FDA Updates Bextra Label With Boxed Warning

According to the FDA, a "boxed" warning, strengthening previous warnings about the risk of life-threatening skin reactions and a new bolded warning contraindicating the use of Bextra in patients undergoing coronary artery bypass graft surgery will be added to the label. The FDA will also seek input from the public and from outside experts on the appropriate uses for Bextra and other NSAIDs at a previously-announced Advisory Committee meeting, to be held early in 2005. Read the FDA Talk Paper.