# Cox-2 Inhibitors & their risks



## M&M (Jan 20, 2002)

This was posted to the Co-Cure mailing list. Thought it might be of interest for any of us who take Cox-2 inhibitors for pain control.*************************************************Experts To Discuss Arthritis Drug RisksNovember 12, 2004WASHINGTON (AP) -- Government experts asked to discuss the safety of arthritisdrugs in the same class as Vioxx will get an avalanche of paper, includingconfidential unpublished trials and their first glimpse at long-term safetystudies.The Food and Drug Administration is asking its arthritis advisory committeemembers to block out Feb. 16-17 for the session.Still there's no guarantee that the volume of information will be enough forthe panel to answer the most important question: Do the same heart safetyconcerns that pushed Vioxx off the market apply to related painkillers?"I don't know whether there is enough data available to say there is a classeffect that would be appropriate to generalize to all cox-2 inhibitors aboutcoronary artery disease. But that is what we are all concerned about," said Dr.Gary Stuart Hoffman, a member of the FDA arthritis advisory panel."It's possible that the committee will decide there isn't adequate data andadditional studies or ongoing studies need to be continued," said Hoffman,chairman of rheumatic and immunologic diseases at the Cleveland ClinicFoundation.The crucial issue, say leading cox-2 inhibitor researchers, is whether the newpainkillers cause blood clots, which trigger heart attacks and strokes. Or dothe drugs simply fail to prevent blood clots in people otherwise at risk forheart woes?"I tell people often that in building a better ... nonsteroidalanti-inflammatory drug, we lost something in the mix. What we lost was theability to thin the blood, which is what aspirin and like drugs used to do,"said Dr. John Cush, another arthritis advisory committee member and chief ofrheumatology and clinical immunology at Presbyterian Hospital in Dallas.The panel also is expected to discuss whether it's ethical to give dummy pillsto patients in pain. Placebo-controlled trials are the gold standard. Anadvisory panel in June dismissed placebos as unethical, even for a few weeks.According to a presentation this week by the FDA's Office of New Drugs deputydirector, government arthritis experts will review all available data aboutcox-2 inhibitors, including Vioxx, Bextra and Celebrex.The data includes a placebo-controlled trial involving 3,600 patients thatponders whether Celebrex prevents colon polyps and another that tests thepopular painkiller as a possible Alzheimer's treatment, according to Dr. SandraKweder's presentation.Independent safety and monitoring boards for those two Celebrex studies areclosely watching for any spike in heart attacks or strokes in the monthly dataupdates. So far, there has been no repeat of the doubling of risk of suchcardiovascular woes that led Merck & Co. to withdraw Vioxx from the market.In light of a preliminary study that showed Bextra doubled risk of heart attackand stroke in patients with heart disease, the federal advisers will also lookat additional studies of that painkiller.In a press release, Pfizer dismissed the study, presented at the American HeartAssociation annual meeting, as "unsubstantiated conclusions" that had not beensubjected to independent scientific review.Dr. Curt Furberg, the Wake Forest University School of Medicine professor ofpublic health sciences who did the Bextra analysis, says it points to safetyconcerns with other painkillers. The FDA has asked Furberg to attend theFebruary meeting."With the information on Bextra, you really have to ask does this apply to allof them?" he said.Patients are asking themselves the same question.Dr. M. Peter Lance is the principal investigator of a three- to five-year studylooking at whether Celebrex -- alone or used with selenium -- can preventrecurrence of colon cancer. Since the Vioxx controversy, Lance has held townhall style meetings to allay concerns among healthy patients enrolled in thetrial."There have been a lot of questions. We have done everything in our power to beopen," said Lance, a professor of medicine at the Arizona Cancer Center, partof the University of Arizona. "So far, we have not seen a significant dropoff."Copyright 2004 The Associated Press. All rights reserved. http://www.intelihealth.com/IH/ihtIH/EMIHC...ml?d=dmtICNNews


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