“The new Regulation of the European Commission on monacolin protects patients who use the supplement based on fermented red rice, useful for cholesterol control. The EU has in fact established that from next 22 June the sale of products containing single portions for daily use with an amount equal to or greater than 3 mg of monacolin from fermented red rice will be prohibited throughout the European territory, which can be purchased as well as in pharmacies. even at the supermarket, without medical supervision. “This was underlined by Alberto Corsini, full professor at the Department of Pharmacological and Biomolecular Sciences of the University of Milan, commenting to the Adnrkonos Salute on the decision of the European Commission which thus adopted Regulation no. 2022/860 published in the Official Journal of the EU last June 2. The Regulation amends Annex III of Regulation (EC) No. 1925/2006 of the European Parliament and of the Council as regards fermented red rice monacolines.
From the EU “a right decision – underlines Corsini – since thetaking monacolin with a dosage equal to or greater than 3 mg, has been shown, can cause adverse events including muscle aches, cramps, myositis, mild liver toxicity, gastrointestinal and skin reactions. Finally, cases of rhabdomyolysis, although they are rare events (the frequency is one case in 300 thousand patients treated with monacolin), are however typical of those who take drugs such as statins. These adverse events related to the use of monacolin present in fermented red rice as early as 2018 had been reported by various phytosurveillance sites in France, Belgium, Germany, Italy, the USA and the WHO“.
“A monacolin dosage of 10 mg – explains the pharmacologist – it is a very important and effective dosage because contributes to lower cholesterol levels by up to 25%. But it is a dosage that is also present in the pharmaceutical forms of lovastatin. We know that monacolin K is chemically identical to lovastatin, which is a therapeutically used statin for cholesterol. For which there has always been this overlap between a dosage for clinical and therapeutic use with a dosage for health use. This thing had to be clarified, at least redefined. And the new EU Regulation goes in this direction “.
The new document “highlights not to give this supplement to patients under 18 or over 70, due to the lack of data on safety and efficacy – continues Corsini – Obviously remember that monacolin is not indicated in pregnancy, and especially recommends that you be careful with those patients who already use cholesterol control drugs. Recommendations and clarifications are right for the protection of the patient. Even because, while drugs such as statin are prescribed by the doctor, fermented red rice can be purchased at the supermarket without any control – reiterates the pharmacologist – For this reason, a few years ago a document was drawn up coordinated by Professor Andrea Poli, president of Nutrition Foundation Italy, to which numerous scientific societies had adhered in which the importance of the intentional citizen was highlighted to use the monacolin-based supplement, talk to your doctor first. ”
Hypercholesterolemia in Italy affects 10 million people. “Of these, about 4 million have mild cholesterol problems. They do not have to do statin-based treatments – specifies the expert – but, in addition to following a correct lifestyle, they could potentially use red rice supplements. fermented or with other natural active ingredients already on the market, able to reduce cholesterol. They are patients with a very low risk, for this reason they are not forced to undergo a treatment with statins, but in any case they need to reduce cholesterol levels . Therefore the population that can take advantage of these supplements is very large. Hence the importance of having a document that regulates a situation that has been left unchecked for too long, without a health filter. Patients can finally rest assured and start treatment with supplements to keep cholesterol down, a treatment that we remember is for life “.
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