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. 2021 Mar 4;17(4):856-863.
doi: 10.5114/aoms/133716. eCollection 2021.

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

Maciej Banach  1   2   3 , Niki Katsiki  4 , Gustavs Latkovskis  5   6 , Manfredi Rizzo  7 , Daniel Pella  8 , Peter E Penson  9   10 , Zeljko Reiner  11 , Arrigo F G Cicero  12   13
Affiliations

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

Maciej Banach et al. Arch Med Sci. .

Abstract

Introduction: 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).

Material and methods: 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 1st October 2004 to 31st December 2019, this system captured cases of suspected adverse reactions spontaneously reported by consumers, healthcare professionals, health authorities, regardless of causality.

Results: 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.

Conclusions: 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.

Keywords: adverse event; dyslipidaemia; nutrivigilance; red yeast rice; supplement.

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Conflict of interest statement

Dr Banach has received research grant(s)/support from Amgen, Mylan, Sanofi and Valeant, and has served as a speaker and consultant for Amgen, Daichii Sankyo, Esperion, Freia Pharmaceuticals, Herbapol, Kogen, KRKA, Mylan, Novartis, Novo Nordisk, Polpharma, Polfarmex, Regeneron, Sanofi-Aventis, Servier, Zentiva; Dr Katsiki has given talks, attended conferences and participated in trials sponsored by Astra Zeneca, Bausch Health, Boehringer Ingelheim, Elpen, Menarini, Mylan, Novo Nordisk, Sanofi, Servier and Vianex; Dr. Latkovskis reports grants, honoraria or non-financial support from Abbott Laboratories, Amgen, Astra-Zeneca, Bayer, Berlin-Chemie/Menarini, Boehringer Ingelheim, GlaxoSmithKline, KRKA, Mylan, Novartis, Novo Nordisk, Pfizer, Roche Diagnostics, Sanofi-Aventis, Servier, Siemens Healthcare, Zentiva; Dr Rizzo has given lectures, received honoraria and research support, and participated in conferences, advisory boards and clinical trials sponsored by many pharmaceutical companies including Amgen, AstraZeneca, Boehringer Ingelheim, Kowa, Eli Lilly, Meda, Merck Sharp & Dohme, Mylan, Novo Nordisk, Novartis, Roche Diagnostics, Sanofi and Servier; he is currently Medical Director, Novo Nordisk BA LM; Dr Penson owns four shares in AstraZeneca PLC and has received honoraria and/or travel reimbursement for events sponsored by AKCEA, Amgen, AMRYT, Link Medical, Napp and Sanofi; Dr Reiner has received honoraria from Sanofi and Novartis. Dr Cicero is a scientific consultant for Meda-Mylan SpA, Sharper SpA and Menarini IFR; Dr Pella has nothing to declare.

Figures

Figure 1
Figure 1
Adverse events on millions of exposed consumers
See this image and copyright information in PMC

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