New York - In light of the increased focus on alternative treatment options for people with arthritis, Pfizer plans to conduct further studies to confirm the long-term cardiovascular safety profile of its anti-inflammatory drug Bextra.
The announcement comes just two weeks after Merck & Company withdrew its blockbuster arthritis pain drug Vioxx, a high-margin product that had accounted for almost 20 percent of its profit, because of an increased risk of heart attacks and stroke.
Pfizer's Bextra, which was introduced in the United States in 2001, is indicated for the relief of osteoarthritis and adult rheumatoid arthritis and for the treatment of primary dysmenorrhea, or painful menstrual cramps.
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Since 2002, Bextra's label has included information regarding the risk of a very rare but serious skin reaction. Pfizer said this risk also exists with many other medications.
The risk exists with Bextra primarily within the first two weeks of therapy and, while very rare, it occurs at a reported rate greater than similar products such as arthritis drug Celebrex. Pfizer said it is working with regulatory authorities to update the Bextra product label.
Immediately after Merck's announcement in September about Vioxx, Pfizer said it was "confident in the long-term cardiovascular safety" of Celebrex.
Pfizer also reviewed trial data about the cardiovascular profile of Bextra. Available clinical information for Bextra suggests there is no increased risk of cardiovascular thromboembolic events, or blood clots, in people treated for osteoarthritis and rheumatoid arthritis, Pfizer said.
In addition, Bextra has been studied in several surgical settings. In studies in general surgery, Bextra in combination with the investigational drug parecoxib showed no increased risk of cardiovascular thromboembolic events. However, in two trials in a high-risk surgery known as coronary artery bypass graft, an increase in cardiovascular events was observed in patients receiving Bextra alone or in combination with parecoxib, the company said.
Bextra is not approved for use in any surgical setting in the United States.
New York pharmaceuticals giant Pfizer earned almost $4-billion (about R26-billion) on sales of $45-billion (about R290-billion) in 2003. - Sapa-AP
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