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FDA, Bristol-Myers
warn on antibiotic Tequin
By Jennifer Corbett Dooren Last Update: 1:06 PM ET Feb 16, 2006 WASHINGTON (MarketWatch) -- The U.S. Food and Drug Administration said an antibiotic made by Bristol-Myers Squibb Co. (BMY) would carry stronger warnings about the threat of rare life-threatening events from blood-sugar changes. The FDA said it's received continued reports of serious cases of hypoglycemia, or low blood sugar, and hyperglycemia in patients receiving Tequin, an antibiotic used to treat pneumonia, bronchitis and other infections. "Since the approval of Tequin in 1999, there have been rare cases of life-threatening events reported globally in patients treated with the drug," the FDA said in a statement. Most of the cases were reversed but a few were fatal. The FDA said the drug is no longer recommended for use in people with diabetes. In 2002, warnings were added to Tequin's label discussing the risk of low and high blood sugar. The changes announced Thursday will include a stronger warning and provide additional information to health-care professionals about they types of patients more likely to have blood-sugar problems, the FDA said. Bristol-Myers Squibb did not immediately return a request for comment. The FDA said it would continue monitoring Tequin's safety "to ensure that its benefits outweigh the risks to patients." -Contact: 201-938-5400
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