Over-the-counter sales of Mevacor to be evaluated by the FDA again

C. Michael Gibson, M.S., M.D. December 10, 2007

Washington DC: an FDA advisory panel will be convened on Thursday to consider whether Mevacor should be available to consumers over the counter. This is the third time that Merck has sought FDA approval to sell Mevacor, also known under the brand name of lovastatin over-the-counter.

Prior attempts to garner approval by the FDA failed in 2000 and 2005. The advisory panel at that time recommended that the drug not be approved for over-the-counter sales. Currently Mevacor as well as all of the stations are only available by prescription from a licensed physician.

While many patients currently are treated with the Statin, there are estimates that up to 14 million patients United States who are at risk for heart disease are not on a statin. The goal would be to increase the penetrance of this drug in that group of patients.

Advisers to the FDA had in the past expressed concern that patients cannot adequately weigh the risk and benefits from taking such a medication. One additional concern is the potential exposure of women aged 45 to 55 who may be of childbearing potential.