Red Yeast Rice  

• Red Yeast Rice (RYR) is a widely available dietary supplement used by millions of patients as an alternative therapy for high cholesterol. Even many physicians use RYR as an acceptable alternative in patients intolerant of other lipid-lowering medications without realizing its potential dangers and toxicity from high doses of hidden statins.^{1, 2}

• Chinese RYR has been used as a food colorant and medicine in China for centuries and is increasingly popular cholesterol lowering agent. It is a dietary supplement containing monacolins, unsaturated fatty acids, and phytosterols capable of lowering LDL (low-density lipoprotein cholesterol). It contains 14 active compounds called monacolins that inhibit cholesterol synthesis by the liver, similar to that by statins.³

• Different commercial preparations of RYR have widely different concentrations of monacolins, the bioactive ingredient that lowers LDL-C. Monacolin levels are not standardized among marketed products and are generally not published on labels. Monacolin K was initially isolated by Endo from aspergillus species in 1979 and later purified and marketed as lovastatin by Merck.

• There are at least 31 proprietary red yeast preparations. Because of limited oversight by the government, and variable quality control by the manufacturers, the monacolin content of different RYR products may differ dramatically from bottle to bottle.³ This is because the law allows each manufacturer to set its own standards regarding the ingredient composition.

• A scientific evaluation of 12 commercial RYR formulations labeled as “600 mg/capsule” of active product showed a 36-fold variation in total monacolins and 100-fold variation in monacolin K (lovastatin 0.1 to 10.0 mg) per capsule.

• Cholestin is a popular brand and 2.4 g/d can lower LDL-C by 40% compared to 25% for lovastatin 40 mg/d. In 1998 FDA ruled that cholestin is not a dietary supplement but an unapproved drug. Long-term safety of this and other RYR has not been ascertained yet.

• Red yeast rice should never be taken with other statins because of greatly increased toxicity.

• One–third of the tested formulations of RYR contained elevated levels of citrinin, a mycotoxin that is nephrotoxic (kidney damaging) in animals.

• Even when used alone, red yeast rice should be taken under the supervision of a physician with appropriate monitoring since, myopathy, rhabdomyolysis and hepatotoxicity have been reported.^4-6

• Now that the price of generic statins such as lovastatin, pravastatin, and simvastatin has come down to $4/month, the cost of RYR is five times higher than statins and there is no justification for its use.

• The currently available Chinese RYR preparations costs $20–30/mo, whereas the cost of cholesterol-lowering medications in the past was ten times higher ($120–300/mo), making RYR an attractive alternative for financial reasons.

• Although RYR can lower LDL-C, lack of standardization and 100-fold variation in the content of the active ingredient, makes it a dangerous supplement to lower cholesterol or prevent cardiovascular disease (CVD).

Sources

1. Halbert SC, French B, Gordon RY, et al. Tolerability of red yeast rice (2,400 mg twice daily) versus pravastatin (20 mg twice daily) in patients with previous statin intolerance. Am J Cardiol. Jan 15 2010;105(2):198-204.

2. Venero CV, Venero JV, Wortham DC, Thompson PD. Lipid-lowering efficacy of red yeast rice in a population intolerant to statins. Am J Cardiol. Mar 1 2010;105(5):664-666.

3. Gordon RY, Cooperman T, Obermeyer W, Becker DJ. Marked variability of monacolin levels in commercial red yeast rice products: buyer beware! Arch Intern Med. Oct 25 2010;170(19):1722-1727.

4. Mueller PS. Symptomatic myopathy due to red yeast rice. Ann Intern Med. Sep 19 2006;145(6):474-475.

5. Prasad GV, Wong T, Meliton G, Bhaloo S. Rhabdomyolysis due to red yeast rice (Monascus purpureus) in a renal transplant recipient. Transplantation. Oct 27 2002;74(8):1200-1201.

6. Roselle H, Ekatan A, Tzeng J, Sapienza M, Kocher J. Symptomatic hepatitis associated with the use of herbal red yeast rice. Ann Intern Med. Oct 7 2008;149(7):516-517.