PUBLIC CITIZEN TO CALL ON FDA TO BAN CELEBREX AND BEXTRA
2004-12-17 13:59 (New York)
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 is a national, nonprofit consumer advocacy organization
based in Washington, D.C. For more information, please visit
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