Objective: To provide the fi rst update on drug safety profi les 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 1 st trimester (85.4 % ), especially for the fi rst 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 identifi ed drug exposures can help focus pharmacoepidemiologic efforts in drug-induced birth defects.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.