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Eric J. Topol, MD

JAMA. 2005;293:366-368. Published online December 28, 2004 (doi:10.1001/jama.293.3.366)

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

Physicians, patients, and the general public are confronted with an acute confusional state regarding the cardiovascular safety of medicines for arthritis. Since September 30, 2004, the day that rofecoxib was precipitously withdrawn, there has hardly been a day without significant news on the general topic of cyclooxygenase 2 (COX-2) inhibitors. On December 9, 2004, the US Food and Drug Administration (FDA) issued a black box warning for valdecoxib for life-threatening skin reactions and cardiovascular risk.¹ Just over a week later, on December 17, 2004, the National Cancer Institute announced the premature cessation of a trial of celecoxib known as Adenoma Prevention with Celecoxib (APC) due to a significant excess of cardiovascular death, myocardial infarction (MI), and stroke.²

The principal cardiovascular event data for APC are summarized in the Figure. This was a trial of 2026 patients, with randomization to 1 of 3 groups: placebo; celecoxib, . . . [Full Text of this Article]

Author Affiliations: Department of Cardiovascular Medicine, Cleveland Clinic Foundation; Office of the Provost, Cleveland Clinic Lerner College of Medicine; Case Western Reserve University, Cleveland, Ohio.

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