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.
Kuehn BM. FDA Panel: Keep COX-2 Drugs on Market. JAMA. 2005;293(13):1571-1572. doi:10.1001/jama.293.13.1571