Pharmacovigilance in pregnancy: adverse drug reactions associated with fetal disorders

J Perinat Med. 2013 May;41(3):301-7. doi: 10.1515/jpm-2012-0091.


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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Abnormalities, Drug-Induced / epidemiology
  • Chromosome Aberrations / chemically induced
  • Databases, Factual / statistics & numerical data
  • Drug-Related Side Effects and Adverse Reactions* / epidemiology
  • Female
  • Fetal Diseases / chemically induced*
  • Fetal Diseases / epidemiology
  • Fetal Growth Retardation / chemically induced
  • Fetal Growth Retardation / epidemiology
  • Humans
  • Pharmacovigilance
  • Pregnancy
  • Pregnancy Complications / drug therapy*
  • Retrospective Studies
  • Switzerland / epidemiology