Centro Nazionale per la Ricerca e la Valutazione Preclinica e Clinica dei Farmaci, Istituto Superiore di Sanità, Rome, Italy.
Dipartimento Sicurezza Alimentare, Nutrizione e Sanità Pubblica Veterinaria, Istituto Superiore di Sanità, Rome, Italy.
Ann Ist Super Sanita. 2020 Oct-Dec;56(4):462-469. doi: 10.4415/ANN_20_04_08.
Turmeric is the common name for the rhizome of Curcuma longa L. In the recent years, food supplements containing turmeric have been marketed and widely used by an increasing number of consumers. Spontaneous reports of suspected adverse reactions to food supplements are collected within the Phytovigilance system.
An ad hoc multidisciplinary group investigated the suspected cases of hepatotoxicity reported to the Italian Phytovigilance system associated with the assumption of turmeric food supplements with the methodology specific to pharmacovigilance as well as for the evaluation of the quality and safety of food supplements.
A cluster of 28 spontaneous reports of acute hepatitis, mostly with cholestasis, associated with turmeric products were sent to the Italian Phytovigilance system in the first six months of 2019. In all cases, except one, the causality assessment was at least possible. The suspected products were collected and analysed for the presence of drugs, heavy metals, aflatoxins, pesticides, synthetic dyes and pyrrolizidine alkaloids.
On the basis of the results of all the activities performed by multidisciplinary group, regulatory intervention was taken. This study highlights the importance of developing an integrated evaluation approach for the evaluation of the adverse effects associated with the use of food supplements.
姜黄是姜黄属植物的根茎的通用名称。近年来，含有姜黄的食品补充剂已在市场上销售，并被越来越多的消费者广泛使用。自发报告的疑似不良反应食品补充剂收集在植物监督系统内。
一个特设的多学科小组调查了与食用姜黄食品补充剂相关的疑似肝毒性报告，使用了专门的药物监测方法，以及对食品补充剂的质量和安全性进行评估。
2019 年头六个月，意大利植物监督系统共收到 28 份与姜黄产品相关的急性肝炎的自发报告，大多伴有胆汁淤积。在所有病例中，除了一个病例外，因果关系评估至少是可能的。可疑产品被收集并分析是否存在药物、重金属、黄曲霉毒素、农药、合成染料和吡咯里西啶生物碱。
根据多学科小组进行的所有活动的结果，已采取监管干预措施。本研究强调了开发综合评估方法来评估与食品补充剂使用相关的不良影响的重要性。
