Banach, M, Katsiki, N, Latkovskis, G, Gaita, D, Escobar, C, Pella, D, Penson, PE, Fogacci, F, Reiner, Ž and Cicero, AFG 2024 Update on Postmarketing Nutrivigilance Safety Profile: A Line of Dietary Food Supplements Containing Red Yeast Rice for Dyslipidemia. Archives of Medical Science. ISSN 1734-1922 (Accepted)

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Abstract

Introduction: Considering lack of a European standardized postmarketing food supplement surveillance system, some member states and companies have developed their own approaches to monitoring potential AEs to secure a high level of product safety. This paper updates 2021 results of the use of a nutrivigilance system in monitoring the incidence of spontaneously reported suspected AEs associated with RYR-containing food supplements. Material and methods: We report the data from a 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 2004-31st December 2023, this system captured cases of suspected AEs 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 increased to 1186, in which 1904 AEs were reported. The total reporting rate of AEs was estimated to be 0.049% of 3,880,865 exposed consumers. Of the 1186 cases, 28 (0.0007%) included suspected SAEs. After careful investigation, 9 cases (0.0002%) and 12 AEs were assessed by the manufacturer as serious and potentially related to exposure to the above-mentioned RYR-based nutraceutical. Off-label reports linked to the newly introduced limitation at 70 years of age were observed, in contrast to the previous analysis. Conclusions: These updated results confirm a very low incidence of RYR suspected AEs. 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 labelling.

Item Type:	Article
Additional Information:	Great to deposit. ATDone KJ 9/9/24 Just need to upload the article or link to it with it being OA. Doesn't look published yet as only preprint so leave as accepted and do Trello note to check for published version and to replace. Then deposit. AT Done KJ 9/9/24
Uncontrolled Keywords:	1103 Clinical Sciences; General & Internal Medicine
Subjects:	T Technology > TX Home economics > TX341 Nutrition. Foods and food supply Q Science > QH Natural history > QH301 Biology
Divisions:	Pharmacy & Biomolecular Sciences
Publisher:	Termedia Publishing
SWORD Depositor:	A Symplectic
Date Deposited:	09 Sep 2024 11:55
Last Modified:	09 Sep 2024 14:21
DOI or ID number:	10.5114/aoms/190111
URI:	https://researchonline.ljmu.ac.uk/id/eprint/24095

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