FWD:RSDSA-Updated Info Regarding Celebrex

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From: byrd45 (Original Message) Sent: 10/17/2006 4:20 PM
Aug 31, 2006 Celebrex is a threat to the heart Updated 8/30/2006 11:39 PM ET By Liz Szabo, USA TODAY Research has long suggested that the popular pain reliever Celebrex might prevent colorectal polyps, which can lead to cancer. But new research shows that Celebrex's cancer- fighting potential is overshadowed by the danger it poses to the heart, leading researchers to warn patients not to take Celebrex to prevent colorectal disease. SAFETY CONCERN: Some patients back on Celebrex In two studies in today's New England Journal of Medicine, which together included nearly 3,600 patients, doctors examined whether Celebrex might prevent polyps from reappearing in patients who already had had colon growths removed. Doctors randomly assigned patients to receive either Celebrex or placebos for three years. The studies were paid for by the National Cancer Institute (NCI) and Pfizer, which makes Celebrex. Celebrex dramatically reduced the risk of recurrent polyps: 33% to 43% of patients who took the pain reliever developed colorectal growths within three years, vs. 50% to 60% of those who took placebos, the two studies show. Patients who took the highest doses appeared to get the most protection. Celebrex was especially effective in preventing advanced polyps. But Celebrex doubled the risk of serious cardiovascular problems, including heart attacks, strokes, heart failure and death, according to a separate analysis in the journal Circulation released Wednesday. That makes Celebrex too risky to be used for polyp prevention, according to an editorial in the New England Journal by Bruce Psaty of the University of Washington and John Potter of the Fred Hutchinson Cancer Research Center in Seattle. Most colon cancers develop from polyps. Colorectal cancer is the second-leading cause of cancer death, killing 55,000 Americans a year, according to the American Cancer Society. Doctors don't know exactly why Celebrex sometimes leads to heart attacks and strokes, says Scott Solomon, an author of the Circulation paper. But he notes that Celebrex elevated blood pressure only in patients who took it twice a day, not in those who took it once a day. That suggests the dose may affect its safety, he says. Doctors don't know how this will affect patients who take Celebrex for arthritis, because they typically use much smaller doses, says Ernest Hawk of the NCI, an author of one of the New England Journal papers. Concern over medication such as Celebrex has grown in the past two years. Doctors stopped prescribing Celebrex to patients in the two studies in 2004 after noticing the heart risks, Hawk says. Doctors continued to monitor patients' health. Because of the potential side effects, the Food and Drug Administration imposed a "black box" warning last year on Celebrex and other prescription non-steroidal anti-inflammatory drugs. The makers of two similar drugs, Vioxx and Bextra, pulled those products because of the risk of heart attacks and strokes