Chief Resident, Internal Medicine, Huntington Memorial Hospital

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,"
September 30, 2004

The attached 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. An error has been identified on page 6 of the report. The National Disease and Therapeutic Index collects detailed information from a representative panel of 3,500 physicians, not 2,000 physicians.