BEIJING, Dec. 14 (Xinhuanet) -- An advisory panel of U.S. Food and Drug Administration has rejected a request from Merk & Co. of over-the-counter use of its cholesterol-lowering drug Mevacor, media reports said Friday.

    FDA declined the request believing that patients cannot easily make the proper medical decisions without a doctor's supervision and obtaining a prescription.

    This was a major setback in Merck & Co's years-long effort to sell Mevacor over the counter.

    Ten committee members voted against allowing use without a prescription, two favored the switch to OTC and one abstained. A majority said the drug was generally safe, but expressed concerns that some consumers cannot might take too low a dose for their needs while other might take it when it was not needed.

    "I think (Mevacor) is safe and effective but I don't think it's an over-the-counter drug," said Richard Neill, a panel member and an assistant professor at the University of Pennsylvania School of Medicine.

    The FDA ruled against a similar request in 2005, stating that the company had not demonstrated that average consumers could safely and effectively use the drug.

    Mevacor is a prescription medicine that is approved in the U.S. for the treatment of elevated cholesterol levels that lifestyle changes alone cannot control and to reduce the risk of a first heart attack, unstable angina and coronary revascularization procedures in healthy men and women with average or moderately elevated cholesterol levels.

    According to the prescribing information, Mevacor should not be used by anyone allergic to any of its components, people with liver disease, or by women who are pregnant, breast-feeding, or likely to become pregnant. It is recommended that liver function tests be performed in all patients prior to daily use of Mevacor 40 mg or more.

    (Agencies)