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This analysis aims to examine the approval and subsequent withdrawal of rofecoxib, focusing on public health implications.

October 7, 2004Open Access

Failing the Public Health — Rofecoxib, Merck, and the FDA

Key Points

This analysis aims to examine the approval and subsequent withdrawal of rofecoxib, focusing on public health implications.
Chronological review of events from approval to withdrawal of rofecoxib.
Analysis of communication and decision-making processes within Merck and the FDA.
Assessment of public health consequences stemming from the drug's usage.
Rofecoxib was withdrawn after over 80 million prescriptions due to increased risks of myocardial infarctions and strokes.
The withdrawal marks the largest prescription-drug withdrawal in history.
Warnings about rofecoxib's risks were largely ignored by both Merck and the FDA.

Abstract

On May 21, 1999, Merck was granted approval by the Food and Drug Administration (FDA) to market rofecoxib (Vioxx). On September 30, 2004, after more than 80 million patients had taken this medicine and annual sales had topped 2. 5 billion, the company withdrew the drug because of an excess risk of myocardial infarctions and strokes. This represents the largest prescription-drug withdrawal in history, but had the many warning signs along the way been heeded, such a debacle could have been prevented. Neither of the two major forces in this five-and-a-half-year affair — neither Merck nor the FDA — fulfilled its. . .

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