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.