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Pfizer said it would conduct further studies to determine whether its COX-2 inhibitor Bextra® (valdecoxib) raises the risk of cardiovascular problems in arthritis patients.
Approved and introduced in the U.S. market in 2001, Bextra is indicated for the relief of signs and symptoms of osteoarthritis and adult rheumatoid arthritis and for the treatment of primary dysmenorrhea.
Pfizer said available clinical information from nearly 8,000 patients treated with Bextra from six to 52 weeks for rheumatoid arthritis and osteoarthritis suggests no increased risk of cardiovascular events.
However, Pfizer noted that in two trials involving high-risk surgery known as coronary artery bypass graft, an increase in heart attack and stroke was observed in patients receiving Bextra alone or in combination with the investigational drug parecoxib. Pfizer emphasized that Bextra is not approved for use in any surgical setting in the United States.
Merck and Co. recently removed its COX-2 inhibitor Vioxx® from sale after a recent trial found that it doubled the risk of heart attack and stroke in patients who took the drug for more than 18 months.
Source:
Medical Week Staff, week
of October 16, 2004
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