Editor note: On April 7, 2005, following scrutiny of the class of arthritis drugs known as NSAIDs and COX-2 inhibitors, the FDA announced planned regulatory actions. Pfizer was asked to withdraw Bextra from the market by the FDA. See: FDA Announces Changes For All NSAIDs; Bextra Withdrawn From Market
Dateline: November 20, 2001
FDA Approves Bextra
On November 19, 2001, the United States Food and Drug Administration (FDA) approved Bextra (valdecoxib) for the treatment of signs and symptoms of osteoarthritis and adult rheumatoid arthritis, and the pain associated with menstrual cramping. Bextra is classified as a COX-2 selective inhibitor, the second one marketed by Pharmacia Corporation and Pfizer Inc. The first of Pharmacia's COX-2 selective inhibitors, Celebrex (celecoxib), was approved by the FDA in 1998 and is now recognized as the number-one selling prescription arthritis medication.
Efficacy of Bextra
For arthritis pain, the recommended dose of Bextra is 10mg/once daily. In clinical trials with 5,000 participants, Bextra demonstrated comparable efficacy to conventional NSAIDs (specifically the non-steriodal anti-inflammatory drugs naproxen, ibuprofen, and diclofenac) while offering a better gastrointestinal safety and tolerability profile. At the recommended dose, the use of Bextra has not been associated with any increased risk of cardiovascular or renal complications versus the NSAIDs studied.
In clinical studies which lasted 3 to 6 months, Bextra 10mg/once daily was found to be as effective for treating the signs and symptoms of osteoarthritis as:
- ibuprofen 800mg. / three times daily
- diclofenac 75mg. / twice daily
- naproxen 500mg. / twice daily
Bextra was also found to be as effective for treating the signs and symptoms of rheumatoid arthritis as:
- naproxen 500mg. / twice daily
Safety Profile
According to three studies, Bextra was significantly less likely to cause endoscopically-detected gastroduodenal ulcers. In one placebo-controlled study of osteoarthritis patients, the incidence of endoscopically-detected gastroduodenal ulcers with Bextra 10mg (3%) was comparable to placebo (4%), and was approximately one-third that seen with naproxen 500mg/twice daily (10%).
In a second placebo-controlled study of osteoarthritis patients, the incidence of endoscopically-detected gastroduodenal ulcers with Bextra 10mg (4%) was again similar to placebo (4%), and one-third of the incidence found with ibuprofen 800mg/three times daily (14%) or diclofenac 75mg/twice daily (13%).
In a six-month study of both osteoarthritis and rheumatoid arthritis patients, Bextra at higher than therapeutic doses of 20mg or 40mg twice daily, demonstrated rates of endoscopically-detected gastroduodenal ulcers of 4% and 8% respectively, approximately one-third to one-half that seen with naproxen 500mg/twice daily.
Side Effects
Analysis of the studies shows Bextra to be well-tolerated with a significantly better overall upper gastrointestinal safety profile than the conventional NSAIDs studied. Among the most common reported side effects of Bextra were:
Related Resources
Source: Bextra Approved by FDA for Treating the Pain and Inflammation of Arthritis and Menstrual Pain, Pharmacia PRESS RELEASE, 11/19/01
First published: 11/20/2001
