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redyeast

By April 28, 2025May 3rd, 2025No Comments

 Red yeast rice

SUMMARY: The extract of red yeast rice (RYR) is the most effective cholesterol-lowering nutraceutical on the market. In particular, its effectiveness is directly related to the amount of monacolin K within the extract (up to 10 mg/day). safe and effective. However, red rice is often mislabelled and misused, in which case it is dangerous.  See below DANGER FOR RED YEAST RICE.

Red Yeast Rice for Hypercholesterolemia – The extract of red yeast rice (RYR) is the most effective cholesterol-lowering nutraceutical on the market. In particular, its effectiveness is directly related to the amount of monacolin K within the extract (up to 10 mg/day). Consuming monacolin K on a daily basis reduces low-density lipoprotein (LDL) cholesterol plasma levels between 15% and 25% within 6 to 8 weeks. The monacolin K found in RYR is a safe and effective supplement for managing mild to moderate hypercholesterolemia in people with no additional cardiovascular risk factors.  The most recent, by Gerard et al., included 20 studies with RYR doses varying between 1,200 mg and 4,800 mg/day and containing from 4.8 mg to 24 mg of monacolin K. The meta-analysis demonstrated that RYR reduced LDL-C by an average of 1.02 mmol/L (39.4 mg/dL) after 2 to 24 months of treatment compared to placebo. This effect on LDL lowering was not different from moderate-intensity statins (0.03 mmol/L) such as pravastatin 40 mg and lovastatin 20 mg. Recent concerns have been voiced regarding the safety of RYR after publication of case reports that claimed toxicity.48 However, according to a recent meta-analysis of 53 RCTs with a total of 8,535 patients (4,437 in the RYR treatment arm and 4,303 in the control arm), use of monacolin K is not associated with an increased risk of muscular adverse events (OR 0.94, 95% CI, 0.53–1.65).49 Furthermore, the study demonstrated a reduced risk of nonmuscular adverse events (OR 0.59, 95% CI, 0.50–0.69) and serious adverse events (OR 0.54, 95% CI, 0.46–0.64) compared to the control group.

DANGER FOR RED YEAST RICE.

“A products analysis report from 2010 tested 12 products commercially available in the U.S. and reported that per 600 mg capsule, total monacolins content ranged from 0.31 to 11.15 mg. A 2017 study tested 28 brands of red yeast rice supplements purchased from U.S. retailers, stating “the quantity of monacolin K varied from none to prescription strength.”
     [[RR comment — Somehow I don’t think USP would be impressed with a 30-fold concentration range of the active ingredient.]]
[[Note:  Monacolin K is the same compound as lovastatin.]] “Different strains of Monascus fungus will produce different amounts of monacolins. The ‘Went’ strain of Monascus purpureus (purpureus=dark red in Latin), when properly fermented and processed, will yield a dried red yeast rice powder that is approximately 0.4% monacolins, of which roughly half will be monacolin K (chemically identical to lovastatin).”
     “Many of these avoid FDA regulation by not having any appreciable monacolin content. Their labels and websites say no more than “fermented according to traditional Asian methods” or “similar to that used in culinary applications”. The labeling on these products often says nothing about cholesterol lowering. If products do not contain lovastatin, do not claim to contain lovastatin, and do not make a claim to lower cholesterol, they are not subject to FDA action.”
     [[RR comment:  I’d heard years ago that red rice yeast sold as cholesterol-lowering had to have the lovastatin removed prior to sale. Not sure if that was true or for which country.]]
     Safety:   “The safety of red yeast rice (RYR) products has not been established. Some supplements have been found to contain high levels of citrinin, which can be toxic to the liver, kidneys, and cellular DNA. Commercial products also have highly variable amounts of monacolins and rarely declare this content on the label, making risk assessment difficult. Ingredient suppliers have been suspected of “spiking” red yeast rice preparations with purified lovastatin. One published analysis reported several commercial products as being almost entirely monacolin K—which would occur if the drug lovastatin was illegally added—rather than the expected composition of many monacolin compounds.”
     [[RR comment:  Wiki page on citrinin states, “Citrinin is a mycotoxin which is often found in food. It is a secondary metabolite produced by fungi that contaminates long-stored food and it can cause a variety of toxic effects, including kidney, liver and cell damage. Citrinin is mainly found in stored grains, but sometimes also in fruits and other plant products.”]]
     “In a press release the FDA “…is warning consumers to not buy or eat red yeast rice products… may contain an unauthorized drug that could be harmful to health.” The rationale for “harmful to health” was that consumers might not understand that the dangers of monacolin-containing red yeast rice are the same as those of prescription statin drugs.”
     “There are reports in the literature of muscle myopathy and liver damage resulting from red yeast rice usage. From a review: “The potential safety signals of myopathies and liver injury raise the hypothesis that the safety profile of RYR is similar to that of statins. Continuous monitoring of dietary supplements should be promoted to finally characterize their risk profile, thus supporting regulatory bodies for appropriate actions.” The European Food Safety Authority (EFSA) Panel on Food Additives and Nutrient Sources added to Food concluded that when red yeast rice preparations contained monacolins, the Panel was unable to identify an intake that it could consider as safe.”
     Bottom line, Roc, red rice yeast can be dangerous. The dangers can arise from A) people thinking that it’s safe and has no side effects, B) people consuming one of the RRY products that is high in lovastatin, while also taking a doctor-prescribed lovastatin pills, and C) people being screwed out of their money by RRY products that contain zero lovastatin, and D) buying herbs that are illegally spiked by prescription drugs.
   That last one reminds me of herbal supplements that were marketed as “calming.” Yes, they worked, but it was because they contained a sleeping pill drug. Ditto for an herbal supplement that was marketed as “male enhancement.” It contained sildenafil, a.k.a. the ingredient in Viagra.
Herbal supplements, in general, are risky, and I think you are NOT doing justice to your readers by your stating a blanket “they’re safe.”
     There are so many exceptions and complexities such as drug-drug interactions.