Over-the-counter cholesterol pills rejected
Published 9:00 pm Friday, January 14, 2005
WASHINGTON – Federal advisers on Friday 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 experts 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.
While many panel members said they endorsed the general idea of increasing the use of cholesterol drugs called statins by making them more easily available, they said the proposal failed to do enough to ensure that only the right patients take the drug and are then closely monitored. Specifically, the advisers were concerned pregnant women might take the drug, resulting in birth defects, and that patients might suffer rare but potentially life-threatening liver and muscle complications.
Several panel members said they would have preferred a plan that allowed the drug to be sold without a prescription, but only after consulting a pharmacist. A similar scheme was recently approved in Britain for a cholesterol drug.
The FDA will make the final decision on the Mevacor proposal, but the agency usually follows the advice of its advisers. The FDA rejected a similar request from Merck four years ago.
Research has clearly established that statins can sharply reduce the risk of heart attacks and strokes, primarily by lowering levels of so-called “bad,” or LDL, cholesterol. While the drugs can produce life-threatening liver and muscle problems, they are generally considered safe.
