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The arthritis drug Bextra will now carry a warning on its label about possible heart and blood-clotting problems, the Food and Drug Administration said Thursday.
Bextra is a so-called COX-2 inhibitor, the same type of drug as Vioxx, whose maker, Merck, pulled it off the market Sept. 30 because of safety concerns. A company study found more heart attacks and strokes in patients who took Vioxx than in those given a placebo.
Bextra's labeling change comes three weeks after FDA scientist David Graham told a Senate committee that it is one of five drugs deserving closer scrutiny.
The FDA has come under fire for its handling of Vioxx. A study in 2000 found more heart attacks and strokes in arthritis patients on Vioxx than in those on the pain reliever naproxen. An FDA panel in February 2001 recommended noting that fact on the label, but it wasn't added until April 2002.
Pfizer, maker of Bextra and Celebrex, the only COX-2 inhibitors left on the U.S. market, raised the possibility of cardiovascular problems with Bextra in an October letter to health-care professionals. The letter told of a new study comparing Bextra to a placebo for pain relief in patients after heart bypass surgery.
Pfizer submitted a final report of the study to the FDA on Nov. 5. It found more heart attacks, strokes and blood clots in the Bextra group. The drug's label now has a bold-faced warning against using it in heart bypass patients, for whom it is not approved. It also notes that studies in arthritis patients have not been large enough or long enough to detect an increased risk of cardiovascular problems.
The relative speed with which the cardiovascular information was added to Bextra's label does not reflect a change in the ''overall attitude'' of the FDA toward drug safety, Douglas Throckmorton, acting deputy director of the agency's drug division, said Thursday.
Throckmorton said the 2000 Vioxx study was more difficult to interpret than the Bextra study because it compared the drug to naproxen, not a placebo. ''Labeling is just terribly important to get right,'' he said. ''I'd prefer not to contrast the two actions.''
Bextra's label also now carries a stronger ''black box'' warning about rare, potentially fatal skin reactions.
Studies have not linked Celebrex to cardiovascular problems. But an editorial this week in Annals of Internal Medicine advised doctors not to prescribe any COX-2 drugs to patients at risk for heart disease until more is known about why Vioxx caused more heart attacks and strokes.
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