How Does The Us Food And Drug Administration Regulate Red Yeast Rice Products
According to the FDA, red yeast rice products that have enhanced or added lovastatinâwhich is structurally identical to monacolin Kâcannot be marketed as a dietary supplement in the United States. This regulation is based on the FDAâs approval of lovastatin as a new drug before it was ever marketed as a food or dietary supplement.
On several occasions, the FDA sent warning letters to companies selling red yeast rice products that had enhanced or added lovastatin, telling the companies to correct their violations.
Red Yeast Rice For Hyperlipidemia: A Meta
- 1Department of Traditional Chinese Medicine, Punan Hospital, Shanghai, China
- 2Department of Traditional Chinese Medicine, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China
- 3Department of Encephalopathy, Guangyuan Hospital of Traditional Chinese Medicine, Guangyuan, China
- 4Shanghai Skin Disease Hospital, School of Medicine, Tongji University, Shanghai, China
Background: RYR is a commonly used lipid-lowering dietary supplements in Asian and European countries, showing considerable benefits and low toxicity. This quantitative study aims to present high-quality evidence regarding the efficacy and safety of RYR in treating hyperlipidemia, in order to promote its clinical application.
Methods: PubMed, embase, and Cochrane Central Register of Controlled Trials databases were systematically searched, and high-quality randomized controlled trials comparing RYR with non-RYR interventions were included. RevMan5.3 software was used to conduct the meta-analysis.
RYR at 2004800 mg daily appears to be a safe and effective treatment for hyperlipidemia, effectively regulating blood lipid levels with an exceptional impact on TG. Looking forward, high-quality clinical trials with longer observation periods are required to evaluate the efficacy and safety of RYR as a long-term medication.
Systematic Review Registration: , identifier .
Inclusion And Exclusion Criteria
The inclusion criteria were as follows: 1) participants: patients diagnosed with hyperlipidemia 2) intervention: red yeast rice alone or combined therapies 3) comparison: conventional or placebo therapies 4) outcomes: low-density lipoprotein cholesterol, total cholesterol, triglyceride, high density lipoprotein cholesterol, apolipoprotein A-I, apolipoprotein B, adverse events, and 5) study design: randomized controlled trials. Studies were excluded if they met the following exclusion criteria: 1) participants with comorbidities 2) different drug forms used in the experimental and control group 3) co-interventions that used lipid-lowering drugs other than RYR, and 4) not high-quality RCTs with a Jadad score 4 in efficacy and safety analysis, so that the efficacy and safety of RYR could not be judged.
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Alternatives To Red Yeast Rice For Reducing Cholesterol
There are safe, natural, and enjoyable ways to keep your blood cholesterol balanced. You dont need to take a risky supplement with an ingredient list thats hiding something.
Other ways to reduce cholesterol include:
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Staying physically active. The American Heart Association recommend getting 150 minutes of moderate-to-vigorous-intensity exercise every week. Thats just a target you can work up to it slowly, finding ways to be active that are comfortable and sustainable within your lifestyle.
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Avoiding smoking, or quitting if you already do. Smoking increases levels of bad cholesterol in the blood. However, quitting smoking increases levels of good cholesterol and reduces bad cholesterol.
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Maintaining a moderate body weight. If your body mass index is 25 or over, losing 510% of your body weight could significantly affect your cholesterol levels. Work with a healthcare professional to identify your moderate weight range.
One of the most powerful tools for controlling blood fats is a diet that your body responds to in a healthy way.
The ZOE at-home test can identify how your blood fats respond to different foods. Using that information, we recommend a diet thats right for your body. We also measure your blood sugar response and check the health of your gut microbiome.
How Do Plant Stanols Help Lower Cholesterol Levels
When we digest food, the gallbladder releases bile into the intestines. The bile contains cholesterol and other compounds that help us digest and absorb lipid nutrients in the food we eat. The bile and cholesterol are reabsorbed in the lower parts of the intestines. Plant stanols keep the intestines from absorbing the cholesterol, and the cholesterol leaves the body through the stool.
Plant stanols work best when they are combined with a diet low in saturated fat and cholesterol. Even patients who eat a 100% plant-based diet with very limited amounts of cholesterol can lower LDL cholesterol levels by taking these supplements.
Plant stanols are most effective when they are taken with food. It is recommended to take them 3 times a day with meals.
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What Should I Tell My Care Team Before I Take This Medication
They need to know if you have any of these conditions:
- Frequently drink alcohol
- Muscle aches or weakness
- Other medical condition
- An unusual or allergic reaction to red yeast rice, went yeast, lovastatin, other ‘statin’ medications, other supplements, foods, dyes, or preservatives
- Pregnant or trying to get pregnant
Risks Of Red Yeast Rice Extract
Because red yeast rice extract contains lovastatin, it can cause the same side effects as chemically created statins. These side effects include higher than normal liver function test results and muscle weakness . Because the extract contains less lovastatin than prescription statins do, side effects are less common with the extract.
Red yeast rice extracts are not monitored by the FDA. The lack of FDA regulation means the product could contain ingredients besides the extract that could cause side effects or safety issues. In the past, some manufacturers of red yeast rice extract added chemically created lovastatin to boost the power to reduce LDL cholesterol levels. The FDA made the companies stop this practice, as the altered product was no longer completely natural. Also, different brands of the product may work better than others and there can even be differences among batches from the same manufacturer. A higher cost does not guarantee a better product.
It is important to talk to your doctor before taking red yeast rice extract or any other medication or supplement and to have regular follow-up visits with your doctor. It is not recommended to take red yeast rice extract and prescription statins together.
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Solgar Red Yeast Rice
Solgar doesnt get very fancy with their supplements, but with a red yeast rice product, thats precisely what you are looking for.
Its tested and certified free of the kidney toxin citrinin, and while there are a few extra binders and fillers, the real priority with a supplement like this is purity, not minimalist supplement design. Its a very solid choice for a no-nonsense red yeast rice supplement.
The Fda Creates Confusion And Controversy
You would think that with such compelling research behind it, the Food and Drug Administration would be thrilled to see a natural product being sold in health food stores and pharmacies that could actually live up to the advertising. Whats more, the manufacturer went to great lengths to standardize and sterilize the ingredients in Cholestin.
Would it come as a surprise to learn that on May 20, 1998, the FDA ruled that Cholestin was not a dietary supplement but rather an unapproved drug? That meant that the agency wanted to ban this formulation of red yeast rice:
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Why Take Red Yeast Rice
Red yeast rice has been used in traditional Chinese medicine for centuries to improve digestion and circulation. The most beneficial effect is its potential to lower cholesterol. Many people opt for supplements as opposed to statins because of the potential side effects. Research links statins with possible side effects like liver damage, kidney damage, memory loss and skeletal muscle damage. It also has the potential to control weight gain and possibly prevent obesity. Studies also show that it may have anticancer properties and may help reduce inflammation that leads to serious health conditions.
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What Should I Watch For While Using This Medication
Visit your doctor or health care professional for regular check-ups. You may need regular tests to make sure your liver is working properly.
Tell you doctor or health care professional right away if you get any unexplained muscle pain, tenderness, or weakness, especially if you also have a fever and tiredness.
Some drugs may increase the risk of side effects from this supplement. If you are given certain antibiotics or antifungals, you should stop taking this supplement during those treatments. Check with your doctor or pharmacist for advice.
If you are scheduled for any medical or dental procedure, tell your healthcare provider that you are taking this supplement. You may need to stop taking this supplement before the procedure.
Do not use this drug if you are pregnant or breast-feeding. Serious side effects to an unborn child or to an infant are possible. Talk to your doctor or pharmacist for more information.
Herbal or dietary supplements are not regulated like medicines. Rigid quality control standards are not required for dietary supplements. The purity and strength of these products can vary. The safety and effect of this dietary supplement for a certain disease or illness is not well known. This product is not intended to diagnose, treat, cure or prevent any disease.
The Food and Drug Administration suggests the following to help consumers protect themselves:
Always read product labels and follow directions.
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Red Yeast Rice Side Effects
The risks above are serious enough, but did you know that lovastatin just like regular statins can have serious side effects?
One of the main effects that these statins have is causing muscle weakness. The statins can cause a very serious muscle condition rhabdomyolysis, and this can lead to the breaking down of your muscles, and possibly even to kidney failure. There are a number of muscle related problems that can be caused by taking statins, but these problems may not show up for as long as 4 years after the statins are used for therapy for the first time.
In addition, the statins and lovastatin can actually interact negatively with a number of other drugs, such as those used to treat infections, antibiotics, antidepressants, and other medications that work to lower cholesterol. If you are taking these medications, it is important to check with your doctor before taking any red yeast rice that contains lovastatin.
If You Are Considering Red Yeast Rice
- Do not use red yeast rice to replace conventional care or to postpone seeing your health care provider about a health problem.
- Do not use red yeast rice dietary supplements if you are pregnant, trying to become pregnant, or nursing a child. If you are considering giving a child a red yeast rice dietary supplement, it is especially important to consult the childââ¬â¢s health care provider.
- Do not take red yeast rice in addition to prescription statin drugs.
- Many websites, including sales sites, have information about red yeast rice. Be cautious when you evaluate information from the web not all of it is trustworthy. For more information, see the NCCIH fact sheet Finding and Evaluating Online Resources.
- Federal regulations for dietary supplements are very different fromââ¬âand less strict thanââ¬âthose for drugs. For more information about dietary supplements, see NCCIHââ¬â¢s fact sheet Using Dietary Supplements Wisely.
- Tell all your health care providers about any complementary health approaches you use. Give them a full picture of what you do to manage your health. This will help ensure coordinated and safe care.
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Searching For Alternatives To Statins:
Other readers have found red yeast rice helpful.
On the other hand, they worry about potential side effects.
Q. I am a 73-year-old woman with a long history of high cholesterol. I have had a severe reaction to all statin drugs and cant tolerate any of them.
My total cholesterol was almost 300. After taking red yeast rice twice a day along with Welchol for less than a year, my total cholesterol has come down to 184. My triglycerides are now 300, my HDL 44 and my LDL 80.
So far this has been the only thing that has worked. Even eating a healthy diet did not work. My question is: will I have side effects if I take red yeast rice long term?
A. Red yeast rice is an ancient Chinese food that was also used traditionally as a medicine. It contains compounds called monacolins. These are related to statin medications.
Many people appear to tolerate red yeast rice better than statins. That may be because the dose is generally lower.
What To Know About Red Yeast Rice And Its Health Effects
- medicalnewstoday.com
- Summary: · The review suggests that consuming 310 milligrams of monacolin K daily may have low associated risks. Additionally, it indicates that red
- Matching search results: Stanley Hazen, MD, PhD, Section Head of Preventive Cardiology & Rehabilitation at Cleveland Clinic, says, To my knowledge, this trial is the only one of its kind monitoring hard outcomes like heart attack, stroke and death risk in a randomized
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Efficacy Of Red Yeast Rice
Several meta-analyses of randomized controlled clinical trials have verified the lipid-lowering effects of RYR. 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 after 2 to 24 months of treatment compared to placebo. This effect on LDL lowering was not different from moderate-intensity statins such as pravastatin 40 mg and lovastatin 20 mg. The authors also found a small increase in HDL-C and a decrease in triglycerides of 0.26 mmol/L compared to placebo.14
Red yeast rice has also been shown to improve endothelial function in humans. In a clinical trial by Zhao and colleagues, 50 patients with CHD were randomized to 1,200 mg/day of RYR or placebo for 6 weeks and were monitored for lipid levels, high sensitivity C-reactive protein , and flow-mediated dilation after consuming high-fat meals . At 6 weeks follow-up, those receiving RYR showed reductions in hsCRP and in the total area under the TG curve as well as improved post- and pre-prandial FMD , whereas the placebo group showed no significant changes in serum lipids and FMD.15 However, significant improvements in endothelial reactivity and arterial stiffness have been documented by adding 30 mg coenzyme Q10 or a mix of other antioxidants such as 100 mg green tea dry extract, 20 mg CoQ10, and 20 mg resveratrol to RYR extract.16,17
What Other Drugs Interact With Red Yeast Rice
If your doctor has directed you to use this medication for your condition, your doctor or pharmacist may already be aware of any possible drug interactions or side effects and may be monitoring you for them. Do not start, stop, or change the dosage of this medicine or any medicine before getting further information from your doctor, healthcare provider or pharmacist first.
- Severe interactions of red_yeast_rice include:
Red Yeast Rice has no known mild interactions with other drugs.
This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.
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Possible Side Effects Of Red Yeast Rice Supplements
Taking red yeast rice supplements can cause the same side effects as statins.
In one case, doctors admitted an otherwise healthy, active 64-year-old woman to the hospital after she took a 1.2-gram red yeast supplement for 6 weeks. The supplement led to liver poisoning.
The woman recovered following steroid treatment, but this is not the only recorded hospital admission linking red yeast rice supplements and liver poisoning.
Large doses of monacolin K also increase the risk of rhabdomyolysis a condition where your muscles break down. Compounds from the damaged muscles then enter the bloodstream, where they can damage your kidneys.
Potential Role Of Nutraceuticals In The Management Of Hypercholesterolemia
Hypercholesterolemia is a highly prevalent, well-known dose- and time-dependent cardiovascular disease risk factor: the risk is inversely related to the low-density lipoprotein cholesterol plasma level and directly associated to the time the subject is exposed to elevated LDL-C . Considering the very high prevalence of subjects with suboptimal LDL-C level in the general population , and the relatively small impact of lifestyle improvement on LDL-C levels , great attention has been recently given to single dietary components or natural compounds able to further improve lipid pattern in the context of correct dietary and physical activity habits . Very strict diet and aggressive lifestyle changes have been associated with an LDL-C reduction up to 20% , but medium- to long-term adherence to such intensive lifestyle modification is generally poor, particularly in the primary prevention setting and challenging to implement in the medium to long term in our daily clinical practice .
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What Are Risks Of Red Yeast Rice Use
Red yeast rice is often marketed as a natural supplement however, its use can carry risks:
- May cause muscle, liver, and kidney problems similar to those caused by statins
- Should not be used by people who have liver or kidney disease