Measuring drug effectiveness by default: the case of Bendectin

Can J Public Health. Jan-Feb 1995;86(1):66-70.

Abstract

In 1983, Bendectin was voluntarily removed from the market by Merrell Dow Pharmaceuticals Inc. because of the many product liability suits pending. Earlier, 10 to 25% of pregnancies were exposed to Bendectin and over the years the drug was used in as many as 33 million pregnancies. The scientific evidence available pointed to the safety of Bendectin. This article considers some of the effects of the withdrawal of the drug. In 1983, hospital admissions for excessive vomiting in pregnancy per thousand live births rose by 37% over 1980-82 ratios and by 50% in 1984. In the United States, hospitalization rose by similar amounts. A rough estimate of excess hospital costs over the years 1983-87 is $16 million for Canada and $73 million for the U.S. Such estimates do not take into consideration other costs, such as extra physician visits, increased absenteeism from work, and the effect on quality of life of the pregnant woman and her family. No decrease in rates of congenital malformations could be shown to offset this increased cost to society.

MeSH terms

  • Abnormalities, Drug-Induced / epidemiology
  • Abnormalities, Drug-Induced / etiology
  • Antiemetics / adverse effects*
  • Antiemetics / supply & distribution
  • Canada / epidemiology
  • Dicyclomine
  • Doxylamine / adverse effects*
  • Doxylamine / supply & distribution
  • Drug Combinations
  • Drug and Narcotic Control*
  • Female
  • Health Care Costs / trends
  • Hospitalization / economics
  • Hospitalization / statistics & numerical data
  • Hospitalization / trends
  • Humans
  • Pregnancy
  • Pregnancy Complications / epidemiology
  • Product Surveillance, Postmarketing / methods*
  • Pyridoxine / adverse effects*
  • Pyridoxine / supply & distribution
  • Teratogens*
  • United States / epidemiology
  • Vomiting / epidemiology

Substances

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