| Bendectin and birth defects. II: Ecological analyses. | |
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MedLine Citation:
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PMID: 12769504 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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Jeffrey S Kutcher; Arnold Engle; Jacqueline Firth; Steven H Lamm |
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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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:
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Created Date: 2003-05-28 Completed Date: 2003-10-14 Revised Date: 2010-07-15 |
Medline Journal Info:
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Nlm Unique ID: 101155107 Medline TA: Birth Defects Res A Clin Mol Teratol Country: United States |
Other Details:
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Languages: eng Pagination: 88-97 Citation Subset: IM |
Affiliation:
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University of Michigan, Department of Neurology, Ann Arbor, Michigan 48109, USA. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Abnormalities, Drug-Induced
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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:
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0/Antiemetics; 0/Drug Combinations; 0/dicyclomine, doxylamine, pyridoxine drug combination; 469-21-6/Doxylamine; 65-23-6/Pyridoxine |
| Comments/Corrections | |
Comment In:
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Birth Defects Res A Clin Mol Teratol. 2003 Feb;67(2):79-87
[PMID:
12769503
]
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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