FDA Warning - Red Yeast and Statins

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http://www.fda.gov/bbs/topics/NEWS/2007/NEW01678.html

FDA News

FOR IMMEDIATE RELEASE

August 9, 2007

Media Inquiries:

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 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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Carl Grimes

Healthy Habitats LLC