1. Red yeast rice (Monascus purpureus) supplements: Case series assessment of spontaneously reported cases to The Netherlands Pharmacovigilance Centre Lareb
- Author
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Sonja van de Koppel, Misha F. Vrolijk, Florence van Hunsel, FSE Campus Venlo, and RS: FSE UCV Adaptive responses in relation to health effect and safety of nutrition
- Subjects
medicine.medical_specialty ,Drug-Related Side Effects and Adverse Reactions ,HEPATOTOXICITY ,DYSLIPIDEMIA ,Short Report ,mechanism ,Age and sex ,030226 pharmacology & pharmacy ,TOXICITY ,Monascus purpureus ,statins ,03 medical and health sciences ,Pharmacovigilance ,0302 clinical medicine ,Short Reports ,Internal medicine ,medicine ,Red yeast rice ,Monacolin K ,Adverse Drug Reaction Reporting Systems ,Humans ,Pharmacology (medical) ,030212 general & internal medicine ,red yeast rice ,Adverse effect ,COENZYME-Q10 ,Netherlands ,Pharmacology ,Biological Products ,biology ,business.industry ,case series ,biology.organism_classification ,medicine.disease ,Monascus ,SIMVASTATIN ,Safety profile ,VARIABILITY ,CITRININ ,SAFETY ,Stoxicity ,business ,Dyslipidemia ,DIETARY-SUPPLEMENTS - Abstract
Serious concerns are expressed on the safe use of red yeast rice (RYR) supplements. The aim of the present study was to analyse cases received by Lareb on RYR-related adverse health events. These cases were analysed for the number of reports, number of adverse drug reactions (ADRs), causality, seriousness of the reaction, latency-period, age and sex of the patients, concomitant medication and type of reporter. A total of 94 individual reports were collected by Lareb, corresponding with 187 ADRs. The analysis showed most reported ADRs were labelled musculoskeletal and connective tissue disorders (n = 64), gastrointestinal disorders (n = 33) and general disorders and administration site conditions (n = 23). The use of RYR supplements should be considered as a significant safety concern. Exposure to monacolin K could lead to serious adverse effects. To fully assess the safety profile of RYR supplements, more research is necessary to compose a complete ADR profile of RYR supplements.
- Published
- 2020