Better data needed from pregnancy registries

Gerald G. Briggs, Janine Polifka, Elizabeth Balken, Anick Berard, Stephen Braddock, Christina Chambers, Adrienne Einarson, Cecilia Lyons Gaffaney, Dee Quinn, Gideon Koren, Kenneth Jones, Steve Lamm, Richard Miller, Sara Riordan, Luther Robinson, Offie Soldin, Katherine Wisner, Lori Wolfe

Research output: Contribution to journalShort survey

16 Scopus citations

Abstract

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/m2) 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.

Original languageEnglish (US)
Pages (from-to)109-111
Number of pages3
JournalBirth Defects Research Part A - Clinical and Molecular Teratology
Volume85
Issue number2
DOIs
StatePublished - Feb 1 2009

Keywords

  • Exposure dose
  • Exposure timing
  • Pregnancy registries

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Embryology
  • Developmental Biology

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  • Cite this

    Briggs, G. G., Polifka, J., Balken, E., Berard, A., Braddock, S., Chambers, C., Einarson, A., Gaffaney, C. L., Quinn, D., Koren, G., Jones, K., Lamm, S., Miller, R., Riordan, S., Robinson, L., Soldin, O., Wisner, K., & Wolfe, L. (2009). Better data needed from pregnancy registries. Birth Defects Research Part A - Clinical and Molecular Teratology, 85(2), 109-111. https://doi.org/10.1002/bdra.20551