[Skip to Content]
[Skip to Content Landing]
Medical News and Perspectives
April 6, 2005

FDA Panel: Keep COX-2 Drugs on Market

JAMA. 2005;293(13):1571-1572. doi:10.1001/jama.293.13.1571

With questions remaining about the safety of nonsteroidal anti-inflammatory drugs (NSAIDs), a Food and Drug Administration (FDA) advisory panel recommended that the agency allow the marketing of NSAIDs that selectively inhibit cyclooxygenase 2 (COX-2) but urged greater caution with the use of all NSAIDs. At press time, the FDA had yet to make a decision about the recommendations.

Far from providing the clear-cut answers many had hoped for, the panel’s analysis of clinical data painted a nuanced picture of the risks and benefits of NSAIDs. The panel found important differences between rofecoxib, celecoxib, and valdecoxib—the three COX-2 inhibitors at the center of the debate over NSAID safety, but also noted that all three pose serious risks.

First Page Preview View Large
First page PDF preview
First page PDF preview