PMID- 34336013 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220425 IS - 1734-1922 (Print) IS - 1896-9151 (Electronic) IS - 1734-1922 (Linking) VI - 17 IP - 4 DP - 2021 TI - Postmarketing nutrivigilance safety profile: a line of dietary food supplements containing red yeast rice for dyslipidemia. PG - 856-863 LID - 10.5114/aoms/133716 [doi] AB - 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 1(st) October 2004 to 31(st) 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. CI - Copyright: (c) 2021 Termedia & Banach. FAU - Banach, Maciej AU - Banach M AD - Polish Mother's Memorial Hospital Research Institute (PMMHRI), Lodz, Poland. AD - Department of Hypertension, Medical University of Lodz (MUL), Lodz, Poland. AD - Cardiovascular Research Centre, University of Zielona Gora, Zielona Gora, Poland. FAU - Katsiki, Niki AU - Katsiki N AD - First Department of Internal Medicine, Diabetes Center, Division of Endocrinology and Metabolism, Medical School, Aristotle University of Thessaloniki, AHEPA Hospital, Thessaloniki, Greece. FAU - Latkovskis, Gustavs AU - Latkovskis G AD - Institute of Cardiology and Regenerative Medicine, Faculty of Medicine, University of Latvia, Riga, Latvia. AD - Pauls Stradins Clinical University Hospital, Riga, Latvia. FAU - Rizzo, Manfredi AU - Rizzo M AD - Department of Health Promotion Sciences Maternal and Infantile Care, Internal Medicine and Medical Specialties (PROMISE), University of Palermo, Palermo, Italy. FAU - Pella, Daniel AU - Pella D AD - 2 Department of Cardiology of the East Slovak Institute of Cardiovascular Disease and Faculty of Medicine PJ Safarik University, Kosice, Slovak Republic. FAU - Penson, Peter E AU - Penson PE AD - School of Pharmacy and Biomolecular Sciences, Liverpool John Moores University, Liverpool, UK. AD - Liverpool Centre for Cardiovascular Science, Liverpool, UK. FAU - Reiner, Zeljko AU - Reiner Z AD - Department of Internal Medicine, University Hospital Center Zagreb, Zagreb, Croatia. FAU - Cicero, Arrigo F G AU - Cicero AFG AD - IRCCS Azienda Ospedaliero-Universitaria Di Bologna, Bologna, Italy. AD - Alma Mater Studiorum University of Bologna, Bologna, Italy. LA - eng PT - Journal Article DEP - 20210304 PL - Poland TA - Arch Med Sci JT - Archives of medical science : AMS JID - 101258257 PMC - PMC8314417 OTO - NOTNLM OT - adverse event OT - dyslipidaemia OT - nutrivigilance OT - red yeast rice OT - supplement COIS- 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. EDAT- 2021/08/03 06:00 MHDA- 2021/08/03 06:01 PMCR- 2021/03/04 CRDT- 2021/08/02 05:59 PHST- 2021/02/14 00:00 [received] PHST- 2021/02/26 00:00 [accepted] PHST- 2021/08/02 05:59 [entrez] PHST- 2021/08/03 06:00 [pubmed] PHST- 2021/08/03 06:01 [medline] PHST- 2021/03/04 00:00 [pmc-release] AID - 133716 [pii] AID - 10.5114/aoms/133716 [doi] PST - epublish SO - Arch Med Sci. 2021 Mar 4;17(4):856-863. doi: 10.5114/aoms/133716. eCollection 2021.