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Pharmacovigilance in pregnancy: adverse drug reactions associated with fetal disorders

Wettach, Carmen ; Thomann, Janine ; Lambrigger-Steiner, Claudia ; Buclin, Thierry ; Desmeules, Jules ; von Mandach, Ursula

In: Journal of Perinatal Medicine, 2013, vol. 41, no. 3, p. 301-307

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    Title
    • Pharmacovigilance in pregnancy: adverse drug reactions associated with fetal disorders
    Author
    • Wettach, Carmen. Department of Obstetrics and Gynecology, Perinatal Pharmacology, Zurich University Hospital, Zurich, Switzerland
    • Thomann, Janine. Department of Obstetrics and Gynecology, Perinatal Pharmacology, Zurich University Hospital, Zurich, Switzerland
    • Lambrigger-Steiner, Claudia. Department of Obstetrics and Gynecology, Perinatal Pharmacology, Zurich University Hospital, Zurich, Switzerland
    • Buclin, Thierry. Division of Clinical Pharmacology and Toxicology, Department of Internal Medicine, University Hospital Lausanne, Switzerland
    • Desmeules, Jules. Division of Clinical Pharmacology and Toxicology, Department of Internal Medicine, Geneva University Hospitals, Geneva, Switzerland
    • von Mandach, Ursula. Department of Obstetrics and Gynecology, Perinatal Pharmacology, Zurich University Hospital, Zurich, Switzerland
    Document Type
    • Postprint
    Language
    • English
    Published in
    • Journal of Perinatal Medicine, 2013, vol. 41, no. 3, p. 301-307. Walter de Gruyter
    Other Version
    OAI-PMH Identifier
    • oai:doc.rero.ch:304365
    Summary
    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