FDA Urging Consumers to Avoid Red Yeast Rice Products


Supplements Intended to Lower Cholesterol May Contain Harmful Drug

The U.S. Food and Drug Administration (FDA) is urging consumers to discontinue using three red yeast products promoted and sold on Web sites as dietary supplements to treat high cholesterol because they may contain the drug Mevacor (lovastatin). This prescription medication is approved in the United States for treating high cholesterol. However, lovastatin can be potentially harmful in individuals who have not been formally prescribed the drug by their physician.
Manufacturers of the following items have been ordered to discontinue promoting and selling these products:

  • Red Yeast Rice and Red Yeast Rice/Policosonal Complex, sold by Swanson Healthcare Products, Inc. and manufactured by Nature's Value, Inc., and Kabco Inc., respectively; and

  • Cholestrix, sold by Sunburst Biorganics.

    These red yeast rice products may be a threat to consumers' health because lovastatin can adversely interact with other medications an individual may be taking. In addition, lovastatin may cause severe muscle problems leading to kidney impairment, particularly in individuals who take higher doses of lovastatin or who take it with other medications that increase the risk of adverse muscle reactions. These medications may include the antidepressant nefazodone, certain antibiotics, drugs used to treat fungal infections and HIV infections, and other cholesterol-lowering medications.

    The FDA is advising all consumers to consult their health care providers if they experience problems that may be due to red yeast rice products.
    For more information, visit www.fda.gov/Medwatch.


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