UNIGE document Scientific Article
previous document  unige:26887  next document
add to browser collection
Title

Pharmacovigilance in pregnancy: adverse drug reactions associated with fetal disorders

Authors
Wettach, Carmen
Thomann, Janine
Lambrigger-Steiner, Claudia
von Mandach, Ursula
Published in Journal of Perinatal Medicine. 2012, vol. 0, no. 0, p. 1-7
Abstract 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.
Identifiers
PMID: 23027583
Full text
Article (Published version) (708 Kb) - public document Free access
Structures
Research group Groupe Desmeules Jules (pharmacologie/toxicologie) (567)
Citation
(ISO format)
WETTACH, Carmen et al. Pharmacovigilance in pregnancy: adverse drug reactions associated with fetal disorders. In: Journal of Perinatal Medicine, 2012, p. 1-7. https://archive-ouverte.unige.ch/unige:26887

241 hits

798 downloads

Update

Deposited on : 2013-03-21

Export document
Format :
Citation style :