FDA Panel Urges Caution on Many Anti-Inflammatory Drugs

GAITHERSBURG, MARYLAND—At a 3-day meeting last week to hash out how a class of painkillers might trigger heart attacks and strokes, new puzzles emerged, even as two U.S. Food and Drug Administration (FDA) advisory committees agreed that use of the drugs, known as COX-2 inhibitors, be allowed but sharply curtailed. Wrestling with questions that affect millions of patients and billions of dollars in drug company revenue, the committees—on arthritis drugs and drug safety—voted in favor of keeping Celebrex, Bextra, and even Vioxx on the market but adding stringent warnings to them and possibly other nonsteroidal anti-inflammatory drugs (NSAIDs). Steven Galson, acting head of FDA's Center for Drug Evaluation and Research, said in advance that FDA would act rapidly on the panel's recommendations, likely within a few weeks.