Regulators add warning to Bextra, allow new indication

The FDA has provided a new warning and a new indication for Celebrex, the only remaining Cox-2 inhibitor left on the market. The new warning will highlight the added risks of heart attacks and other cardiovascular conditions. Celebrex was also approved for use against ankylosing spondylitis, a form of spinal arthritis that affects about 400,000 Americans.

Sales of Celebrex have plunged 45 percent in the second quarter of 2005, with total sales of $401 million. Pfizer's other Cox-2 inhibitor, Bextra, was pulled from the market after the FDA asked the company to withdraw the anti-inflammatory after a review of its cardiovascular risks.

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