Measuring drug effectiveness by default: the case of Bendectin

Area of Science:

• Obstetrics and Gynecology
• Pharmacology
• Public Health

Background:

• Bendectin was widely used to treat nausea and vomiting during pregnancy (NVP).
• Despite extensive scientific evidence supporting its safety, Bendectin was voluntarily withdrawn from the market in 1983 due to litigation.
• Approximately 10-25% of pregnancies were exposed to Bendectin during its market presence.

Purpose of the Study:

• To evaluate the public health and economic consequences of Bendectin's market withdrawal.
• To assess the impact on hospitalization rates for NVP and associated costs.

Main Methods:

• Analysis of hospitalization data for excessive vomiting in pregnancy before and after 1983.
• Estimation of excess hospital costs in Canada and the United States.

Main Results:

• Hospital admissions for NVP increased significantly post-withdrawal: 37% in 1983 and 50% in 1984 compared to 1980-82 averages.
• Estimated excess hospital costs were $16 million (Canada) and $73 million (U.S.) between 1983-1987.
• No observed decrease in congenital malformation rates was associated with the drug's removal.

Conclusions:

• The withdrawal of Bendectin resulted in substantial increases in healthcare utilization and costs related to NVP.
• The economic and social burdens associated with increased NVP hospitalizations were not offset by any reduction in birth defects.
• This case highlights the potential adverse consequences of removing a safe and effective medication from the market.