Advisers deny OTC cholesterol drug sales

? Federal health advisers recommended against over-the-counter sales of a cholesterol drug Friday, saying patients need medical guidance for treatment of a chronic condition that has no symptoms and could require drugs for life.

The safety of Mevacor is well-established, but advisers worried that the wrong people might take it if it sat on open drugstore shelves, particularly after a probable aggressive advertising campaign to sell it.

The vote on the advisory committee was 20-3.

Advisers expressed misgivings because studies that simulated over-the-counter sales indicated that 90 percent of people who took Mevacor didn’t meet the requirements of the label.

Some people were too young or not sick enough to need it. In other cases, the risk of heart disease was so high that the patients should have seen a doctor and received a stronger drug.

The panel advising the Food and Drug Administration also voiced concern that women who were pregnant and did not know it would take Mevacor and possibly damage the developing fetus.

Supporters argued that making Mevacor more easily available would help get needed treatment to millions of Americans at moderate risk of heart disease who needed to lower cholesterol levels but were not taking helpful drugs.

And several advisers said they liked the idea of wider availability of statins like Mevacor, which lower cholesterol by limiting the buildup of artery-clogging fat deposits and reduce risk of heart attack by about a third.