FDA MedWatch – Strengthened warnings on Bextra (valdecoxib)

MedWatch – The FDA Safety Information and Adverse Event Reporting Program 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. Read the 2004 MedWatch safety summary, including links to the Talk Paper, Questions and Answers, and revised label at: http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm#Bextra

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