Pharmacovigilance in pregnancy: adverse drug reactions associated with fetal disorders.

Détails

ID Serval
serval:BIB_8250832D5EBE
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Titre
Pharmacovigilance in pregnancy: adverse drug reactions associated with fetal disorders.
Périodique
Journal of Perinatal Medicine
Auteur(s)
Wettach C., Thomann J., Lambrigger-Steiner C., Buclin T., Desmeules J., von Mandach U.
ISSN
1619-3997 (Electronic)
ISSN-L
0300-5577
Statut éditorial
Publié
Date de publication
2012
Peer-reviewed
Oui
Volume
41
Numéro
3
Pages
301-307
Langue
anglais
Notes
Publication types: JOURNAL ARTICLE
Résumé
Abstract Objective: To provide the first update on drug safety profiles and adverse drug reactions (ADRs) associated with fetal disorders from the Swiss national ADR database. Methods: We conducted a retrospective study using data from 202 pharmacovigilance reports on drug-associated fetal disorders from the Swiss national ADR database from 1990 to 2009. Evaluated aspects included administrative information on the report, drug exposure, and disorders. Results: The ADR reporting frequency on the topic of fetal disorders has increased during the last 20 years, from only 1 report in 1991 to a maximum of 31 reports in 2008. Nervous system drugs were the most frequently reported drug group (40.2%) above all antidepressants and antiepileptics. The highest level of overall drug intake could be observed for the 1st trimester (85.4%), especially for the first 6 weeks of pregnancy. The most frequently reported types of fetal disorders were malformations (68.8%), especially those of the musculoskeletal and circulatory systems. A positive association was discovered between antiepileptics and malformations in general and in particular of the circulatory system and the eye, ear, face, and neck. Conclusions: The results suggest that the nervous system drug group bears an especially high risk for malformations. The most commonly identified drug exposures can help focus pharmacoepidemiologic efforts in drug-induced birth defects.
Pubmed
Web of science
Création de la notice
15/03/2013 12:27
Dernière modification de la notice
03/03/2018 18:50
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