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Public Citizen Press Releases
Providing the latest information about Public Citizen activities
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Public Citizen released the following Jan. 24, 2005:
Public Citizen Petitions FDA to Take Celebrex and Bextra Off the
Market
COX-2 Inhibitors Pose Heart Risks; Petition Filed Today with FDA
WASHINGTON, D.C. - Public Citizen today petitioned the U.S. Food and
Drug Administration (FDA) to immediately remove two widely prescribed
pain relievers, Celebrex and Bextra, from the market because they
increase the risk of heart attacks in patients. The group also urged the
FDA to cancel plans to approve two other drugs in the same class.
Celebrex (known generically as celecoxib) and Bextra (valdecoxib) are
among the vaunted class of drugs called COX-2 inhibitors, which are
touted as anti-inflammatory agents that cause less gastrointestinal
damage than older, standby pain relievers like aspirin or ibuprofen.
However, not only are their gastrointestinal benefits insignificant,
they elevate the risk of heart attack, Public Citizen's petition says.
In 2004, more than 23.9 million prescriptions were filled in the United
States for Celebrex; 12.9 million for Bextra.
"If a drug offers no unique benefit compared to other drugs for
treating the same problem (in this case arthritis and pain) but subjects
patients to a unique risk, it must be removed from the market," says the
12-page petition. The petition can be viewed at www.worstpills.org.
Vioxx, also a COX-2 inhibitor, was pulled from the market by Merck last
September after a clinical study showed that it increased the risk of
heart attacks.
Public Citizen's petition on Celebrex and Bextra examines the results
of 14 randomized control trials involving the five COX-2 inhibitors, as
well as other published and unpublished scientific information. The
other two COX-2 inhibitors are Prexige (lumiracoxib) and Arcoxia
(etoricoxib), neither of which has been approved for sale by the FDA.
The petition says that clinical studies suggest these drugs exhibit the
same cardiovascular toxicity as Vioxx, Celebrex and Bextra, and should
not be approved.
"The Food and Drug Administration should immediately ban the sale of
Celebrex and Bextra, which put millions of people, many of them elderly,
at risk of heart attack," said Dr. Sidney Wolfe, director of Public
Citizen's Health Research Group. "These drugs are not only more
expensive and more dangerous than older, safer pain relievers, they are
no better at protecting the gastrointestinal tract."
Public Citizen has a long history of identifying unsafe or ineffective
drugs. Vioxx, for example, was the ninth prescription drug to be taken
off the market in the past seven years that Public Citizen had
previously warned consumers not to use. For four of the drugs - Vioxx,
Baycol, Rezulin and Serzone - Public Citizen issued warnings more than
two years before their removal from the market. Public Citizen warned
patients not to use Celebrex three and half years before the government
announced that a study showed increased heart risks.
Public Citizen's Health Research Group recently launched a new Web
site, www.worstpills.org, that provides consumers with comprehensive
information about 538 drugs and warns them of 181 medications that
should not be used because they are either unsafe or ineffective.
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