USA. The US FDA has asked Pfizer to withdraw valdecoxib (Bextra) from the market because of:
• Lack of adequate data on the cardiovascular safety of long-term use of valdecoxib (Bextra), along with the increased risk of adverse cardiovascular events in short-term coronary artery bypass surgery (CABG) trials;
• reports of serious and potentially life-threatening skin reactions, including deaths, in patients using valdecoxib (Bextra) and,
• lack of any demonstrated advantages for valdecoxib (Bextra) compared with other NSAIDs.
Public Health Advisory, 7 April 2005. Available on the internet at www.fda.gov