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Bextra (valdecoxib) - Dec 10, 2004

Audience: Healthcare professionals and consumers

The 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]

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