Worldwide. Pfizer is updating the valdecoxib (Bextra) label worldwide with information on a rare skin reaction, and has advised of an increase in cardiovascular events in patients undergoing coronary bypass surgery who receive either valdecoxib alone or in combination with parecoxib. Data from spontaneous reports show that the skin reaction has been reported at a greater rate with valdecoxib than with other cyclo-oxygenase-2 inhibitors, and that the risk mainly exists in the first two weeks of valdecoxib therapy.

Reference:

Media Release from Pfizer, 15 October 2004. Available on the Internet at www.pfizer.com