FDA Warns Against Use of Red Yeast Rice Supplements

ROCKVILLE, Md., Aug. 10 -- The FDA has warned consumers against using three brands of red yeast rice, a product marketed as a natural remedy for high cholesterol, because they may contain lovastatin, the active ingredient in Mevacor.

The products, marketed in stores or on the Web, are Red Yeast Rice and Red Yeast Rice/Policosonal Complex, sold by Swanson Healthcare Products, and manufactured by Nature's Value. and Kabco, respectively; and Cholestrix, sold by Sunburst Biorganics.

FDA investigators conducting routine testing of the supplement detected lovastatin, which was the first statin approved by the FDA. It has been available as a generic drug since 2002.

Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research, said consumers may be unaware of side effects associated with lovastatin. These include rhabdomyolysis, especially when lovastatin is combined with the antidepressant nefazodone, certain antibiotics, drugs for fungal infections and HIV infections, and other cholesterol-lowering medications.

The FDA recommended that consumers who use any red yeast rice product obtain medical advice if they have muscle pain or other problems that may be associated with the red yeast.

The agency issued warning letters advising Swanson and Sunburst Biorganics to stop promoting and selling the products.

The FDA's warning letters said that the products Red Yeast Rice, Red Yeast Rice/Policosonal Complex, and Cholestrix represent unapproved new drugs that are marketed in violation of the Federal Food, Drug, and Cosmetic Act.