Guest guest Posted December 18, 2004 Report Share Posted December 18, 2004 I'm disturbed by the fear frenzy about Celebrex. I think it should remain available for patients who absolutely cannot stomach other NSAIDs and have low risk for heart problems. Let the doctors weigh (and communicate) the risks. A total ban seems excessive at this point. Sierra > Dec. 17, 2004 > > > Public Citizen to Call on FDA to Ban Celebrex and Bextra > > > Statement of Dr. Sidney Wolfe, Director of Public Citizen's Health > Research Group > > Even before today's announcement by Pfizer about the heart attack risks > associated with Celebrex, Public Citizen's Health Research Group was > preparing a petition to the U.S. Food and Drug Administration (FDA) to > ban both Celebrex and the other Pfizer COX-2 drug, Bextra. In February > 2001, we testified at an FDA advisory committee hearing that the cardiac > risks of Celebrex (and Vioxx) demanded a black box warning for both > drugs. Two months later, in the April 2001 issue of our newsletter Worst > Pills, Best Pills News (now online at worstpills.org), we urged patients > not to use either drug because there are safer alternatives. > > Today's announcement by Pfizer is quite misleading because the company > states that " These clinical trial results are new. The cardiovascular > findings in one of the studies (APC) are unexpected. " Four years ago, > after reviewing the results of the Pfizer-funded CLASS study, an FDA > physician stated that " the incidence of adverse events related to > cardiac ischemia (decreased blood flow to the heart) was higher in the > celecoxib [Celebrex] group ... and was most pronounced in the group of > patients not taking ASA (aspirin) " as a cardiovascular protective drug. > In these patients, the rate of heart attack was also highest in the > celecoxib group (0.2 percent) compared with users of the other two drugs > (0.1 percent). For all patients, on and off aspirin, there was a higher > incidence of atrial fibrillation, a type of heart rhythm disturbance, in > the celecoxib group compared to those taking ibuprofen or diclofenac. > Again this was more pronounced in the group not taking aspirin. Dr. > Throckmorton concluded by stating that " the data do not exclude a less > apparent pro-thrombotic [blood clot-forming] effect of celecoxib, > reflected in the relative rates of cardiac adverse events related to > ischemia. " > > Even earlier evidence of the danger of Celebrex was published more than > four years ago. In a study in the Aug. 29, 2000, Proceedings of the > National Academy of Sciences, the ability of rabbits to withstand > temporary experimental coronary artery occlusion (experimental heart > attack) was significantly impaired by treatment with celecoxib > (Celebrex), which completely blocked the cardioprotective effects of the > COX-2 enzyme. The authors of that study concluded that COX-2 enzyme is a > " cardioprotective protein. " Therefore, it is implied, drugs that block > this cardioprotective enzyme, such as COX-2 inhibitors, may neutralize > the protective effects of this important enzyme. > > The FDA should remove Celebrex and Bextra from the market immediately. > > > ====================================================================== > > Public Citizen fights for the rights of the individual citizen in the > halls of power and leads the battle to strengthen public health, > safety, and environmental protection. To retain our independence, > Public Citizen does not accept government or corporate funds. For more > information about Public Citizen, visit http://www.citizen.org. > > > > > > I'll tell you where to go! > > Mayo Clinic in Rochester > http://www.mayoclinic.org/rochester > > s Hopkins Medicine > http://www.hopkinsmedicine.org Quote Link to comment Share on other sites More sharing options...
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