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 . . .
Keywords
MedicineRofecoxibDrug approvalPublic healthDrug labelingIntensive care medicinePharmacologyFamily medicineDrugPathology
Affiliated Institutions
Related Publications
Risk Adjustment in Outcome Assessment: the Charlson Comorbidity Index
Abstract To measure the burden of comorbid diseases using the MED-ECHO database (Quebec), the so-called Charlson index was adapted to International Classification of Disease (IC...
Publication Info
- Year
- 2004
- Type
- article
- Volume
- 351
- Issue
- 17
- Pages
- 1707-1709
- Citations
- 587
- Access
- Closed
External Links
Social Impact
Altmetric
PlumX Metrics
Social media, news, blog, policy document mentions
Citation Metrics
587
OpenAlex
Cite This
Eric J. Topol
(2004).
Failing the Public Health — Rofecoxib, Merck, and the FDA.
New England Journal of Medicine
, 351
(17)
, 1707-1709.
https://doi.org/10.1056/nejmp048286
Identifiers
- DOI
- 10.1056/nejmp048286