FDA staff cites safety concern with Lilly drug
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Excessive sedation is a "serious safety concern" with an experimental, long-acting form of Eli Lilly and Co's blockbuster Zyprexa schizophrenia medicine, U.S. drug reviewers said in an analysis released on Monday.
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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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The US Food and Drug Administration yesterday sought to distance itself from remarks by one of its top safety officials that raised concerns about key drugs made by Astrazeneca and Glaxo Smithkline.
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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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Eli Lilly and Co. has downplayed for about 10 years the risks associated with Zyprexa, which treats schizophrenia, The New York Times said on its Web site Sunday, citing internal documents from the drug maker and e-mail messages of its managers.
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WASHINGTON - About two-thirds of Food and Drug Administration scientists are less than fully confident in the agency&#39;s monitoring of the safety of prescription drugs now being sold, according to an FDA internal survey.
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New reports suggest another drug company moved too slowly to pull a dangerous medication from the market and question the Food and Drug Administration&#39;s ability to protect the public.
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WASHINGTON Nov 5, 2004 - Buffeted by criticism, the Food and Drug Administration said Friday that it would appoint a director of drug safety and take other steps to improve the safety of medications.
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Eli Lilly and Co. said Friday it added a warning to the label of its attention deficit/hyperactivity disorder medicine, advising patients with jaundice or a liver injury to stop taking the treatment.
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US Food and Drug Administration staff reviewers on Tuesday questioned clinical data for non-Hodgkin&#39;s lymphoma drug Marqibo, made by Inex Pharmaceuticals Corp.
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A top Republican lawmaker raised concerns about the U.S. Food and Drug Administration's ability to monitor drug safety following Merck & Co. Inc.'s recall of its arthritis drug last week, according to a letter made public on Tuesday.
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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 top Republican lawmaker raised  concerns about the U.S. Food and Drug Administration's ability  to monitor drug safety following Merck & Co. Inc.'s recall of  its arthritis drug last week, according to a letter made public  on Tuesday.
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ROCKVILLE, Md.  - The U.S. Food and Drug  Administration will ask the Institute of Medicine to study the  agency's safety monitoring of medicines already on the market,  Acting FDA Commissioner Lester Crawford said on Friday.
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NEW YORK -- Eli Lilly and Co. has downplayed for about 10 years the risks associated with Zyprexa, which treats schizophrenia, The New York Times said on its website yesterday, citing internal documents from the drug maker and e-mail messages of its managers.
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A top Republican lawmaker raised concerns about the US Food and Drug Administration&#39;s ability to monitor drug safety following Merck &amp; Co.
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WASHINGTON  - A group of physicians and  families called on US regulators Tuesday to warn the public  about a rare but potentially fatal set of skin reactions linked  to taking the painkiller ibuprofen.