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FDA publishes a note on its Web site regarding Bextra warnings
-December 9, 2004
The FDA has published a note on its Web site, alerting consumers of the new Bextra labeling warnings. Bextra is an arthritis pain reliever drug made by Pfizer, Inc.
According to the FDA, the new warnings will include the possible risk of heart and blood clotting problems among patients who have just undergone heart bypass surgery. The agency says in a statement posted on its Web site that, "based on what we know now, the overall benefit of Bextra outweighs the risk when used in properly selected patients as directed in the approved labeling."
In a study of more than 1,500 heart surgery patients that were treated with Bextra for pain, the agency said they were more likely to have problems like heart attacks, strokes and blood clots in the legs or lungs.
The new Bextra label will also include the strongest issued government warning, a "black box" warning, about the risks of serious skin reactions when taking the drug.
Following the September announced Vioxx recall there has been debate on the safety of both Pfizer's Bextra and Celebrex, the only two remaining cox-2 inhibitors on the market.
In October, Pfizer announced two small clinical trials of Bextra showed heart bypass patients had an increased risk of stroke and heart attack. At that time, Pfizer said it would be adding risk of serious skin reactions to the drug's packaging.
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