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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.
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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.
[Text copied
from U.S. Food and Drug Administration
news release]
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