Bextra Taken Off Market; Celebrex Gets Warning
Other Anti-Inflammatory Drugs Also to Carry Warnings of Heart, Stomach Risks
Bextra Has Special Risk continued...
"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.
Warnings for All
Data presented to experts in February suggested that some of the
including naproxen, may carry a lower heart risk. But the FDA declined to designate any of the drugs as a less hazardous alternative, saying reviewers did not have enough evidence to rank the remaining drugs in terms of their safety.
Drug companies have produced no data on heart safety for many of the older NSAID drugs, while some drugs have shown limited evidence of an increased risk.
Officials suggested the higher dosage normally seen with prescription drugs led them to place strong black box warnings on those products while ordering somewhat weaker alerts for over-the-counter forms.
The decision will cause some drugs sold in both forms, including naproxen, to carry different warnings depending if they're prescription or nonprescription.
"We don't see any data that would suggest that short-term use of low doses of the products that are currently sold over the counter increase the risk of serious cardiovascular events," says John Jenkins, MD, director of the FDA's Office of New Drugs.
Still, officials say they are planning to ask all NSAID manufacturers to review safety data surrounding their drugs and submit the findings to the FDA.
The agency also asked Pfizer to conduct a broad new safety study of Celebrex in an effort to settle conflicting data on the drug's heart safety. Several studies, including one halted late last year at the National Institutes of Health, suggested
while others suggested that patients taking lower doses of the drug had no increased risk.
"We think it's very important to do a new, well-designed study to really try to nail down the question about whether Celebrex itself has a unique risk," Jenkins said.