"Red yeast rice" is a red mould grown on rice which 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 nonproprietary 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 cases of muscle damage (myalgia that is often intense);
- 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 - especially those particularly vulnerable due to genetic predispositions, pathologies or ongoing treatments, etc. - to a health risk. 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.
In order to collect as much data as possible to refine its assessment, ANSES submitted a draft opinion for consultation by the various stakeholders (consumer associations, manufacturers, etc.) and the authorities (international agencies, etc.) through 15 December 2013. The information gleaned from this consultation had been integrated in the Agency's final opinion.
Medical supervision, information and status clarification needed
In its assessment, ANSES recommends that consumption of red yeast rice food supplements should include:
- medical supervision, including a liver function test prior to taking these products and the monitoring of statin-related liver and muscle toxicity;
- readily available information on the precautions of 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 medication and foods).
ANSES also considers that the status of these products should be clarified on the EU level and that their marketing networks must be able to ensure 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 recommends thatconsumers:
- seek advice from a doctor before taking food supplements containing red yeast rice;
- avoid red yeast rice food supplements if they belong to the following population groups:
- pregnant and breast-feeding 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;
- heavy consumers of grapefruit (juice or fruit) or alcohol.
- 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 emphasises the following points for healthcare professionals:
- 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.