Postmarketing nutrivigilance safety profile: a line of dietary food supplements containing red yeast rice for dyslipidemia

Banach, Maciej, Katsiki, Niki, Latkovskis, Gustavs, Rizzo, Manfredi, Pella, Daniel, Penson, Peter E ORCID: 0000-0001-6763-1489, Reiner, Zeljko and Cicero, Arrigo FG (2021) Postmarketing nutrivigilance safety profile: a line of dietary food supplements containing red yeast rice for dyslipidemia. ARCHIVES OF MEDICAL SCIENCE, 17 (4). pp. 856-863.

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Official URL: http://dx.doi.org/10.5114/aoms/133716

Abstract

<h4>Introduction</h4>In the absence of a European standardized postmarketing food supplement surveillance system (nutrivigilance), some member states and companies have developed their own approaches to monitoring potential adverse reactions to secure a high level of product safety. This paper describes the use of a nutrivigilance system in monitoring the incidence of spontaneously reported suspected adverse reactions associated with food supplements containing red yeast rice (RYR).<h4>Material and methods</h4>We report the data from a widely used product marketed under the trademark Armolipid/Armolipid Plus. Postmarketing information was collected in a voluntary nutrivigilance system established by the manufacturing company (Meda Pharma SpA, a Viatris Company, Monza, Italy). From 1<sup>st</sup> October 2004 to 31<sup>st</sup> December 2019, this system captured cases of suspected adverse reactions spontaneously reported by consumers, healthcare professionals, health authorities, regardless of causality.<h4>Results</h4>The total number of case reports received mentioning the RYR food supplement product line was 542, in which 855 adverse events (AEs) were reported. The total reporting rate of AEs was estimated to be 0.037% of 2,287,449 exposed consumers. Of the 542 cases, 21 (0.0009% of exposed consumers) included suspected serious adverse events (SAEs). After careful investigation, 6 cases (0.0003% of consumers exposed) and 6 AEs were assessed by the manufacturer as serious and potentially related to exposure to the above-mentioned RYR-based nutraceutical.<h4>Conclusions</h4>This nutrivigilance-derived data analysis clearly demonstrates a low prevalence of suspected adverse events associated with the red yeast rice product line. Consumer safety of food supplements could be generally improved by raising awareness of the importance of following the indications and warnings detailed in a food supplement's labeling.

Item Type:	Article
Uncontrolled Keywords:	adverse event, dyslipidaemia, nutrivigilance, red yeast rice, supplement
Divisions:	Faculty of Health and Life Sciences Faculty of Health and Life Sciences > Institute of Life Courses and Medical Sciences
Depositing User:	Symplectic Admin
Date Deposited:	30 Jun 2021 14:02
Last Modified:	18 Jan 2023 21:37
DOI:	10.5114/aoms/133716
Open Access URL:	https://www.archivesofmedicalscience.com/Postmarke...
Related URLs:	Author Publisher
URI:	https://livrepository.liverpool.ac.uk/id/eprint/3128287