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J Perinat Med. 2013 May;41(3):301-7.

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

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1
Department of Obstetrics and Gynecology, Perinatal Pharmacology, Zurich University Hospital, Zurich, Switzerland.

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.

PMID:
23027583
DOI:
10.1515/jpm-2012-0091
[Indexed for MEDLINE]
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