FDA advisers warn: COX 2 inhibitors increase risk of heart attack and stroke

Abstract

After three days of deliberation an advisory panel to the US Food and Drug Administration decided that the widely used cyclo-oxygenase-2 (COX 2) inhibitors rofecoxib (Vioxx), celecoxib (Celebrex), and valdecoxib (Bextra) all carry serious risks of heart attack and stroke and recommended that the FDA demand that the drugs carry “black box” warnings. But the panel did not recommend that the drugs be withdrawn from the market. The panel was convened after Merck voluntarily withdrew rofecoxib (Vioxx) from the market on 30 September ( BMJ 2004;329: 816, 9 Oct) when it was found that the drug doubles the risk of heart attacks and strokes in patients who take it for 18 months or longer. US media coverage of the panel's findings has been criticised by Dr Alastair Wood, the panel's chairman and associate dean at Vanderbilt University School of Medicine, Nashville. He said that the coverage was distorted because it focused on the fact that the panel had not recommended the drugs' withdrawal rather than on its finding of an increased risk of heart attack and stroke. He said, “The general outcome [of the hearings] was greatly overrated in the US press. Two drugs were recommended for removal from the market by almost 50% of the …