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Pfizer Will Add Heart Warning to Bextra Drug Label, FDA Says

Dec 9, 2004 | Bloomberg

Pfizer Inc., the world's largest drugmaker, will warn doctors about heart risk linked to its Bextra painkiller and will strengthen existing cautions about a serious skin reaction, U.S. regulators said.

The Food and Drug Administration posted information about the revised label on its Web site. Results from a new study of more than 1,500 patients who had just had cardiac surgery show that patients treated with Bextra for pain were more likely to have heart and blood clotting problems than did other patients who did not receive the drug, the FDA said.

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