Red yeast rice (Monascus purpureus) supplements: Case series assessment of spontaneously reported cases to The Netherlands Pharmacovigilance Centre Lareb

Misha F. Vrolijk*, Sonja van de Koppel, Florence van Hunsel

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

5 Citations (Web of Science)

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.

Original languageEnglish
Pages (from-to)2146-2151
Number of pages6
JournalBritish Journal of Clinical Pharmacology
Volume87
Issue number4
Early online date18 Nov 2020
DOIs
Publication statusPublished - Apr 2021

Keywords

  • case series
  • mechanism
  • Monascus purpureus
  • red yeast rice
  • statins
  • Stoxicity
  • DIETARY-SUPPLEMENTS
  • CITRININ
  • COENZYME-Q10
  • STATINS
  • SAFETY
  • HEPATOTOXICITY
  • DYSLIPIDEMIA
  • VARIABILITY
  • SIMVASTATIN
  • TOXICITY

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