Raising the Safety Bar — The FDA's Coxib Meeting

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Abstract
After sitting through three days of testimony and debate last month, a panel of experts advising the Food and Drug Administration (FDA) rendered an ambivalent verdict on the future of the cyclooxygenase-2 (COX-2) inhibitors. On the one hand, the 32 members of the advisory committee agreed that these drugs for pain and arthritis pose serious hazards. They voted unanimously that the available evidence on the three approved “coxibs” — rofecoxib, celecoxib, and valdecoxib — supports the conclusion that each of the drugs significantly increases users' risk of cardiovascular events, including heart attacks and strokes. Nonetheless, the committee also voted, by . . .