The Food and Drug Administration announced Thursday that Pfizer has agreed to stop selling Bextra, a popular arthritis drug, because its risks outweigh its benefits.
The FDA also will now require a “black box” warning the strongest warning on the labels of Pfizer’s blockbuster arthritis drug, Celebrex, and other, older prescription anti-inflammatory pain relievers such as ibuprofen and naproxen. The warning will highlight the drugs’ risks of heart attacks, strokes and bleeding of the digestive tract.
Over-the-counter anti-inflammatory pain relievers will have to add similar information to their labels, as well as a warning about rare, potentially fatal skin reactions, which the prescription drugs’ labels already carry.
The halting of Bextra sales is just the latest blow to COX-2 inhibitor drugs. A decade ago, the drugs were touted as “super aspirins” because it was thought they could relieve pain and inflammation while unlike aspirin leaving the stomach lining intact.
Of all the anti-inflammatory pain-relievers, Bextra has been the one most commonly cited in reports of severe skin reactions, Steven Galson, acting director of the FDA’s Center for Drug Evaluation and Research, said at a news conference.
The FDA asked Pfizer to stop selling Bextra because “it had no unique benefit, and it had the unique risk: the skin reaction,” John Jenkins, director of the FDA’s Office of New Drugs, said during the briefing. Galson said Celebrex is still on the market because the drug has a “positive risk/benefit balance.”
At the request of European regulators, Pfizer said, it is also suspending sales of Bextra in the European Union. About 7 million people worldwide have taken Bextra since it was launched in 2001, Pfizer spokeswoman Susan Bro said. And 28 million worldwide have taken Celebrex since its launch in 2000, Bro said.
Since concerns over cardiovascular safety spurred Merck to pull its arthritis drug Vioxx off the market Sept. 30, “the FDA has been engaged in a re-evaluation of this class of drugs,” Galson said.
In February, an FDA advisory panel unanimously concluded that Bextra, Vioxx and Celebrex, all COX-2 inhibitors, significantly raise heart and stroke risk. Nonetheless, a majority voted for keeping them on the market with restrictions. With Celebrex, the vote was 31-1 in favor of continued sales. But the panelists were nearly evenly split on whether Bextra or Vioxx should be on the market.
“Pfizer respectfully disagrees with FDA’s position regarding the overall risk/benefit profile of Bextra,” the company said in a statement. “For now, patients should stop taking Bextra and contact their physicians about appropriate treatment options.” Pfizer said it would discuss with the FDA how the company might resume selling Bextra.
Curt Furberg, who voted against Bextra and Vioxx at the February meeting, called the FDA’s announcement about Bextra “a victory for public health.”
“I did not expect them to have the guts to do it,” said Furberg, a medical epidemiologist at the Wake Forest University School of Medicine in North Carolina. “I feel vindicated.”