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Black Box for COX-2 Labels, Caution Urged for All NSAIDs

Bridget M. Kuehn

JAMA. 2005;293:1571-1572.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

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.

Alastair Wood, MD, who chaired the joint panel of FDA arthritis and drug safety experts charged with assessing the risks of COX-2 inhibitors, confers during the proceedings with Kimberly Littleton Topper, . . . [Full Text of this Article]

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THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

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ABSTRACT | FULL TEXT