Document Detail


Better data needed from pregnancy registries.
MedLine Citation:
PMID:  19107958     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
Gerald G Briggs; Janine Polifka;
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Publication Detail:
Type:  Evaluation Studies; Journal Article    
Journal Detail:
Title:  Birth defects research. Part A, Clinical and molecular teratology     Volume:  85     ISSN:  1542-0760     ISO Abbreviation:  Birth Defects Res. Part A Clin. Mol. Teratol.     Publication Date:  2009 Feb 
Date Detail:
Created Date:  2009-02-12     Completed Date:  2009-04-14     Revised Date:  2013-05-06    
Medline Journal Info:
Nlm Unique ID:  101155107     Medline TA:  Birth Defects Res A Clin Mol Teratol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  109-11     Citation Subset:  IM    
Copyright Information:
(c) 2008 Wiley-Liss, Inc.
Affiliation:
Perinatal Support Service, MemorialCare Center for Women, Miller Children's Hospital, Long Beach Memorial Medical Center, Long Beach, CA 90806, USA. jbriggs@memorialcare.org
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MeSH Terms
Descriptor/Qualifier:
Abnormalities, Drug-Induced / epidemiology*
Congenital Abnormalities / epidemiology*,  etiology
Consensus
Dose-Response Relationship, Drug
Female
Humans
Pharmaceutical Preparations / adverse effects*
Pregnancy
Prenatal Exposure Delayed Effects / chemically induced,  epidemiology
Product Surveillance, Postmarketing / methods,  standards
Registries*
Risk Factors
Time Factors
Grant Support
ID/Acronym/Agency:
R01 AG033867/AG/NIA NIH HHS
Chemical
Reg. No./Substance:
0/Pharmaceutical Preparations
Investigator
Investigator/Affiliation:
Elizabeth Balken / ; Anick Berard / ; Stephen Braddock / ; Gerald Briggs / ; Christina Chambers / ; Adrienne Einarson / ; Cecilia Lyons Gaffaney / ; Mara Gaudette / ; Gideon Koren / ; Kenneth Jones / ; Steve Lamm / ; Richard Miller / ; Janine Polifka / ; Sara Riordan / ; Luther Robinson / ; Offie Soldin / ; Katherine Wisner / ; Lori Wolfe /

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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