742.pdf (175.48 [Ko])
Etat: Public
Version: Final published version
ID Serval
serval:BIB_96B58AD9F742
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Institution
Titre
Lamotrigine use in pregnancy and risk of orofacial cleft and other congenital anomalies.
Périodique
Neurology
Auteur(s)
Dolk H., Wang H., Loane M., Morris J., Garne E., Addor M.C., Arriola L., Bakker M., Barisic I., Doray B., Gatt M., Kallen K., Khoshnood B., Klungsoyr K., Lahesmaa-Korpinen A.M., Latos-Bielenska A., Mejnartowicz J.P., Nelen V., Neville A., O'Mahony M., Pierini A., Rißmann A., Tucker D., Wellesley D., Wiesel A., de Jong-van den Berg L.T.
ISSN
1526-632X (Electronic)
ISSN-L
0028-3878
Statut éditorial
Publié
Date de publication
03/05/2016
Peer-reviewed
Oui
Volume
86
Numéro
18
Pages
1716-1725
Langue
anglais
Notes
Publication types: Journal Article
Publication Status: ppublish
Résumé
To test previous signals of a risk of orofacial cleft (OC) and clubfoot with exposure to the antiepileptic lamotrigine, and to investigate risk of other congenital anomalies (CA).
This was a population-based case-malformed control study based on 21 EUROCAT CA registries covering 10.1 million births (1995-2011), including births to 2005 in which the clubfoot signal was generated and a subsequent independent study population of 6.3 million births. A total of 226,806 babies with CA included livebirths, stillbirths, and terminations of pregnancy following prenatal diagnosis. First-trimester lamotrigine monotherapy exposure in OC cases and clubfoot cases was compared to other nonchromosomal CA (controls). Odds ratios (OR) were adjusted for registry. An exploratory analysis compared the proportion of each standard EUROCAT CA subgroup among all babies with nonchromosomal CA exposed to lamotrigine monotherapy with non-AED exposed pregnancies.
There were 147 lamotrigine monotherapy-exposed babies with nonchromosomal CA. For all OC, ORadj was 1.31 (95% confidence interval [CI] 0.73-2.33), isolated OC 1.45 (95% CI 0.80-2.63), isolated cleft palate 1.69 (95% CI 0.69-4.15). Overall ORadj for clubfoot was 1.83 (95% CI 1.01-3.31) and 1.43 (95% CI 0.66-3.08) in the independent study population. No other specific CA were significantly associated with lamotrigine monotherapy.
The risk of OC was not significantly raised and we estimate the excess risk of OC to be less than 1 in every 550 exposed babies. We have not found strong independent evidence of a risk of clubfoot subsequent to our original signal. Our study cannot assess the general malformation risk among lamotrigine-exposed pregnancies.

Mots-clé
Abnormalities, Drug-Induced/epidemiology, Adult, Anticonvulsants/adverse effects, Anticonvulsants/therapeutic use, Case-Control Studies, Cleft Lip/chemically induced, Cleft Lip/epidemiology, Cleft Palate/chemically induced, Cleft Palate/epidemiology, Epilepsy/drug therapy, Epilepsy/epidemiology, Europe/epidemiology, Female, Humans, Odds Ratio, Pregnancy, Pregnancy Complications/drug therapy, Pregnancy Complications/epidemiology, Pregnancy Trimester, First, Registries, Risk, Sensitivity and Specificity, Triazines/adverse effects, Triazines/therapeutic use
Pubmed
Open Access
Oui
Création de la notice
16/09/2016 19:38
Dernière modification de la notice
20/08/2019 15:58
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