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The Food and Drug Administration has obtained and is evaluating new and sometimes conflicting scientific data on adverse events associated with the use of several non-steroidal anti-inflammatory drugs (NSAIDs) and COX-2 inhibitors. New data indicates an increased risk of major fatal and non-fatal heart attacks in clinical trial participants taking these drugs. At this time, the National Institutes of Health has suspended clinical trials involving the use of non-steroidal anti-inflammatory drugs (NSAIDs), such as naproxen or Aleve™, and the COX-2 inhibitor celecoxib (Celebrex™). FDA advises patients who are currently taking over-the-counter naproxen products to carefully follow the instructions on the label. Additional resources are listed below.

• FDA Issues Public Health Advisory Recommending Limited Use of Cox-2 Inhibitors (12/23/04)

• Use of Non-Steroidal Anti-Inflammatory Drugs Suspended in Large Alzheimer's Disease Prevention Trial (12/20/04)

• NIH Halts Use of COX-2 Inhibitor in Large Cancer Prevention Trial (12/17/04)

BEXTRA

• Center for Drug Evaluation and Research - Bextra (valdecoxib) Information Resources Page

CELEBREX

• FDA Statement on Celebrex DTC Promotion (12/20/04)

• FDA Statement on the Halting of a Clinical Trial of the COX-2 Inhibitor Celebrex (12/17/04)

• Center for Drug Evaluation and Research - Celebrex (celecoxib) Information Resources Page

NAPROXEN

• FDA Statement on Naproxen

Non-Steroidal Anti-Inflammatory Products (NSAIDS)

• Center for Drug Evaluation and Research - NSAIDs Information Resource Page

VIOXX

• FDA Issues Public Health Advisory on Vioxx as its Manufacturer Voluntarily Withdraws the Product (9/30/04)

• Center for Food Safety and Applied Nutrition – Vioxx Information Resources Page (9/30/04)