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's  diabetes drug Avandia similar to what was reported in a study earlier this week, the agency confirmed on Friday.
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In both studies, the drug Avandia, made by GlaxoSmithKline, raised risks of heart failure.
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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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When a congressional committee holds a hearing next Wednesday, the subject will be the safety of the diabetes drug Avandia and whether federal drug regulators have paid close enough attention to its potential risks.
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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to review the way the agency monitors safety risks of medicines after they hit the market, such as Merck & Co. Inc.'s withdrawn painkiller Vioxx.
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An executive of the company that makes the diabetes drug Avandia said a researcher who was among the first to link it to heart problems would be held liable for the $4 billion GlaxoSmithKline PLC lost in stock value as a result of his findings, Dr. John B. Buse testified before congressional investigators yesterday.
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The government's own preliminary evaluation of the diabetes pill Avandia confirms the heart risks reported in a study earlier this week and suggests that as many as 60,000 to 100,000 heart attacks might be linked to its use since it came on the market eight years ago, a leading member of Congress...
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A leaked, confidential journal article could get Glaxo in hot water.
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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 pair of Food and Drug Administration advisory panels called yesterday for new warnings for the widely used diabetes drug Avandia because of evidence that it significantly raises the risk of heart attack, but they stopped short of recommending that the drug be pulled from the market, as some FDA...
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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 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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GlaxoSmithKline PLC faces a US investor lawsuit claiming Europe's biggest drug maker misled shareholders about the safety of the diabetes drug Avandia.
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Dr. Steven Galson, acting director of the Food and Drug Administration&#39;s Center for Drug Evaluation, announced Friday that the FDA will review five popular drugs whose safety is being questioned.
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An FDA review of AstraZeneca Plc&#39;s (AZN.L: Quote, Profile, Research) (AZN.N: Quote, Profile, Research) Exanta questioned the experimental drug&#39;s
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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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Washington, Dec 16 : One-fifth of the US Food and Drug Administration (FDA) scientists surveyed as part of an official review have said they had been pressured to recommend approval of a new drug despite their reservations about its safety, effectiveness