Red Yeast Rice: Statin Alternative or Natural Statin

A study recently published in the Mayo Clinic Proceeding has confirmed the power of natural alternatives for cholesterol management. The study, authored by group of doctors and researchers associated with University of Pennsylvania, found that a combination of the Therapeutic Lifestyle Changes (TLC) recommended by the National Cholesterol Education Program (NCEP) of the National Institutes of Health coupled with red yeast rice and fish oil supplements led to a more substantial reduction in LDL (bad) cholesterol than did simvastatin, a statin medication sold by Merck Drug under the brand name Zocor.


The authors wrote “our study was designed to test a comprehensive and holistic approach to lipid lowering…. These results are intriguing and show a potential benefit of an alternative, or naturopathic, approach to a common medical condition, hyperlipidemia”

Statin Alternative or Natural Statin

The media reported the study as an “alternative to statins.” In reality, the choice is between a prescription, controlled statin and a natural source of statins. The active ingredient in red yeast rice supplements is a naturally occurring statin. It is chemically similar to the prescription lovastatin sold by Merck under the brand name of Mevacor. In short, red yeast rice does not represent a statin alternative, but rather a natural source of statins.

For those of us with a predisposition to natural products, this may seem like an intriguing option, but red yeast rice supplements face some important challenges. The authors of this study outlined the issues:
• In 2001, the US Food and Drug Administration determined that red yeast rice with a controlled level of the lovastatin was a drug, not a dietary supplement.
• As a result, the supplement manufacturer cannot control or test for the active compounds in red yeast rice supplement. While the chemical composition of the red yeast rice supplement used in the study was known and controlled, the composition of various products and the batch consistency between lots from the same source make recommending red yest rice supplements difficult.
• Taking red yeast rice without a physician’s supervision could also have unknown risks. The lovastatin component can cause the same side effects as any statin, and a potentially dangerous metabolite, citrinin, can form in poorly manufactured preparations.

Statin Alternative Do Exist

The American Heart Association, the American College of Cardiology, the American College of Preventive Medicine and many other health and medical organization participated in developing the NCEP recommendations. The recommendations emphasize that “many people will be able to lower their LDL enough” with lifestyle and nutritional changes alone. The NCEP reports that “if your LDL needs more lowering, you may have to take a cholesterol-lowering drug” in addition to the lifestyle changes . “However, by staying on the TLC Program, you’ll be keeping that drug at the lowest possible dose. “

The Kardea website provides an extensive amount of information about TLC. It also addresses some of the nutrients not specifically recommended by the NCEP, but widely reviewed by the medical community. The important point: before taking a statin----from a prescription or an herbal supplement---consider your alternatives.

Red Yeast Rice Supplements-Can They Still Be Effective?

FDA Consistent in Restricting Sale of Lovastatin-Natural or Synthetic

Summary: Certain types of red yeast rice naturally contain lovastatin, the same active ingredient in Merck’s prescription statin medication Mevacor. Whether natural or synthetic, the FDA has consistently maintained that lovastatin has serious potential side effects and should remain a controlled (prescription) medication. As such, the FDA denied Merck’s multiple petitions to sell low-dose Mevacor on an over-the-counter basis. The FDA also has placed restrictions on red yeast rice supplements with verified levels of the naturally-occurring statin. For those interested in natural alternatives, certain nutrients, notably plant sterols, soluble fiber from oats, barley, beans, psyllium and fruit, Omega-3’s from marine sources, niacin, and monounsaturated fats replacing saturated fats, should be considered as an effective alternative approach.

Red Yeast Rice: A Particular Type is a Natural Statin

Red yeast rice is the product of yeast grown on rice. As a food, red yeast rice can be found as a paste, whole dried grains, or as a ground powder. In these forms, it has been a common food in certain Asian diets. In its traditional forms, red yeast rice contains no more than trace amounts of the active cholesterol-lowering agent. In fact, some types of red yeast rice contain no actives.

As a supplement, a particular type of enhanced red yeast rice was shown to significantly lower total cholesterol and LDL (bad) cholesterol. The active ingredient has been identified as lovastatin, the same as found in the popular statin drug, Mevacor and its generic equivalents.

Lovastatin, in turn, is a controlled prescription medication.

Can red yeast rice supplements offer benefit in comparison with prescribed statin medications?

For those preferring naturally-derived solutions, red yeast rice sources of statins could be preferred. This conceptually would be equivalent to a naturally-derived vitamin E as opposed to a synthetic. As we have further come to understand, the active agents in a natural product may be more bioavailable or more effective due to other compounds that accompany whole food. Yet, the FDA consistently views statins--natural or synthetic-- as powerful medication with potential side-effects and potential drug interactions. As such the FDA restricts the sale lovastatin, regardless of its source.

Most recently, the FDA rejected the petition of pharmaceutical giant Merck to offer Mevacor without a prescription. Merck has made three tries to have this statin sold over the counter. In rejecting Merck’s latest petition, the FDA indicated that too many of the wrong people would use the drug if it no longer required a prescription.

Last summer, the FDA issued warnings to consumers not to buy or eat certain red yeast rice products. FDA testing revealed the products contained lovastatin.

The FDA stated that “these red yeast rice products are a threat to health because 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.”


What’s in Red Yeast Rice Supplements Today?

Back in 1999, when the clinical studies on the efficacy of red yeast rice were first released, supplements with identified and controlled levels of the active compounds could be purchased. Today, however, such supplements cannot be produced. In fact, red yeast rice supplements may be made from the varieties of red yeast rice that does not the cholesterol-lowering compound. We simply do not know.

Natural Cholesterol Management Alternatives

The coupling of target levels of plant sterols (2-3g/day) and soluble fiber (10-25g/day) with a calorie-mindful diet replacing saturated and trans fats with monounsaturated fats can achieve results similar to many cholesterol-lowering medications. Niacin and omega-3s from fish oil also can play a role. Check with your health care professional about a complete program. Click Here to Learn More.