{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T19:50:30Z","timestamp":1790970630386,"version":"4.1.0"},"reference-count":0,"publisher":"Termedia Sp. z.o.o.","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Arch Med Sci"],"abstract":"Introduction<\/jats:title>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.<\/jats:p><\/jats:sec>Material and methods<\/jats:title>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.<\/jats:p><\/jats:sec>Results<\/jats:title>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.<\/jats:p><\/jats:sec>Conclusions<\/jats:title>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\u2019s labelling.<\/jats:p><\/jats:sec>","DOI":"10.5114\/aoms\/190111","type":"journal-article","created":{"date-parts":[[2024,6,16]],"date-time":"2024-06-16T10:57:54Z","timestamp":1718535474000},"source":"Crossref","is-referenced-by-count":4,"title":["2024 Update on Postmarketing Nutrivigilance Safety Profile: A Line of Dietary Food Supplements Containing Red Yeast Rice for Dyslipidemia."],"prefix":"10.5114","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6690-6874","authenticated-orcid":false,"given":"Maciej","family":"Banach","sequence":"first","affiliation":[{"name":"Department of Preventive Cardiology and Lipidology, Medical University of Lodz (MUL), Lodz, Poland, Poland"},{"name":"Department of Cardiology and Adult Congenital Heart Diseases, Polish Mother\u2019s Memorial Hospital Research Institute (PMMHRI), Lodz, Poland, Poland"},{"name":"Cardiovascular Research Centre, University of Zielona Gora, Zielona Gora, Poland, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0894-2644","authenticated-orcid":false,"given":"Niki","family":"Katsiki","sequence":"additional","affiliation":[{"name":"Department of Nutritional Sciences and Dietetics, International Hellenic University, Thessaloniki, Greece, Greece"},{"name":"School of Medicine, European University Cyprus, Nicosia, Cyprus, Cyprus"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1322-7920","authenticated-orcid":false,"given":"Gustavs","family":"Latkovskis","sequence":"additional","affiliation":[{"name":"Institute of Cardiology and Regenerative Medicine, Faculty of Medicine, University of Latvia, Riga, Latvia, Latvia"},{"name":"Pauls Stradins Clinical University Hospital, Riga, Latvia, Latvia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0320-6779","authenticated-orcid":true,"given":"Dan","family":"Gaita","sequence":"additional","affiliation":[{"name":"Department of Cardiology, \"Victor Babes\" University of Medicine and Pharmacy, Timisoara, Romania, Romania"},{"name":"Institutul de Boli Cardiovasculare, Timisoara, Romania, Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5584-4735","authenticated-orcid":false,"given":"Carlos","family":"Escobar","sequence":"additional","affiliation":[{"name":"Cardiology Department, Hospital Universitario La Paz, Madrid, Spain, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9999-6271","authenticated-orcid":false,"given":"Daniel","family":"Pella","sequence":"additional","affiliation":[{"name":"2nd Department of Cardiology of the East Slovak Institute of Cardiovascular Disease and Faculty of Medicine PJ Safarik University, Kosice, Slovak Republic, Slovak Republic"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6763-1489","authenticated-orcid":true,"given":"Peter E","family":"Penson","sequence":"additional","affiliation":[{"name":"School of Pharmacy and Biomolecular Sciences, Liverpool John Moores University, Liverpool, UK, United Kingdom"},{"name":"Liverpool Centre for Cardiovascular Science, Liverpool, UK, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7853-0042","authenticated-orcid":false,"given":"Federica","family":"Fogacci","sequence":"additional","affiliation":[{"name":"Hypertension and Cardiovascular Risk Factors Research Center, Medical and Surgical Sciences Department, Sant'Orsola-Malpighi University Hospital, Bologna, Italy, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4932-4212","authenticated-orcid":false,"given":"\u017deljko","family":"Reiner","sequence":"additional","affiliation":[{"name":"Department of Cardiology and Adult Congenital Heart Diseases, Polish Mother\u2019s Memorial Hospital Research Institute (PMMHRI), Lodz, Poland, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4367-3884","authenticated-orcid":false,"given":"Arrigo FG","family":"Cicero","sequence":"additional","affiliation":[{"name":"Hypertension and Cardiovascular Risk Factors Research Center, Medical and Surgical Sciences Department, Sant'Orsola-Malpighi University Hospital, Bologna, Italy, Italy"},{"name":"Cardiovascular Medicine Unit, Heart, Thoracic and Vascular Department, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy., Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"3061","published-online":{"date-parts":[[2024,6,16]]},"container-title":["Archives of Medical Science"],"original-title":[],"link":[{"URL":"https:\/\/www.archivesofmedicalscience.com\/pdf-190111-111258","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.archivesofmedicalscience.com\/pdf-190111-111258","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,6,16]],"date-time":"2024-06-16T10:57:55Z","timestamp":1718535475000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.archivesofmedicalscience.com\/2024-Update-on-Postmarketing-Nutrivigilance-Safety-Profile-A-Line-of-Dietary-Food,190111,0,2.html"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,6,16]]},"references-count":0,"alternative-id":["190111"],"URL":"https:\/\/doi.org\/10.5114\/aoms\/190111","relation":{},"ISSN":["1734-1922","1896-9151"],"issn-type":[{"value":"1734-1922","type":"print"},{"value":"1896-9151","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,6,16]]}}}