F.D.A. Panel Rejects Over-the-Counter Cholesterol Drug
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Government advisers rejected Merckâs bid for over-the-counter sales of a cholesterol-lowering drug, saying that too many people would mistakenly use the drug if it no longer required a prescription.
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SILVER SPRING, Maryland  - Making a cholesterol drug available over the counter could give millions of Americans a new option to reduce the risk of heart disease and provide a major public health benefit, drugmaker Merck & Co Inc argued to a U.S. advisory panel on Thursday.
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A popular cholesterol-lowering drug failed to help slow the buildup of artery-clogging plaque in a long-awaited study, the companies that market the medication said yesterday, raising questions about whether its use should be limited.
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New research indicates that few high-risk women are achieving the optimal cholesterol levels set forth in recent guidelines by the American Heart Association (AHA). Moreover, only about one third of eligible women are receiving cholesterol-lowering drugs.
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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 cholesterol-lowering drug Mevacor because of doubts  the medicine could be used safely without a doctor's guidance.
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Popular pediatric over-the-counter cough and cold medicines work no better than placebos, an F.D.A. panel said.
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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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Plan B, an emergency contraceptive, is under review again by the Food and Drug Administration after it previously denied over-the-counter sale of the drug. Women's groups charge the decision was political, not scientific.
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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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WASHINGTON -- The Food and Drug Administration is preventing an agency scientist from presenting the largest, most up-to-date study of popular painkillers like Bextra, Celebrex and Vioxx during an FDA meeting next week on heart risks posed by the drugs, a US senator charged.
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It's not enough to reduce "bad" cholesterol to prevent heart attacks because a substance called CRP also must be kept low, doctors said on Wednesday in a finding that could save tens of thousands of lives.
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Consumer advocates backed by some  prominent doctors and researchers on Thursday questioned a new  U.S. policy recommending wider use of statin drugs to lower  cholesterol.
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SILVER SPRING, Maryland  - U.S. regulators should reject a proposed weight-loss pill called Zimulti because of concerns it may increase suicidal thinking and depression, an advisory panel unanimously said on Wednesday.
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The F.D.A. said that it would consider whether to remove Iressa, a product from AstraZeneca, from the market after the drug failed to prolong the lives of people in a clinical trial.
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Federal health advisers recommended against over-the-counter sales of cholesterol drug Mevacor, saying that patients need medical guidance.
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U.S. regulators said on Friday they would review whether to take action over Merck & Co Inc's  and Schering-Plough Corp's  popular cholesterol medicine Vytorin after a study showed it was no better than a generic drug in preventing the build-up of fatty plaque.
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U.S. regulators said on Friday they  would review a study showing a Merck and Schering-Plough  cholesterol drug worked no better than a generic in preventing  the build-up of arterial plaque.