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Review
. 2024 Feb 2;16(3):444.
doi: 10.3390/nu16030444.

The Impact of Red Yeast Rice Extract Use on the Occurrence of Muscle Symptoms and Liver Dysfunction: An Update from the Adverse Event Reporting Systems and Available Meta-Analyses

Giuseppe Danilo Norata  1   2 , Maciej Banach  3
Affiliations
Review

The Impact of Red Yeast Rice Extract Use on the Occurrence of Muscle Symptoms and Liver Dysfunction: An Update from the Adverse Event Reporting Systems and Available Meta-Analyses

Giuseppe Danilo Norata et al. Nutrients. .

Abstract

Red yeast rice (RYR) has a cholesterol-lowering effect due to the presence of bioactive components (monacolins, mainly monacolin K) that act by inhibiting the activity of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase. The European Food Safety Authority (EFSA) assessed the use of RYR and, while pointing out several uncertainties regarding the available data, raised a warning related to the safety of RYR when used as a food supplement at a dose of monacolin as low as 3 mg/day. In their decision in June 2023, EFSA approved the use of monacolins from RYR at doses less than 3 mg/day. We therefore decided to interrogate the different adverse event reporting systems (FAERS and CAERS) and analyse the characteristics of the cases reported to be associated with RYR supplements, and we reviewed the most recent meta-analyses with a focus on the occurrence of muscle symptoms and liver dysfunction. In terms of all musculoskeletal disorders from September 2013 (when the first case related to RYR consumption was recorded) to 30 September 2023, 363,879 cases were reported in the FAERS, with the number of cases related to RYR consumption being very small and accounting for 0.008% of cases. In the same time frame, 27,032 cases of hepatobiliary disorders were reported, and the cases attributable to RYR ingestion accounted for 0.01% of all cases. A low rate of muscle symptoms and liver dysfunction attributed to RYR ingestion was also observed in the CAERS database, where only 34 cases of adverse muscle events and 10 cases of adverse liver events reported RYR as the suspect product, while 19 cases of both muscle events and 10 cases of adverse liver events reported it as a concomitant product. This profile mirrors that of meta-analyses of randomised clinical trials of RYR, in which RYR use was not associated with either liver dysfunction or muscular adverse symptoms.

Keywords: LDL-C; lipid lowering; liver adverse events; monacolin K; muscle adverse events; red yeast rice.

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Conflict of interest statement

G.D.N. reports Grants from Amgen, Novartis, Pfizer; consultant to MSD, Amarin, and Viatris; M.B.: speaker’s bureau: Amgen, Daichii Sankyo, Kogen, KRKA, Pfizer, Polpharma, Mylan/Viatris, Novartis, Novo-Nordisk, Sanofi-Aventis, Teva, Zentiva; consultant to Adamed, Amgen, Daichii Sankyo, Esperion, NewAmsterdam, Novartis, Novo-Nordisk, Sanofi-Aventis; Grants from Amgen, Daichii Sankyo, Mylan/Viatris, and Sanofi; CMO at Nomi Biotech Corporation and Dairy Biotechnologies.

Figures

Figure 1
Figure 1
Muscular and hepatic adverse events from the FAERS database. The number of muscular or hepatic adverse events in people taking red yeast rice was retrieved from the FDA Adverse Event Reporting System (FAERS) database and analysed by gender (a) and age (b).
Figure 2
Figure 2
Muscular and hepatic adverse events from the CAERS database. The number of muscular or hepatic adverse events in people taking red yeast rice was retrieved from the CFSAN Adverse Event Reporting System (CAERS) database and analysed by suspect product (a), gender (b), and age (c).
See this image and copyright information in PMC

References

    1. Cicero A.F.G., Fogacci F., Zambon A. Red Yeast Rice for Hypercholesterolemia: JACC Focus Seminar. J. Am. Coll. Cardiol. 2021;77:620–628. doi: 10.1016/j.jacc.2020.11.056. - DOI - PubMed
    1. Buzzelli L., Segreti A., Di Gioia D., Lemme E., Squeo M.R., Nenna A., Di Gioia G. Alternative lipid lowering strategies: State-of-the-art review of red yeast rice. Fitoterapia. 2024;172:105719. doi: 10.1016/j.fitote.2023.105719. - DOI - PubMed
    1. Chen G., Chen W., Xu J., Ma G., Hu X., Chen G. The current trend and challenges of developing red yeast rice-based food supplements for hypercholesterolemia. J. Future Foods. 2023;3:312–329. doi: 10.1016/j.jfutfo.2023.03.003. - DOI
    1. Rahmani P., Melekoglu E., Tavakoli S., Malekpour Alamdari N., Rohani P., Sohouli M.H. Impact of red yeast rice supplementation on lipid profile: A systematic review and meta-analysis of randomized-controlled trials. Expert Rev. Clin. Pharmacol. 2023;16:73–81. doi: 10.1080/17512433.2023.2138342. - DOI - PubMed
    1. FDA Warns Consumers to Avoid Red Yeast Rice Products Promoted on Internet as Treatments for High Cholesterol. [(accessed on 3 November 2023)]; Available online: https://www.in.gov/health/food-protection/recalls-and-advisories/2007-ad...