Article: Nonprescription Sales of Cholesterol Drug Rejected; FDA Panel Says Risk of Side Effects Outweighs Benefits

Federal advisers yesterday rejected a proposal to allow the sale of a powerful cholesterol-lowering pill without a prescription, saying the risk of side effects outweighed the possible benefits of preventing more heart attacks and strokes.

At the conclusion of an unusual joint meeting of two Food and Drug Administration expert committees, the panel voted 20 to 3 that the agency should deny a request from Merck & Co. and Johnson & Johnson to market a low-dose version of Merck's drug Mevacor to consumers without a doctor's order.

Although many members said they endorsed the general idea of increasing the use of cholesterol drugs called statins by making them more easily available, they said ...

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