The painkiller Bextra was taken off the market Thursday, and the government wants similar prescription drugs 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, sometimes fatal, skin reactions to Bextra on top of the risks shared by other similar drugs.
At issue are a broad class of painkillers known as nonsteroidal anti-inflammatory drugs, or NSAIDS. Bextra is a particular type of NSAID known as a Cox-2 inhibitor, a class of blockbuster sellers particularly popular among arthritis sufferers until a competitor Vioxx was pulled off the market last fall. That sparked questions about the safety of all similar drugs.
Pfizer’s Celebrex can still sell, the FDA announced Thursday. But it, and all other prescription NSAIDS, must carry a black-box warning on its label that users may face an increased risk of cardiovascular side effects.
Scientists don’t have enough information yet to tell if one of the remaining prescription painkillers is safer than another, FDA officials stressed. But, the agency decided that Bextra was more dangerous than its competitors because of the added skin side effect.
In addition to the prescription drugs, the FDA asked manufacturers of over-the-counter NSAID painkillers to revise their labels to clarify information about the risks of cardiovascular incidents, gastrointestinal bleeding and rare but serious skin reactions.
That doesn’t mean the nonprescription drugs are dangerous, FDA officials stressed but the strengthened wording will make clear that patients should take those drugs only at the labeled dosage for short periods of time.
“People should not have a concern about continuing to take those products per those directions,” said Dr. Steven Galson, acting director of FDA’s Center for Drug Evaluation and Research.
For users of prescription-strength NSAIDS, the government said there was no reason to panic but that people should consult their physicians about which painkiller is best suited for them and to take the lowest effective dose.
“All these risks we’re talking about have already been known,” Galson stressed. “People should not worry about, from today to tomorrow, stopping the products.”
Pfizer’s advice to Bextra users: “For now, patients should stop taking Bextra and contact their physicians about appropriate treatment options.”
Pfizer said it “respectfully disagrees” with FDA that Bextra was too risky to continue selling, and pledged further discussions with the agency about the possibility of returning it to the market.
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 although it only narrowly backed Bextra. The panel said Vioxx posed the greatest heart risk and that Celebrex seemed have the fewest cardiovascular side effects among the Cox-2 drugs. It also recommended that the prescription drugs carry strong warnings, and that more study be done to better understand the drugs’ risks.
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