Injury News

Source: Public Citizen

A consumer group petitioned the Food and Drug Administration to remove the arthritis drugs Celebrex and Bextra from the market. The group claims that both painkillers from Pfizer Inc. increase the risk of heart attacks in patients.

Celebrex and Bextra are part of the same family of drugs called COX-2 inhibitors as Vioxx, which was pulled from the market by Merck & Company on September 30, 2004, after a study confirmed that it increases a patients’ risk of heart attack and stroke. Public Citizen also urged the FDA to cancel plans to approve two other drugs in the same class.

After the Vioxx recall, Celebrex became the top selling drug in its class. In 2004, more than 23.9 million prescriptions were filled in the United States for Celebrex; 12.9 million for Bextra.

Public Citizen said the 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the results of 14 randomized control trials involving the five COX-2 inhibitors, as well as other published and unpublished scientific information.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,” Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, said. “These drugs are not only more expensive and more dangerous than older, safer pain relievers, they are no better at protecting the gastrointestinal tract.”

The FDA will hold a meeting of two agency committees to discuss safety concerns regarding COX-2 inhibitors including Celebrex and Bextra.

In an earnings report released on Friday, Pfizer reaffirmed its confidence in Celebrex and Bextra despite concerns regarding the cardiovasular safety of both painkillers.

Pfizer agreed on Dec. 20 to stop all direct-to-consumer advertising on Celebrex while the FDA evaluated the new and conflicting scientific data on adverse cardiovascular events associated with the drug.

The National Cancer Institute stopped on Dec. 17 an ongoing clinical trial investigating a new use of Celebrex because of an increased risk of heart attack in patients taking Celebrex versus taking a placebo (sugar pill).