Vioxx Side Effects Report

Released September 30, 2004

Memorandum from David J. Graham, MD, MPH, Associate Director for Science, Office of Drug Safety to Paul Seligman, MD, MPH, Acting Director, Office of Drug Safety entitled, "Risk of Acute Myocardial Infarction and Sudden Cardiac Death in Patients Treated with COX-2 Selective and Non-Selective NSAIDs."

Conclusion
Rofecoxib increases the risk of serious coronary heart disease defined as acute myocardial infarction and sudden cardiac death. High-dose rofecoxib increased risk by 3.7-fold and standard-dose rofecoxib increased risk by 1.5-fold compared to celecoxib use. The observation of an increased risk was first noted with the VIGOR trial, where a 5-fold difference in risk was found between high-dose rofecoxib and naproxen. The manufacturer attributed this difference to a never before recognized protective effect of naproxen. To explain a 5-fold difference, naproxen would have had to be one of the most potent and effective cardio-protectants known. Three cohort studies and the present nested case-control study found no evidence of cardio-protection with naproxen. The three case-control studies that reported a protective effect were misleading. When analyzed in a manner comparable to the present study, no protective effect is shown.

Source: The report was prepared for internal FDA use by an FDA staff person who was the principal FDA investigator on a study performed to investigate the cardiovascular risk of the COX-2 selective NSAIDs, rofecoxib and celecoxib, and a variety of non-selective, traditional NSAIDs. This report may differ from any subsequent manuscript publication of the study results. As of the date of posting (November 2), the report has not been fully evaluated by the FDA and may not reflect the official views of the agency. However, in light of the recent market withdrawal of Vioxx, FDA has decided to publicly release the document at this time.

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