Bendectin and birth defects. II: Ecological analyses

Birth Defects Res A Clin Mol Teratol. 2003 Feb;67(2):88-97. doi: 10.1002/bdra.10034.

Abstract

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.

MeSH terms

  • Abnormalities, Drug-Induced / epidemiology
  • Abnormalities, Drug-Induced / etiology*
  • Abnormalities, Multiple / chemically induced
  • Abnormalities, Multiple / epidemiology
  • Adult
  • Adverse Drug Reaction Reporting Systems
  • Animals
  • Antiemetics / adverse effects*
  • Antiemetics / pharmacokinetics
  • Antiemetics / therapeutic use
  • Dicyclomine
  • Doxylamine / adverse effects*
  • Doxylamine / pharmacokinetics
  • Doxylamine / 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*
  • Pyridoxine / pharmacokinetics
  • Pyridoxine / therapeutic use
  • Safety
  • United States
  • United States Food and Drug Administration
  • Vomiting / drug therapy

Substances

  • Antiemetics
  • Drug Combinations
  • dicyclomine, doxylamine, pyridoxine drug combination
  • Dicyclomine
  • Doxylamine
  • Pyridoxine