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the results of 14 randomized control trials involving the five COX-2 inhibitors, as well as other published and unpublished scientific information.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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