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

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 m...

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Bibliographic Details
Published inThe New England journal of medicine Vol. 351; no. 17; pp. 1707 - 1709
Main Author Topol, Eric J
Format Journal Article
LanguageEnglish
Published United States Massachusetts Medical Society 21.10.2004
Subjects
Adverse Drug Reaction Reporting Systems
Advertising as Topic
Arthritis
Arthritis, Rheumatoid - drug therapy
Cardiovascular disease
Clinical Trials as Topic - history
Cyclooxygenase Inhibitors - adverse effects
Cyclooxygenase Inhibitors - history
Drug Approval - history
Drug Industry - history
Drug Industry - legislation & jurisprudence
Heart attacks
History, 20th Century
History, 21st Century
Humans
Lactones - adverse effects
Lactones - history
Meetings
Myocardial Infarction - chemically induced
Risk
Stroke - chemically induced
Sulfones
United States
United States Food and Drug Administration - history
United States
United States > US
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Summary: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 . . .
ISSN:0028-4793
1533-4406
DOI:10.1056/NEJMp048286