Bextra Taken Off Market; Celebrex Gets Warning
Other Anti-Inflammatory Drugs Also to Carry Warnings of Heart, Stomach Risks
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.
Standing Up for Patient Safety
The FDA's decision on Bextra went against the February recommendations of the FDA's advisors, who voted 17 to 13, with two abstentions, to allow the drug to stay on the market. Galson said that the decision reflected a conservative approach to the panel's largely split recommendations on Bextra and other drugs.