COX-2 in play at the AHA and the FDA

The inhibition of cyclooxygenase (COX)-2 confers a small but absolute risk of cardiovascular events on patients taking nonsteroidal anti-inflammatory drugs (NSAIDs). This risk has been established by placebo-controlled trials of NSAIDs selective for COX-2; traditional NSAIDs seem to be heterogeneous with respect to cardiovascular risk. The American Heart Association (AHA) has proposed a ‘stepped-care’ approach to the use of NSAIDs in patients with cardiovascular disease, whereas the Food and Drug Administration (FDA) has failed to approve the COX-2-selective NSAID etoricoxib. In this article, these actions of the AHA and the FDA are interpreted in the light of current knowledge, prompting the formulation of scientific questions that might be addressed.