Merck's Cholesterol Drug Mevacor May Sell Over The Counter

Merck & Co.'s Inc.'s cholesterol-lowering drug Mevacor would benefit patients who take it properly over the counter, but an advisory panel should weigh the risks if people take higher-than-recommended doses, U.S. regulatory staff said in documents released on Wednesday. Data "support the conclusion that risks of muscle and (liver) toxicity are rare events that do not offset the benefits associated with long-term use" of an over-the-counter dose of Mevacor in otherwise healthy patients, Food and Drug Administration reviewers said in documents posted on the FDA's Web site. The FDA staff will ask an advisory panel that meets Thursday and Friday to consider the risks if people take higher doses, and if the potential dangers to a pregnant woman's fetus are acceptable for a nonprescription drug, the documents said. Benefits if the drug were taken short-term or occasionally are unknown, the FDA staff said. Mevacor is part of a family of medicines called statins that millions of people take by prescription to reduce the risk of heart disease. Merck wants to sell a 20-milligram dose of the drug without a prescription for people at moderate risk of heart disease.