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FDA Issues Warning on Red Yeast Rice Products

Touted as treatment for high cholesterol, they may contain lovastatin

FRIDAY, Aug. 10 (HealthDay News) -- The U.S. Food and Drug Administration has issued a warning on the potentially harmful effects of three red yeast rice products that are being sold via the Internet as a treatment for high cholesterol. The products were found to contain lovastatin, the active ingredient in the prescription cholesterol-lowering drug Mevacor.

The three products are Red Yeast Rice, manufactured by Nature's Value, Inc., Red Yeast Rice/Policosonal Complex manufactured by Kabco Inc. (both of which are sold by Swanson Healthcare Products, Inc.), and Cholestrix, sold by Sunburst Biorganics. Swanson and Sunburst Biorganics have been warned by the FDA to stop selling the products because they are unapproved new drugs.

Lovastatin can cause kidney impairment in patients who experience adverse muscle reactions. Patients who take too much of the drug, or other medications, are at higher risk, including those taking the antidepressant nefadozone and certain antibiotics.

"This risk is even more serious because consumers may not know the side effects associated with lovastatin and the fact that it can adversely interact with other medications," said Steven Galson, M.D., director of FDA's Center for Drug Evaluation and Research, in a statement.

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