High cholesterol and hepatic steatosis, can I take monacolin K supplements?

Dear Doctor, I have been taking Armolipid plus for some time to control my cholesterol which is high(above 200). Now I have read that monakolin k can lead to liver problems. I have hepatic steatosis probably caused by high cholesterol levels, can I take monakolin K supplements without problems or do I need to change supplements and if so which one do you recommend? Thank you.

Dear Julius, 

The Armolipid plus product you mentioned is a dietary supplement from a different manufacturer than ours, so we cannot give specifics about it. With respect to the question about the intake of monacolin K ( one of the substances obtained as a result of the fermentation of common cooking rice by a fungus, Monascus purpureus) , which for years has been used in nutraceutical food supplements as a valuable support for those who could not keep their cholesterol under control but did not need or want to take statins, we inform you that today it can no longer be used as it was in the past: the European Food Safety Authority (EFSA) has in fact decided that the dosages allowed in supplements were too high for a substance that behaves in all respects like a drug.

With the publication in the Official Journal of the European Union on June 2, 2022 of Commission Regulation (EU) 2022/860, monacolin K was added to the list of substances whose use is permitted only under specific conditions. Under the new provisions, all supplements that provide 3 or more mg of total monacolin K monacolines per day are prohibited, and the claim of cholesterol-lowering benefits can no longer be used. 

Warnings related to the presence of fermented red rice are as follows: This product should not be consumed by pregnant or lactating women, children under the age of 18, and adults over the age of 70. Consult a physician about consuming this product if health problems occur. The product should not be consumed if you are taking cholesterol-lowering medications. 

It should not be consumed if you already consume other products containing fermented red rice. It is recommended not to consume 3 or more mg per day of monacolins from fermented red rice. There is no evidence to our knowledge of contraindications of monacolin k with your hepatic steatosis problem. Among our products, we can recommend Cardiol Forte. 

Cardiol Forte contains: omega-3 from fish oil useful in reducing triglycerides, fermented red rice extract, extract from artichoke leaves (the biophenols contained have cholagogic, choleretic and hepatoprotective activities, and the flavonoids present inhibit cholesterol biosynthesis and protect LDL from oxidative damage), polyphenols from olive tree whose activities in protecting LDL cholesterol from oxidation have been demonstrated by numerous studies, and coenzyme Q10.

As a reminder that dietary supplements should not be understood as substitutes for a varied and balanced diet and healthy lifestyle, we generally recommend that you consult your treating physician who is aware of the medications you are taking, possible interactions with the ingredients of the dietary supplements you habitually consume or would like to add to your diet, and is aware of your clinical course. 

Best regards Silvia Lisciani Ph.D. Nutritionist biologist