FDA Advisers Again Oppose Over-the-Counter Sale of Lovastatin (Mevacor)

Peggy Peck
SILVER SPRING, Md., Dec. 14 -- An FDA advisory panel has overwhelmingly rejected a third request to allow lovastatin (Mevacor) to be sold without a prescription.
The advisers' vote was 10 to 2 against recommending over-the-counter status for the statin in a 20-mg version.
The FDA is not required to follow recommendations from its advisory panels, but it usually does. Following the meeting, Merck said it expected an FDA decision by Jan. 26.
The American Medical Association, a group that rarely weighs in on FDA actions, openly opposed the concept of OTC sales for lovastatin. The AMA cited statin side effects ranging from muscle pain to rhabdomyolysis and argued that statin use requires close monitoring by physicians.
Panel member Sonia Caprio, M.D., of Yale, said she was concerned about use of the drug by people who didn't need it. If lovastatin were available on drug store shelves, "there is going to be abuse," she said.
Edwin L. Hemwall, of Merck Research Laboratories, said in a statement that the company believed that permitting OTC sales of lovastatin would "be a valuable option for motivated consumers who know they have moderately elevated cholesterol and certain risk factors, and are already talking with their health care provider."