Pfizer has agreed to stop selling Bextra, a popular arthritis drug, the Food and Drug Administration announced Thursday, because the FDA believes its risks outweigh its benefits.
The FDA will also now require a black box warning the strongest type of 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 digestive tract bleeding.
Over-the-counter pain relievers will have to add similar information to their labels, as well as a warning about rare, but potentially fatal skin reactions, which already is on the prescription drug labels.
The halting of Bextra sales is just the latest blow to COX-2 inhibitor drugs. A decade ago, COX-2 inhibitors had been touted as “super aspirins” because it was thought they could relieve pain and inflammation like aspirin while, unlike that drug, leaving the stomach intact.
Since cardiovascular safety concerns spurred Merck (MRK) to pull its blockbuster arthritis drug Vioxx off the market Sept. 30, “the FDA has been engaged in a re-evaluation of this class of drugs,” Steven Galson, acting director of the FDA’s Center for Drug Evaluation and Research, said at a press conference.
That process culminated in February with a three-day joint meeting of two FDA advisory committees
That process culminated in February with a three-day joint meeting of two FDA advisory committees, Galson said. Although panel members unanimously concluded that Bextra, Vioxx and Celebrex, all so-called COX-2 inhibitor drugs, significantly raise heart and stroke risk, a majority voted for keeping them on the market with restrictions to limit their use.
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.”
In its statement, Pfizer said it would discuss with the FDA how the company might resume “making Bextra available to physicians and patients.” The drug was approved by the FDA in November 2001.
It’s not clear how suspension of Bextra sales might affect Vioxx’s future. Merck executive Peter Kim surprised many at the advisory panel meeting when he suggested that Merck might resume marketing Vioxx if the advisory committee and the FDA conclude that the benefits of COX-2 inhibitors outweigh their risks.
“Merck respects the FDA’s decision” on COX-2 inhibitors, the company said Thursday in a statement. “We look forward to discussions with the FDA.”
Curt Furberg, who voted against Bextra and Vioxx at the February meeting and has published research about Bextra’s cardiovascular risks, called 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 Winston-Salem, N.C. “I feel vindicated.”