NEWS - Public Citizen Petitions FDA to Take Celebrex and Bextra Off the Market

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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other published and unpublished scientific information.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.

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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

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I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org