Red yeast rice-based food supplements

Red yeast rice is a red mould that is grown on rice. It is used in many food supplements claiming to maintain a normal level of cholesterol.

Consumers use these food supplements with or without medical advice in addition to, as a replacement for, or as an alternative to cholesterol-lowering treatments. Red yeast rice in fact contains several compounds known as monacolins at levels which may vary greatly from one product to another.

One of these substances, monacolin K, has the pharmacological characteristics of statins, meaning that it has the ability to inhibit an enzyme (HMG-CoA reductase) involved in the cholesterol synthesis pathway. Monacolin K is therefore marketed as a drug under the international non-proprietary name “lovastatin” in the United States, Canada, Germany, Austria, Spain, Portugal and Greece, but not in France.

Adverse effects reported to ANSES

Since the creation of its nutrivigilance system, ANSES has received 25 well-documented reports of adverse effects potentially associated with the consumption of food supplements containing red yeast rice.

The 12 cases in which causality was “very likely” or “likely” include:

• a majority of muscle damage cases (often intense myalgia);
• three cases of liver damage, both independent of and associated with muscle damage.

The nutrivigilance cases reported in France or in other countries sharing information on the subject are very similar to the clinical cases for lovastatin that are well-documented in the scientific literature.
The assessment therefore concludes that, under current conditions the use of red yeast rice-based food supplements containing monacolins can expose consumers to a health risk – especially those particularly susceptible due to genetic predispositions, pathologies, ongoing treatments, etc. This health risk may be higher if their consumption is not paired with medical advice and supervision, including liver function tests and warnings on precautions for use and the potential adverse effects to watch for.

Medical supervision, information and status clarification needed

It is therefore recommended that consumption of food supplements containing red yeast rice should include:

• medical supervision, including a liver function test prior to taking the product and the monitoring of statin-related liver and muscle toxicity;
• readily available information on the precautions for use and contra-indications of statins with regard to groups at risk (in particular pregnant women and individuals with impaired hepatic function) and risk situations (possible interactions with medications or foods).

ANSES also considers that the status of these products should be clarified on the EU level and that their marketing networks must be capable of ensuring compliance with these recommendations.

ANSES emphasises the fact that high blood cholesterol is not a disease but rather a factor which increases the risk of cardiovascular disease, and that prevention must first and foremost be based on a healthy non-sedentary lifestyle including a varied diet and regular exercise.

ANSES recommendations

Pregnant or breastfeeding women, children and adolescents, people over the age of 70, people with predisposing conditions (such as kidney failure, muscle disease, untreated hypothyroidism or progressive liver disease), as well as people who consume large amounts of grapefruit (juice or fruit) and heavy alcohol drinkers should avoid taking red yeast rice supplements.

ANSES recommends that consumers:

• seek advice from a doctor before taking food supplements containing red yeast rice;
• avoid taking red yeast rice food supplements if they are taking statin-based cholesterol-lowering medication or if they were forced to stop taking such medication due to an adverse reaction ("statin-intolerant" patients), unless a doctor has given specific medical advice to the contrary.

ANSES also wishes to remind healthcare professionals that:

• food supplements containing red yeast rice cannot be used as an alternative to cholesterol-lowering medication;
• individuals taking medication which could interfere with the metabolism of lipids or statins should not take food supplements containing red yeast rice;
• any adverse effects occurring after taking food supplements containing red yeast rice must be reported to the Agency.