Bextra and the FDA

FDA announced in December of 2004 that it is requiring evaluation of all prevention studies that involve the Cox-2 selective agents such as Bextra to ensure that adequate precautions are implemented in the studies and that local Institutional Review Boards reevaluate them in light of the new evidence that these drugs may increase the risk of heart attack and stroke. A prevention trial is one in which healthy people are given medicine to prevent a disease or condition. The FDA issued the advisory because of recently released data from controlled clinical trials showing that the COX-2 selective agents (Vioxx, Celebrex, and Bextra) may be associated with an increased risk of serious cardiovascular events (heart attack and stroke) especially when they are used for long periods of time or in very high risk settings, such as immediately after heart surgery.