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On January 24, 2005 Public Citizen petitioned the Food and Drug Administration (FDA) to immediately remove the painkillers 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.
Public Citizen states that the so called gastrointestinal benefits of Cox-2 drugs are insignificant and while they elevate the risk of heart attack, the petition says. In 2004, more than 23.9 million prescriptions were filled in the U.S for Celebrex®; 12.9 million for Bextra®.
"If a drug offers no unique benefit compared to other drugs for treating the same problem but subjects patients to a unique risk, it must be removed from the market," says the 12-page petition.
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the results of 14 randomized control trials involving the five Cox-2 inhibitors, as well as other published and unpublished scientific information.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® and Arcoxia®, neither which have 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."
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