Sale of Drug to Cut Cholesterol Approved

The Food and Drug Administration on Tuesday authorized the sale of a cholesterol-lowering drug that could help millions of people reduce their risk of heart attacks and strokes.

The prescription drug, taken as a tablet once or twice a day, is called lovastatin and will be available in two or three weeks under the brand name Mevacor. It will be marketed by Merck Sharp & Dohme of West Point, Pa.

Dr. Michael Brown and Dr. Joseph Golstein, University of Texas cholesterol researchers who shared the 1985 Nobel prize in medicine, hailed lovastatin as the first in a class of drugs whose discovery drew on their research on the body’s natural production and processing of cholesterol.

The FDA said lovastatin may be particularly useful for patients having high levels of the fatty, waxlike substance that can clog arteries and set the stage for heart attacks and strokes. An estimated 400,000 Americans have a hereditary predisposition to high cholesterol that cannot be controlled through diet.

“The drug may prove a useful addition in the fight against coronary heart disease, our No. 1 cause of death,” FDA Commissioner Frank E. Young said. “High cholesterol, along with cigarette smoking and high blood pressure, is a primary factor predisposing Americans to heart disease.”

At a news conference, company spokesmen stressed that lovastatin should be used only when diet and exercise have failed to reduce cholesterol. Merck said the drug should not be used by children or pregnant women and should be given to women of childbearing age only when they are highly unlikely to become pregnant.

Some patients in studies that led to the FDA approval had liver problems and others had opaque spots on their eye lenses. The agency said that these problems might have been related to the drug and that patients receiving lovastatin should have a blood test for liver function every six weeks and an eye test annually.

Lovastatin works by inhibiting the enzyme that governs an essential step in the liver’s manufacture of cholesterol, which is essential to health at moderate levels.

Despite the drug’s effectiveness in lowering cholesterol, the FDA said studies to see whether lovastatin will reduce the risk of coronary heart disease or overall mortality have not been completed.