Panel Urges FDA Not to Approve Weight-Loss Drug
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An advisory panel of experts recommended unanimously yesterday that the Food and Drug Administration reject a new weight-loss drug after hearing testimony that it increases the risk of suicidal behavior.
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U.S. regulators have rejected  GlaxoSmithKline Plc's  experimental drug gepirone ER for  adults with major depression.
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U.S. health officials Thursday called on doctors to limit prescribing Pfizer Inc. painkillers Celebrex and Bextra in light of recent evidence that they may increase the risk of heart attack and stroke.
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Federal advisers are considering whether a proposed weight-loss drug raises the risk of depression, a finding that could lead to stern warnings on the medication if it is approved.
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A U.S. advisory panel  urged the government on Thursday to reject Merck & Co Inc's   latest bid to sell the first cholesterol-lowering drug  without a prescription.
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The US Food and Drug Administration asked David Graham, who last month told a Senate committee that the agency fails to protect the public from dangerous medicines, to leave his position
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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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GAITHERSBURG, Maryland  - The Food and Drug Administration should consider telling patients and doctors that the use of drug-coated heart stents in unapproved, high-risk cases can lead to greater complications, a panel of medical experts said on Friday.
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A weight-loss drug used by thousands is unsafe for those also taking antidepressants, health watchdogs warn.
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WASHINGTON -- The Food and Drug Administration warned consumers yesterday not to buy or use the supplements Actra-Rx or Yilishen because they contain an ingredient that could lower blood pressure to unsafe levels.
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U.S. health officials and drugmaker GlaxoSmithKline Plc are likely to face tough questioning from lawmakers on Wednesday over their handling of data suggesting a heart risk with the widely used diabetes pill Avandia.
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The panel said that while Americans could benefit from taking a Merck cholesterol-lowering drug, they should not begin such a regimen without a doctor's advice.
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BETHESDA, Md.  - A U.S. advisory panel on Friday  urged regulators to reject over-the-counter sales of Merck &  Co. Inc.'s MRK.N cholesterol-lowering drug Mevacor.
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The chairman of a House committee angrily accused the Food and Drug Administration on Thursday of withholding documents on the effects of antidepressants on children.
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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 acting Food and Drug Administration (FDA) commissioner on Monday disputed a published report that said agency officials knew before Oct. 5 that British health authorities might suspend
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An advisory panel&#39;s recommendation that the Food and Drug Administration require antidepressant medicines to carry warnings about the possible risk of suicidal behavior in children taking the drugs is a prudent move.