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Public Citizen to Call on FDA to Ban Celebrex and Bextra

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 www.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.

Please visit www.worstpills.org for more information.