FDA Approves Valdecoxib (Bextra™) for Treatment in Osteoarthritis and Rheumatoid Arthritis

On November 19, the U.S. Food and Drug Administration (FDA) approved Bextra^® (valdecoxib) for relief of the signs and symptoms of osteoarthritis (OA) and adult rheumatoid arthritis (RA).

Clinical trials lasting 3-6 months comparing Bextra to conventional NSAIDs have demonstrated that Bextra was as effective at treating the signs and symptoms of OA and RA, but was significantly less likely to cause serious gastrointestinal side effects. In placebo controlled trials, the incidence of endoscopically-detected gastroduodenal ulcers in patients treated with Bextra was similar to patients treated with placebo, (3-4% and 4%, respectively). The most common side effects were headache, abdominal pain, upset stomach and nausea.

Bextra is a selective COX-2 inhibitor and should not be taken by women in their third trimester of pregnancy or by individuals who have had allergic reactions after taking aspirin.