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FDA Warns on Red Yeast Rice

Mar 7, 2008 | Parker Waichman LLP

Red yeast rice, a popular cholesterol-lowering dietary supplement could carry some serious health risks. The US Food and Drug Administration (FDA) has issued a warning that some brands of red yeast rice supplements may contain a prescription medication that could be harmful to your health.  Red yeast rice has been advertised as a popular dietary supplement that can be used in the treatment of high cholesterol.  And while there is some evidence that red yeast rice can, in fact, help lower the bad–or LDL—cholesterol, the FDA has issued a warning that the following red yeast rice products could contain a prescription medication known as lovastatin and should not be used:

  •     Red Yeast Rice sold by Swanson Health Products Inc. and manufactured by Nature's Value Inc. and Kabco Inc.
  •     Red Yeast Rice/Policosanol Complex also sold by Swanson Health Products Inc. and manufactured by Nature's Value Inc. and Kabco Inc.
  •     Cholestrix, sold by Sunburst Biorganics.


Lovastatin is a type of cholesterol-lowering drug known as a statin that is also available generically.
The FDA is concerned about these specific lovastatin-containing supplements because lovastatin is the active ingredient in Mevacor, a prescription drug sold in the United States as a treatment for high cholesterol. 
The presence of lovastatin in these three red yeast rice products is potentially dangerous because there's no way for someone consuming the products to know what level or quality of lovastatin might be in the red yeast rice.  Lovastatin is known to dangerously interact with other medications and, on its own, Lovastatin can cause other serious health problems.  Lovastatin is a prescription-only medication that should only ever be used by patients under the advice of their physician and with a prescription.

Lovastatin can also cause severe muscle problems that could result in kidney damage. This risk is especially true if higher doses of lovastatin are taken or if lovastatin is combined with other medications that can also create greater susceptibility to muscle problems.  Lovastatin can also interact dangerously with medications such as the antidepressant nefazodone, certain antibiotics, drugs used to treat fungus infections, drugs used to treat HIV infections, as well as other cholesterol-lowering drugs.

The FDA has ordered the makers of the red yeast rice products in question to stop marketing the supplements.  Consumers are also being advised to stop taking a red yeast rice supplement if it's one of these three types:  Red Yeast Rice sold by Swanson Health Products Inc. and manufactured by Nature's Value Inc. and Kabco Inc., Red Yeast Rice/Policosanol Complex also sold by Swanson Health Products Inc. and manufactured by Nature's Value Inc. and Kabco Inc., and Cholestrix, sold by Sunburst Biorganics.

These products are often advertised and sold on the Internet.  Consumers are also advised to visit their health care providers if they notice any problems they think might be related to taking these red rice yeast supplements such as unexplained muscle pain.  Generally, consumers are advised to discuss with their health care provider if they are taking any red yeast rice product.


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