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news.Merck & Co's proposal for over-the-counter sales of its cholesterol-lowering statin, Mevacor, has been voted against by an FDA advisory panel, according to reports.
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Mevacor inhibits an early step in the lead-up to cholesterol, the conversion of HMG-CoA to mevalonate.
The Mevacor (lovastatin) proposal, submitted for review by Merck and Johnson and Johnson, is rumored to have failed to receive the FDA panel’s positive recommendation due to concerns over consumers’ abilities to safely monitor their intake of the drug.
The panel has seemingly expressed concerns that patients outside the drug’s indication groups, such as pregnant or nursing women and people with low heart disease risk, might take the drug and unnecessarily expose themselves to the risk of side effects. Mevacor’s side effects include muscle pain and muscle cell damage and kidney failure.
The panel has, however, left open the possibility for Mevacor to be sold over-the-counter in the future, according to press reports.