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Red Yeast Rice: Buyer Beware

I have had increasing numbers of patients who come to me who are using Red Yeast Rice (RYR) as the only means to treat their high cholesterol. Many people make the assumption that this is a “natural medicine” and that it is

completely safe to use and actually works. Unfortunately, RYR is not the wonder

drug that many folks think that it is and may actually be harmful as I will explain.

One must remember that in 2008, there were many products manufactured in

China that were found to be tainted with lead and melamine, to name a few of


Red Yeast Rice extract is the fermented product of rice on which red yeast has

been grown . The active ingredient in red yeast rice is believed to be Monacolin

K, an agent reported to be identical to lovastatin (a commonly prescribed statin).

Like statins, red yeast has been found to directly reduce lipids. There is little

doubt that the proprietary preparation of red yeast rice, known as Cholestin

favorably alters lipids. However, due to legal issues, this preparation is no longer

commercially available in the US. In 1998, the FDA determined that red yeast

rice did not conform to the definition of a dietary supplement under the 1994 Diet

supplement and Health Education Act (DSHEA). This act states that marketed

dietary supplements cannot contain a compound already approved as a drug (in

this case, lovastatin) unless the substance was available commercially before the

drug's approval. At present, Cholestin is still available in Canada, Europe and

Asia – however, great caution should be exercised because Cholestin has been

reformulated and no longer contains the important Red Yeast Rice extract, but

rather polymethoxylated flavones extracted from citrus fruits, geraniol and marine

fish oils. It is unclear if this or other proprietary preparations of red yeast extract

will provide the same lipid effects. The FDA has issued a warning to consumers

regarding three brands of red yeast rice. Follow this link for more information. and type in red yeast rice in the search box.

As a result of a study published in the June 15, 2008 issue of the American

Journal of Cardiology, the National Lipid Association felt compelled to write an

official statement on this RYR study. This study suggested that a new ingredient

of RYR, called Xuezhikang (XZK), may have significant benefits. The published

study was a randomized, double-blind, placebo study conducted in Chinese

hospitals on 4,870 patients who had a previous heart attack within the past 5

years. The primary endpoint was the occurrence of a major coronary event or

death from coronary or cardiac causes. The striking findings of this study are the

45% reduction of the relative risk of major coronary events and the statistically

significant reductions in CV and total mortality The NLA recommended that

physicians and patients should beware that the composition of this product is not

yet known and any future use will depend on the results of ungoing studies.

XZK is produced by the Beijing WBL Peking University Biotech Co. Ltd and is the

purified extract of Chinese RYR with multiple components. This product is not

sold in the USA, lacks FDA approval, and is not identical to other products sold in

the USA as “red yeast rice”. This does not mean that this particular brand is not

brought into this country illegally. Like the product known as Cholestin, XZK

contains lovastatin, plants sterols, and isoflavones. At the present time, it is not

known to what extent, if any, lipid- lowering accounts for treatment benefit.

To summarize the current thought on this preparation and all other types of RYR,

1. Physicians should not advise patients to take any RYR supplement as

efficacy has not been proven for any indication.

2. If you are taking a medicine for cholesterol management, continue to take

your prescripton. Do NOT add any RYR to your current medications as

adverse effects may be more likely.

3. RYR should not be substituted for statins. The active ingredients of any of

the preparations currently sold in the USA are unknown

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