FDA wants big warning on Glaxo diabetes drug: report
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Food and Drug Administration officials are pushing for a "black box" warning on GlaxoSmithKline Plc's hard-hit diabetes drug Avandia, the Wall Street Journal reported, citing sources.
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The U.S. Food and Drug Administration is facing new questions about its ability to police the safety of medicines after they reach the market following concerns about a widely used diabetes drug.
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NEW YORK  - Patients with diabetes, especially women, who take thiazolidinediones, which include commonly prescribed drugs such as Avandia and Actos, may have an increased risk of developing cancer, according to a new report.
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WASHINGTON - GlaxoSmithKline PLC's Avandia, the world's best-selling diabetes drug last year, will carry US regulators' strongest warning on the risk of heart attacks.
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The Food and Drug Administration warned yesterday that anemia-fighting drugs called erythropoietins, which had $10 billion in U.S. sales last year, are being used so aggressively that they may be harming some patients.
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Pfizer is the latest drug maker to warn that a product already on the market may pose serious health risks. It took outrage from activists in September to get the Food and Drug Administration to require warning
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The U.S. Food and Drug Administration on Wednesday ordered all sleep disorder drugs to carry stronger warnings about their risks, including severe allergic reactions.
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A medical researcher who testified at a House hearing about the safety of the popular diabetes drug, Avandia, said he received the veiled threat of a lawsuit by a high-ranking drug company executive.
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Federal health officials cautioned women Friday that use of a GlaxoSmithKline drug during the first three months of pregnancy shows possible links to birth defects.
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The US drug safety watchdog warned Monday on its website that several Chinese-made 'dietary supplements' contain the active ingredient found in Viagra, and could be harmful to consumers.
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An independent analysis of thousands of older people with diabetes found that those treated with the widely used drug Avandia had significantly elevated risks of heart attack and death.
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U.S. regulators have asked for more data  on Novartis AG's  diabetes drug Galvus, possibly  delaying approval of the potential blockbuster by a year, which  dented its shares while boosting its main rival's.
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The arthritis drug Bextra will begin carrying a warning on the label about possible heart and blood-clotting problems, the Food and Drug Administration said yesterday.
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The safety of GlaxoSmithKline Plc's controversial diabetes drug Avandia was attacked in a new analysis by German researchers on Wednesday, dealing a fresh blow to the group's second-biggest product.
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Early results from a new study of GlaxoSmithKline Plc's diabetes drug Avandia showed no difference in the risk of heart problems between patients taking the controversial drug and those who took other diabetes drugs, researchers said on Tuesday.
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GlaxoSmithKline PLC, the world's second-largest drug maker, began a campaign to challenge a report that linked its diabetes drug Avandia to heart risks and caused its stock to decline 11 percent in the eight days through Tuesday. The shares rose yesterday.
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Dec. 9, 2004 - New documents uncovered by ABC News suggest GlaxoSmithKline, the maker of the popular antidepressant Paxil, failed to disclose important information about the possibility of an increased risk