|
E-mail this page to a friend!
Senior Citizen Alerts
Seniors Warned to Avoid Red Yeast Rice Sold Online
to Treat High Cholesterol
FDA says tested products contain unauthorized drug,
lovastatin
 Aug. 10, 2007 The millions of senior citizens
battling against high cholesterol are warned by the Food and Drug
Administration to stay away from three red yeast rice products promoted
and sold on Websites as dietary supplements for treating high
cholesterol. The products may contain an unauthorized drug, lovastatin,
that could be harmful to health.
The potentially harmful products are: Red Yeast
Rice and Red Yeast Rice/Policosonal Complex, sold by Swanson Healthcare
Products, Inc. and manufactured by Natures 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 firms websites, are unapproved new drugs that are marketed in
violation of the Federal Food, Drug, and Cosmetic Act. The warning
letters are available on FDAs 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 FDAs 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.
Click to More Senior News on the
Front Page
Copyright: SeniorJournal.com |
