FDA Panel Questions Safety of Anemia Drug
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A panel of experts advising the Food and Drug Administration gave strong signals yesterday that it thinks the blockbuster anemia drug called erythropoietin is overused in cancer treatment and may, in fact, be shortening the lives of some patients who take it.
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WASHINGTON &#151; Safety concerns about a GlaxoSmithKline diabetes drug prompted some Democratic lawmakers on Wednesday to rebuke the Food and Drug Administration and call for increased regulation of the pharmaceutical industry.
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The U.S. Food and Drug Administration  said on Friday that Senate testimony by a veteran FDA  researcher regarding safety risks for five drugs does not  reflect the views of the agency.
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Doctors should stop using the anemia  drug Procrit, made by Johnson & Johnson's Ortho Biotech  Products L.P., if an oxygen-carrying agent in a patient's blood  reaches a certain level, the company said in documents released  on Wednesday.
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A top Food and Drug Administration  official said on Thursday she disagrees with an agency  scientist's warning that five drugs on the market have  significant safety risks.
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A U.S. consumer group called for an urgent Food and Drug Administration review of the safety of aspartame on Monday, but the FDA said there was no immediate need to do so despite a new study showing the sweetener may cause cancer.
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Washington - An expert with the United States Food and Drug Administration (FDA) has said on Thursday he was pressured by his agency to stifle study results showing the potential dangers of the anti-inflammatory drug Vioxx.
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The U.S. Food and Drug Administration said on Friday that Senate testimony by a veteran FDA researcher regarding safety risks for five drugs does not reflect the views of the agency.
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The U.S. Food and Drug Administration issued a new report on Tuesday describing potential risks of several medicines after criticism that it was lax in policing drugs once they were on the market.
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GAITHERSBURG, Md. - Amgen Inc. and Johnson &amp; Johnson's anemia drugs don't need changes in recommended doses to protect the safety of kidney patients, US advisers said.
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A top Food and Drug Administration official said on Thursday she disagrees with an agency scientist's warning that five drugs on the market have significant safety risks.
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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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Anemia drugs sold by Amgen Inc. and Johnson & Johnson will carry a new boxed warning advising doctors to choose the lowest dose needed to avoid blood transfusions, the U.S. Food and Drug Administration said on Friday.
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The US Food and Drug Administration (news - web sites) 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 &amp; Co.
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The Food and Drug Administration does very little to ensure the safety of the millions of people who participate in clinical trials, a federal investigator has found.
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A proposed leukemia drug should not receive federal approval, government advisers recommended Wednesday.
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U.S. FDA staff reviewers on Tuesday  said data on a new non-Hodgkin's lymphoma drug made by Inex  Pharmaceuticals Corp. and Enzon Pharmaceuticals Inc. may be  unreliable due to the trial's structure and size.