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FDA Advisers Reject Over-the-Counter Statin

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For the third time in seven years, U.S. Food and Drug Administration advisers have voted to deny Merck & Co.'s request to make the cholesterol-lowering drug Mevacor available over the counter.

In a 10 to 2 vote with one abstention, the FDA advisers said Thursday that it would be too complicated for consumers to determine on their own if they were a good candidate for the drug, part of a class of medications called statins.

"The general consensus is that these are safe medications, but the concerns were whether consumers could make an informed decision," said Dr. Mary Tinetti, chairwoman of the FDA's Nonprescription Drugs Advisory Committee. "We need to see more real world experience with consumer decision-making," Tinetti said.

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