Document Detail


Bendectin and birth defects. II: Ecological analyses.
MedLine Citation:
PMID:  12769504     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Bendectin was the primary pharmaceutical treatment of nausea and vomiting of pregnancy (NVP) in the United States until the early 1980s. Its manufacture was then discontinued after public allegations that it was causing birth defects. Subsequently, meta-analyses of the many epidemiological cohort and case/control studies used to examine that hypothesis have demonstrated the absence of a detectable teratogenic effect. This study presents an ecological analysis of the same hypothesis that examines specific malformations. METHODS: Annual birth defect prevalence data for the 1970s to the 1990s have been obtained for specific birth defects from the Center for Disease Control's nationwide Birth Defect Monitoring Program. These data for the US have been compared graphically to the annual US Bendectin sales for the treatment of NVP. Data have also been obtained for annual US rates for hospitalization for NVP. The three data sets have been temporally compared in graphic analysis. RESULTS: The temporal trends in prevalence rates for specific birth defects examined from 1970 through 1992 did not show changes that reflected the cessation of Bendectin use over the 1980-84 period. Further, the NVP hospitalization rate doubled when Bendectin use ceased. CONCLUSIONS: The population results of the ecological analyses complement the person-specific results of the epidemiological analyses in finding no evidence of a teratogenic effect from the use of Bendectin.
Authors:
Jeffrey S Kutcher; Arnold Engle; Jacqueline Firth; Steven H Lamm
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Birth defects research. Part A, Clinical and molecular teratology     Volume:  67     ISSN:  1542-0752     ISO Abbreviation:  Birth Defects Res. Part A Clin. Mol. Teratol.     Publication Date:  2003 Feb 
Date Detail:
Created Date:  2003-05-28     Completed Date:  2003-10-14     Revised Date:  2010-07-15    
Medline Journal Info:
Nlm Unique ID:  101155107     Medline TA:  Birth Defects Res A Clin Mol Teratol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  88-97     Citation Subset:  IM    
Affiliation:
University of Michigan, Department of Neurology, Ann Arbor, Michigan 48109, USA.
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MeSH Terms
Descriptor/Qualifier:
Abnormalities, Drug-Induced / epidemiology,  etiology*
Abnormalities, Multiple / chemically induced,  epidemiology
Adult
Adverse Drug Reaction Reporting Systems
Animals
Antiemetics / adverse effects*,  pharmacokinetics,  therapeutic use
Doxylamine / adverse effects*,  pharmacokinetics,  therapeutic use
Drug Approval
Drug Combinations
Drug Utilization
Female
Fetus / drug effects
Hospitalization / statistics & numerical data
Humans
Incidence
Infant, Newborn
Liability, Legal
Nausea / drug therapy
Pregnancy
Pregnancy Complications / drug therapy
Pyridoxine / adverse effects*,  pharmacokinetics,  therapeutic use
Safety
United States
United States Food and Drug Administration
Vomiting / drug therapy
Chemical
Reg. No./Substance:
0/Antiemetics; 0/Drug Combinations; 0/dicyclomine, doxylamine, pyridoxine drug combination; 469-21-6/Doxylamine; 65-23-6/Pyridoxine
Comments/Corrections
Comment In:
Birth Defects Res A Clin Mol Teratol. 2003 Feb;67(2):79-87   [PMID:  12769503 ]

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


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