FDA panel rejects OTC request for Mevacor
The panel also voiced concern that women who are pregnant, and may not know it, will wind up taking Mevacor and possibly damage the developing fetus.
The vote was 20-3.
Advisers expressed concern that in studies simulating over-the-counter sales, most of the people who opted to take Mevacor didn't meet the requirements of the label. Some people were not at high enough risk of heart disease to need the drug, for instance, or their cholesterol levels weren't high enough. In other cases, their risk of heart disease was so high that they should be seeing a doctor and possibly receiving a stronger drug.