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Medical News & 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.