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FOR IMMEDIATE RELEASE
August 9, 2007
Media Inquiries:
Catherine McDermott, 301-827-6242
Consumer Inquiries:
888-INFO-FDA
FDA Warns Consumers to Avoid Red Yeast Rice Products Promoted on
Internet as Treatments for High Cholesterol
Products found to contain unauthorized drug
The U.S. Food and Drug Administration is warning consumers not to buy or
eat three red yeast rice products promoted and sold on Web sites. The
products may contain an unauthorized drug that could be harmful to
health. The products are promoted as dietary supplements for treating
high cholesterol.
The potentially harmful products are: 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. FDA testing revealed the
products contain lovastatin, the active pharmaceutical ingredient in
Mevacor, a prescription drug approved for marketing in the United States
as a treatment for high cholesterol.
"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., M.P.H.,
director of FDA's Center for Drug Evaluation and Research.
These red yeast rice products are a threat to health because the
possibility exists that lovastatin can cause severe muscle problems
leading to kidney impairment. This risk is greater in patients who take
higher doses of lovastatin or who take lovastatin and other medicines
that increase the risk of muscle adverse reactions. These medicines
include the antidepressant nefazodone, certain antibiotics, drugs used
to treat fungal infections and HIV infections, and other
cholesterol-lowering medications.
FDA has issued warning letters advising Swanson and Sunburst Biorganics
to stop promoting and selling the products. Companies that do not
resolve violations in FDA warning letters risk enforcement actions, such
as an injunction against continuing violations and a seizure of illegal
products.
The FDA warning letters state that the products Red Yeast Rice, Red
Yeast Rice/Policosonal Complex, and Cholestrix, sold on the firm's
websites, are unapproved new drugs that are marketed in violation of the
Federal Food, Drug, and Cosmetic Act. The warning letters are available
on FDA's Web site: www.accessdata.fda.gov/scripts/wlcfm/recentfiles.cfm.
FDA advises consumers who use any red yeast rice product to consult
their health care provider if they experience problems that may be due
to the product.
Report adverse events related to these products to MedWatch, the FDA's
voluntary reporting program:
www.fda.gov/medwatch/report.htm; 800-332-1088; Fax: 800-332-0178; and
MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville,
MD, 20852-9787.
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