FDA review also shows Glaxo diabetes drug risk
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A U.S. Food and Drug Administration preliminary analysis found a level of heart-attack risk with GlaxoSmithKline Plc'sdiabetes drug Avandia similar to what was reported in a study earlier this week, the agency confirmed on Friday.
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The controversy surrounding GlaxoSmithKline's diabetes drug Avandia mounted Wednesday as a medical expert prepared to tell lawmakers the British drug maker threatened him with legal action when he first raised questions about the treatment's safety.
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The U.S. Food and Drug Administration on Friday asked an outside group to review the way the agency monitors safety risks of medicines after they hit the market, such as Merck & Co. Inc.'s withdrawn painkiller Vioxx.
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NEW YORK - An internal survey conducted by the Food and Drug Administration (FDA) indicates that 66% of FDA scientists lacked confidence that the agency adequately monitors the safety of prescription drugs that are already on the market.
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A leading diabetes doctor sent the Food and Drug Administration a letter seven years ago that warned of the heart risks of the drug Avandia.
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The Food and Drug Administration on Thursday ordered a review of all prevention studies involving drugs such as Celebrex and Bextra, which have been associated with increased risk of heart problems. The agency also urged the public to limit use of over-the-counter pain medications.
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GlaxoSmithKline Plc fired another salvo in defense of diabetes treatment Avandia on Tuesday by taking out full-page advertisements in at least a dozen major U.S. newspapers in an attempt to reassure patients of the safety of the widely used medicine.
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The US Food and Drug Administration on Thursday ordered the review of preventative studies involving Pfizer Inc.&#39;s painkillers Celebrex and Bextra, in light of recent evidence they may increase the risk of heart attack and stroke.
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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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GlaxoSmithKline fired another salvo in defense of its diabetes treatment Avandia on Tuesday by taking out full-page advertisements in at least a dozen major U.S. newspapers in an attempt to reassure patients of the safety of the widely used medicine.
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U.S. Food and Drug Administration officials are pushing for a "black box" warning of the risk of heart attack on GlaxoSmithKline Plc's diabetes drug Avandia, the Wall Street Journal reported on Wednesday, citing unnamed sources.
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A drug commonly used to control diabetes increases the risk of heart attacks and possibly death, researchers reported yesterday in the latest episode to raise safety concerns about a widely prescribed drug.
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A Food and Drug Administration reviewer who has criticized the agency for being lax in monitoring drug safety said on Thursday five medicines on the market need close scrutiny for possible side effects.
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clozapine and olanzapine -- may carry a small risk of an increased risk of diabetes, new research shows.
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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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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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A panel is examining claims that GlaxoSmithKline tried to suppress a doctorâs criticism of its drug Avandia.