FDA: Lovastatin Should Remain a Prescription Medication
For the third time in seven years, FDA turns down Merck's OTC-switch application for lovastatin
FRIDAY, Dec. 14 (HealthDay News) -- By a 10-2 vote with one abstention, a joint U.S. Food and Drug Administration (FDA) Nonprescription Drugs and Endocrinologic and Metabolic Advisory Committee recommended Dec. 13 against accepting Merck & Co.'s proposal to switch its cholesterol-lowering drug lovastatin (Mevacor) from a prescription to an over-the-counter (OTC) medication. It's the third time that an FDA committee has turned down Merck's OTC-switch application for lovastatin.
Before the committee made its non-binding decision, members evaluated a social science review of the application conducted by the Office of Nonprescription Products which evaluated two Merck studies: a label comprehension study and a separate muscle warning study. Members also considered testimony from groups opposing Merck's proposal, including the American Medical Association, Public Citizen and Consumers Union.
According to the social science review, many study participants demonstrated high levels of label comprehension in areas such as the indication, the contraindications and the importance of reducing the amount of cholesterol in the diet before starting lovastatin. But they had difficulty understanding label instructions explaining who and who should not use lovastatin based on cholesterol numbers and other risk factors.
"The general consensus is that these are safe medications, but the concerns were whether consumers could make an informed decision," said Mary Tinetti, M.D., chairwoman of the FDA's Nonprescription Drugs Advisory Committee. "We need to see more real world experience with consumer decision-making."