Better data needed from pregnancy registries

Birth Defects Res A Clin Mol Teratol. 2009 Feb;85(2):109-11. doi: 10.1002/bdra.20551.


This article is a consensus position statement from the Research Committee of the Organization of Teratology Information Specialists (OTIS). The Committee believes that more specific information on the timing and dose of drug exposures from pregnancy birth defect registries sponsored by pharmaceutical companies (herein called pregnancy registries) would improve the estimation of risk for developmental toxicity (i.e., growth alteration, structural anomalies, functional/neurobehavioral deficits, or death). Specifically, the Committee believes that the exposure timing should be stated in gestational weeks and days rather than simply weeks. In addition, the Committee believes that the exposure dose should be stated in patient-specific terms, such as body weight (mg/kg) or body surface area (mg/m(2)) rather than simply dose strength. Although the focus of this position is pregnancy registries, it also is applicable to any source of medication-induced embryo-fetal toxicity.

Publication types

  • Evaluation Study

MeSH terms

  • Abnormalities, Drug-Induced / epidemiology*
  • Congenital Abnormalities / epidemiology*
  • Congenital Abnormalities / etiology
  • Consensus
  • Dose-Response Relationship, Drug
  • Drug-Related Side Effects and Adverse Reactions*
  • Female
  • Humans
  • Pregnancy
  • Prenatal Exposure Delayed Effects / chemically induced
  • Prenatal Exposure Delayed Effects / epidemiology
  • Product Surveillance, Postmarketing / methods
  • Product Surveillance, Postmarketing / standards
  • Registries*
  • Risk Factors
  • Time Factors