CBS/AP) Pfizer Inc. plans a major study to see if its anti-arthritis medication, Celebrex, increases the risk of heart attack and stroke. The announcement comes three weeks after Merck & Co. pulled Vioxx, a rival arthritis medication, from the market because the drug doubled the risk of heart attack and strokes in patients taking the medication longer than 18 months.
Celebrex and Vioxx are both in a class of drugs called cox-2 inhibitors. Last week, Pfizer said a study showed that Bextra, another cox-2 inhibitor it sells, increased the risk of heart attacks in patients that had coronary bypass operations. In a related development, a top U.S. Food and Drug Administration official said new pain relievers in the same class as Vioxx and Celebrex face increased scrutiny because scientists do not have a full comprehension of how exactly they work in the body.
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Acting FDA deputy commissioner Dr. Janet Woodcock also said the agency would hold an advisory committee meeting early next year to discuss safety of the drugs known as cox-2 inhibitors. "We are far from understanding the complex mechanisms that lead to this toxicity," said Woodcock, who was speaking at the American College of Rheumatology's annual meeting in San Antonio.
Woodcock's statements don't bode well for Whitehouse Station, N.J.-based Merck, which has another cox-2 inhibitor called Arcoxia currently under review at the FDA. The agency is slated to rule on whether to approve the drug by Oct. 30. Woodcock said the FDA will examine the length and size of the safety data drug companies offer when deciding whether to approve a new cox-2.
Analysts don't believe Merck has enough long-term data to establish that Arcoxia has a safe cardiovascular profile. In a statement, Pfizer said that in completed studies and ongoing trials, Celebrex has proven to be safe and also has shown it could help patients with cardiovascular disease. The study, which is expected to begin next year, will enroll more than 4,000 patients around the world.
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