Bextra (valdecoxib) - Dec 10, 2004
Audience: Healthcare professionals and consumersThe FDA announced important new information on side effects associated with the use of Bextra, a COX-2 selective non-steroidal anti-inflammatory drug (NSAID) indicated for the treatment of osteoarthritis, rheumatoid arthritis and dysmenorrhea (menstrual pain). 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 (CABG) surgery were added to the label.
[December 9, 2004 - Talk Paper - FDA]
[December 9, 2004 - Questions and Answers - FDA]
[November, 2004 - Label - Pfizer]