The painkiller Bextra was taken off the market Thursday, and the government wants other drugs in the same class to carry the strongest possible warnings about increased risk of heart attack and stroke among the millions of people who rely on them.
Pfizer Inc. suspended sales of Bextra in the United States and the European Union at the request of the Food and Drug Administration and European regulators. The company said that the FDA, in seeking Bextra’s withdrawal, cited a risk of serious skin reactions to Bextra on top of the risks shared by other similar drugs.
The boxed warning recommended for the other non-steroidal anti-inflammatory prescription drugs is the strongest available to the FDA.
In addition to the prescription drugs, the FDA asked manufacturers of related over-the-counter painkillers such as Advil and Motrin to revise their labels to include information about the risks of cardiovascular incidents and gastrointestinal bleeding.
“Today’s actions protect and advance the health of the millions of Americans who rely on these drugs every day,” said Dr. Steven K. Galson, acting director of FDA’s Center for Drug Evaluation and Research.
The risks posed by Bextra outweigh its benefits, the FDA said.
The FDA has been studying the safety of the so-called Cox-2 inhibitors since Merck & Co. voluntarily pulled Vioxx from the market Sept. 30 after heart problems were reported in some users. Once blockbuster sellers, the painkillers were particularly popular among arthritis sufferers.
“For now, patients should stop taking Bextra and contact their physicians about appropriate treatment options,” Pfizer said in a statement Thursday.
Pfizer said it planned further discussions with the FDA about the possibility of returning Bextra to the market.
“Pfizer respectfully disagrees with FDA’s position regarding the overall risk-benefit profile of Bextra,” the company said.
Pfizer shares fell about 3 percent soon after Thursday’s opening bell on the New York Stock Exchange.
In February, advisers to the FDA had recommended that people who depend on Celebrex, Bextra and Vioxx be allowed to continue to use them despite the health risks.
The panel said Vioxx posed the greatest risk and that Celebrex had the fewest side effects. It recommended that the prescription drugs carry strong warnings and that more study be done to get a better understanding about the drugs.