Banach Maciej, Katsiki Niki, Latkovskis Gustavs, Gaita Dan, Escobar Carlos, Pella Daniel, Penson Peter E, Fogacci Federica, Reiner Zeljko, Cicero Arrigo F G
Department of Preventive Cardiology and Lipidology, Medical University of Lodz (MUL), Lodz, Poland.
Department of Cardiology and Adult Congenital Heart Diseases, Polish Mother's Memorial Hospital Research Institute (PMMHRI), Lodz, Poland.
Arch Med Sci. 2024 Jun 16;21(3):729-737. doi: 10.5114/aoms/190111. eCollection 2025.
Considering lack 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 (AEs) to secure a high level of product safety. This paper updates 2021 results of the use of a nutrivigilance system (which contained data to the end of 2019) in monitoring the incidence of spontaneously reported suspected AEs associated with red yeast rice (RYR) containing food supplements.
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 October 2004 to 31 December 2023, this system captured cases of suspected adverse reactions spontaneously reported by consumers, healthcare professionals, health authorities, regardless of causality.
The total number of case reports received mentioning the RYR food supplement product line increased to 1186, in which 1904 adverse events (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% of exposed consumers) included suspected serious adverse events (SAEs). After very careful investigation, 9 cases (0.0002% of consumers exposed) 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.
This updated nutrivigilance-derived data analysis confirms a very low incidence of suspected AEs associated with the RYR 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 labelling. Changes to the exposed population may impact the reporting rates.
鉴于缺乏欧洲标准化的上市后食品补充剂监测系统（营养监测），一些成员国和公司已制定各自的方法来监测潜在的不良反应（AE），以确保产品的高安全性。本文更新了2021年使用营养监测系统（其中包含截至2019年底的数据）监测含红曲米（RYR）食品补充剂自发报告的疑似AE发生率的结果。
我们报告了一款以商标Armolipid/Armolipid Plus销售的广泛使用产品的数据。上市后信息是在制造商（意大利蒙扎的威朗制药公司旗下的Meda Pharma SpA）建立的自愿营养监测系统中收集的。从2004年10月1日至2023年12月31日，该系统捕获了消费者、医疗保健专业人员、卫生当局自发报告的疑似不良反应病例，无论因果关系如何。
提及RYR食品补充剂产品线的病例报告总数增加到1186份，其中报告了1904起不良事件（AE）。AE的总报告率估计为3880865名暴露消费者的0.049%。在1186例病例中，28例（占暴露消费者的0.0007%）包括疑似严重不良事件（SAE）。经过非常仔细的调查，制造商评估9例（占暴露消费者的0.0002%）和12起AE为严重且可能与接触上述基于RYR的营养保健品有关。与之前的分析相比，观察到与新引入的70岁年龄限制相关的超说明书报告。
这次更新的基于营养监测的数据分析证实，与RYR产品线相关的疑似AE发生率非常低。通过提高对遵循食品补充剂标签中详细说明的适应症和警告重要性的认识，食品补充剂的消费者安全性通常可以得到提高。暴露人群的变化可能会影响报告率。
