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

On September 30, 2004, after more than 80 million patients had taken rofecoxib and annual sales had topped $2.5 billion, the company withdrew the drug because of an excess risk of myocardial infarctions and strokes.

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 . . .