Mevacor is one of the oldest statins, or cholesterol-lowering medications. It's been proven to effectively reduce the risk of heart disease.
But because many people with high cholesterol do not take any cholesterol medication, the makers of Mevacor wanted to sell their low-dose form without a prescription. They say this way more people would get the treatment they need.
But the F.D.A. voted against the request Friday. They say high cholesterol has to be monitored by a physician. The advising council also said the risks of putting the drug over-the-counter do not outweigh the benefits. There is a risk of birth defects for women who are pregnant and taking the drug. There is also a risk of liver toxicity in all patients on Mevacor.