During the last several years, red yeast rice, an Asian dietary staple made by fermenting red yeast (Monascus purpureus) on rice, gained rapid recognition in the United States as a cholesterol-lowering agent. This was because a careful fermentation process yielded specific amounts of statins--the compounds largely held responsible for reducing cholesterol levels. In 2001, however, red yeast rice extract, a "natural" unregulated nutritional supplement, was withdrawn by the FDA. This decision followed the agency's determination that it was chemically too similar to the prescription statin medication Mevacor, and thus should be classified as a "drug," which by law is strictly controlled by the federal government.

As a result, supplements containing red yeast rice have basically disappeared from retail stores. And the original product, Cholestin, has been reformulated without red yeast rice. It's likely, however, that sources of red yeast rice may still remain available on the Internet. If the product does return to health-food stores in the future, it will probably be available only by a doctor's prescription.

As a substance, red yeast rice extract has a number of heart-healthy benefits: It seems to help reduce total cholesterol levels, lower levels of LDL ("bad") cholesterol, increase levels of HDL ("good") cholesterol, and lower levels of unhealthy fats called triglycerides. It appears to accomplish this by restricting the liver's production of cholesterol. The compound responsible for this effect--mevinolin--is chemically identical to the cholesterol-lowering compound lovastatin, which is sold as the prescription drug Mevacor. Hence the action by the FDA. Mevinolin is also similar to the active ingredients in other cholesterol medications such as Zocor (simvastatin) and Lipitor (atorvastatin). Unsaturated fatty acids in red yeast rice extract are also believed to be beneficial, possibly by lowering triglycerides.

By lowering cholesterol concentrations, red yeast rice extract may help to prevent heart disease and some of its complications. Individuals with moderately elevated cholesterol levels (200 to 239 mg/dL) may benefit from a dietary supplement such as red yeast rice extract. However, those with very high cholesterol levels (240 mg/dL or above) are at considerable risk for heart disease and should stick to prescription drugs with a proven ability to rapidly and effectively reduce cholesterol levels.

The best way to achieve and maintain a healthy cholesterol level is to take heart-healthy substances such as red yeast rice extract as part of an overall regimen that includes exercise and a low-fat diet that is high in soluble fiber. Most studies of the extract that showed a substantial cholesterol-lowering effect (reduction of 25 to 40 points) included such lifestyle measures.

If you choose to incorporate red yeast rice into your cholesterol-lowering program, it is very important to remember that you are taking a substance that acts identically in the body to the prescription statin drugs. This means that red yeast rice can cause the same side effects (mild gastrointestinal upset and possible changes in liver enzymes, or a muscle condition called rhabdomyolysis). Research studies have shown red yeast rice to be remarkably safe, but of course, you should not use it if you are also taking a prescription statin.

Because of the FDA withdrawal of red yeast rice, its distributors, NuSkin International, chose to reformulate its product Cholestin by replacing the red yeast rice with other substances, namely plant sterols and stanols and policosanol, which is derived from beeswax and sugar cane. These new ingredients will still positively affect your cholesterol profile, even though red yeast rice is no longer an ingredient of Cholestin. Likewise, NuSkin no longer licenses red yeast rice to other supplement manufacturers, so other products that also once contained red yeast rice no longer do.

 

There are no known drug or nutrient interactions associated with red yeast rice. However, there are interactions associated with lovastatin. Prescription statin drugs such as lovastatin can reduce levels of coenzyme Q10, an antioxidant produced by the heart and other tissues to protect cells from damage. Some experts recommend supplementing a regimen of red yeast extract (or other statin drugs) with this nutrient.

 

Don't mix red yeast rice extract with other statin-type cholesterol-lowering medications, or you may risk consuming excessive amounts of particular ingredients. However, red yeast rice can be safely combined with niacin supplements for additional cholesterol-lowering effects.

Cautions

 

Consult your doctor before taking red yeast rice or any other cholesterol-lowering dietary supplement. This is particularly important if you have high cholesterol or heart disease; conventional medicines have been proven to rapidly and effectively lower cholesterol levels, directly lowering your heart attack risk.

 

Take red yeast rice extract with food to reduce the risk of digestive upset.

 

Side effects with red yeast rice extract have been reported but tend to be mild and resolve quickly once you stop taking it. These include headache, dizziness, heartburn, gas, and digestive tract discomfort. Stop taking red yeast rice extract and consult a doctor promptly if you experience any side effects that seem more severe or persistent than these.

 

Keep in mind that, in theory, the statins in red yeast rice extract pose the risk of rare but serious reactions, including skeletal muscle damage, liver damage, and kidney toxicity. Approximately 1% to 2% of people taking the drug lovastatin have such reactions. Symptoms may include unexplained weakness, muscle pains and tenderness, and other flu-like symptoms. It's still unclear whether these types of reactions occur with people taking standardized red yeast rice extract, however. In a recent, 12-week clinical trial, for example, liver and kidney function in the participants remained normal.

 

More information on possible side effects should become available as results of studies on red yeast rice extract are completed in the coming years.

 

To avoid possible complications due to the statin content in red yeast rice extract, don't take this supplement if you are pregnant or breast-feeding, or if you have liver disease, a serious infection, or a transplanted organ. Also avoid it if you have recently had major surgery.

 

Don't take red yeast rice extract if you are younger than age 20.

 

Avoid drinking more than two alcoholic drinks a day or large amounts of grapefruit juice while taking red yeast rice extract.

Ailments	Dosage
High Cholesterol	Take 2 pills (600 mg each) twice a day. Also take 50 mg coenzyme Q10 twice a day.