Pregnancy outcome following maternal exposure to pregabalin may call for concern.

Détails

ID Serval
serval:BIB_BAB64140AB78
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Titre
Pregnancy outcome following maternal exposure to pregabalin may call for concern.
Périodique
Neurology
Auteur(s)
Winterfeld U., Merlob P., Baud D., Rousson V., Panchaud A., Rothuizen L.E., Bernard N., Vial T., Yates L.M., Pistelli A., Ellfolk M., Eleftheriou G., de Vries L.C., Jonville-Bera A.P., Kadioglu M., Biollaz J., Buclin T.
ISSN
1526-632X (Electronic)
ISSN-L
0028-3878
Statut éditorial
Publié
Date de publication
14/06/2016
Peer-reviewed
Oui
Volume
86
Numéro
24
Pages
2251-2257
Langue
anglais
Notes
Publication types: Journal Article ; Multicenter Study ; Observational Study
Publication Status: ppublish
Résumé
To investigate pregnancy outcomes following maternal use of pregabalin.
This multicenter, observational prospective cohort study compared pregnancy outcomes in women exposed to pregabalin with those of matched controls (not exposed to any medications known to be teratogenic or to any antiepileptic drugs). Teratology Information Services systematically collected data between 2004 and 2013.
Data were collected from 164 exposed pregnancies and 656 controls. A significantly higher major birth defect rate in the pregabalin group was observed after exclusion of chromosomal aberration syndromes, and when cases with exposure during first trimester of pregnancy were analyzed separately (7/116 [6.0%] vs 12/580 [2.1%]; odds ratio 3.0, 95% confidence interval 1.2-7.9, p = 0.03). The rate of live births was lower in the pregabalin group (71.9% vs 85.2%, p < 0.001), primarily due to a higher rate of both elective (9.8% vs 5.0%, p = 0.02) and medically indicated (5.5% vs 1.8%, p = 0.008) pregnancy terminations. In the Cox proportional cause specific hazards model, pregabalin exposure was not associated with a significantly higher risk of spontaneous abortion.
This study demonstrated a signal for increased risk of major birth defects after first trimester exposure to pregabalin. However, several limitations such as the small sample size, differences across groups in maternal conditions, and concomitant medication exposure exclude definitive conclusions, so these results call for confirmation through independent studies.

Mots-clé
Abnormalities, Drug-Induced/epidemiology, Adult, Central Nervous System Agents/adverse effects, Central Nervous System Agents/therapeutic use, Europe, Female, Humans, Incidence, Pharmacovigilance, Pregabalin/adverse effects, Pregabalin/therapeutic use, Pregnancy, Pregnancy Outcome/epidemiology, Pregnancy Trimester, First/drug effects, Proportional Hazards Models, Prospective Studies, Risk
Pubmed
Création de la notice
14/06/2016 14:33
Dernière modification de la notice
20/08/2019 15:28
Données d'usage