Bextra Taken Off Market; Celebrex Gets Warning
Other Anti-Inflammatory Drugs Also to Carry Warnings of Heart, Stomach Risks
Bextra Has Special Risk
Nearly every study of Cox-2 drugs has shown that they relieve pain no better than older NSAIDs. But the drugs became popular because they are less likely than the older drugs to cause stomach bleeding.
Only a few studies have looked directly at Bextra's heart safety. One trial released in December suggested that the drug raised the risk of heart attacks in patients undergoing heart bypass surgery. Meanwhile, the FDA said it had received an abnormally high number of reports implicating Bextra in including toxic epidermal necrolysis and Stevens-Johnson syndrome.
"It has the same cardiovascular problem, no specific benefit, and this added worse skin risk," says Steven K. Galson, acting director of FDA's Center for Drug Evaluation and Research. "Bextra has a special risk in addition to the class risk."
Doctors wrote nearly 24 million prescriptions for Celebrex and 13 million for Bextra in 2004, according to FDA figures.
Along with stricter warnings, patients receiving Celebrex or other prescription anti-inflammatory drugs will now also receive medication guides outlining the risks and benefits of the drugs, Galson says. The additional warnings will begin appearing with the drugs within a few weeks, he says.
But the decision appeared to make it likely that Celebrex will be the only Cox-2 drug available to U.S. patients. Regulators said that Pfizer would have to provide significant new data showing Bextra's safety before the drug is allowed to return to the market.
"There would be a lot of factors that would have to go in their favor to do that," Galson said.
Vioxx Unlikely to Return
Officials from Merck told the FDA in February that they would likely move to return Vioxx to the market, despite a narrow 17-15 vote by an FDA advisory panel on whether the drug should be sold. FDA officials said Thursday that the company will be required to resubmit the drug, sold since 1998, for a new FDA approval before it can be marketed again.
Merck and makers of unmarketed Cox-2 drugs will also have to show "significant new safety data" before the drugs can be sold, Galson says.