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

Details

Serval ID
serval:BIB_57D38150B16E
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Pharmacovigilance in pregnancy: adverse drug reactions associated with fetal disorders.
Journal
Journal of perinatal medicine
Author(s)
Wettach C., Thomann J., Lambrigger-Steiner C., Buclin T., Desmeules J., von Mandach U.
ISSN
1619-3997 (Electronic)
ISSN-L
0300-5577
Publication state
Published
Issued date
05/2013
Peer-reviewed
Oui
Volume
41
Number
3
Pages
301-307
Language
english
Notes
Publication types: Journal Article ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Abstract
To provide the first update on drug safety profiles and adverse drug reactions (ADRs) associated with fetal disorders from the Swiss national ADR database.
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.
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.
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.
Keywords
Abnormalities, Drug-Induced/epidemiology, Chromosome Aberrations/chemically induced, Databases, Factual/statistics & numerical data, Drug-Related Side Effects and Adverse Reactions/epidemiology, Female, Fetal Diseases/chemically induced, Fetal Diseases/epidemiology, Fetal Growth Retardation/chemically induced, Fetal Growth Retardation/epidemiology, Humans, Pharmacovigilance, Pregnancy, Pregnancy Complications/drug therapy, Retrospective Studies, Switzerland/epidemiology
Pubmed
Web of science
Create date
15/02/2013 11:43
Last modification date
19/02/2021 7:26
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