Red yeast rice component resembles lovastatin and may yield similar adverse events
Adverse reactions to dietary supplements containing red yeast rice: assessment of cases from the Italian surveillance systemLiterature - Mazzanti G, Moro PA, Raschi E et al., - British Journal of Clinical Pharmacology. First published: 19 January 2017. DOI: 10.1111/bcp.13171
- Of 1261 reports in the analysed period, 52 (4.1%) concerned 55 suspected ARs to dietary supplements containing RYR, in 37 women and 14 men, between the ages of 35 and 85. The most commonly used products were Armolipid plus (55%), and Colestat (10%), which both contain other components besides RYR.
- Use of RYR preparations was for hypercholesterolaemia in all cases. Total daily dose of monacolin K was 3 mg in all but four reports.
- 14 cases (27%) experienced a serious reaction, 13 of which that required hospitalisation (serious hepatic reactions in 6 out of 10 cases).
- 20 reactions (36%) concerned ‘musculoskeletal and connective tissue disorders’, according to the MEdDRA terminology, followed by 12 ‘gastrointestinal disorders’ (22%), 10 ‘hepatobiliary disorders’(18%), and 9 ‘skin and subcutaneous tissue disorders’(16%).
- Causality assessment yielded one ‘certain’, 31 probable reactions (56%), 18 possible (34%), 3 unlikely and 2 unassessable reactions.
- In the WHO-Vigibase, of 75 reports on dietary supplements with RYR as active substance, 22 reported myalgia, 7 reported muscle spasm, 7 chest pain, and 7 drug interactions, and rhabdomyolysis and pain in extremity and dizziness were each reported in 5 persons.
Reported cases are described in detail in the article
These observations raise the hypothesis that the safety profile of RYR is similar to synthetic statins, as myopathies, cutaneous reactions, gastrointestinal and liver reactions emerged as potential safety signals. Clinicians should be aware of the fact that monacolin K contained in RYR is identical to lovastatin. Therefore, early monitoring of liver function and signs of muscle injury should be considered, and self-medication with RYR should be discouraged, especially in those who previously experienced adverse reactions to statins.