No abstract

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.