Botanicals and Plant Food Supplements (PFS) have received an increasing interest in the last decades. Although these products are intended to improve physiological functions, concerns about their safety have been raised. To collect new information about the risk associated with PFS consumption, different activities were performed during the EU project PlantLIBRA: (1) a critical review of the adverse effects described in published case reports and human clinical studies; (2) a multicentre retrospective study involving the European Poison Centres; (3) the assessment of adverse effects self-reported by people participating to the PlantLIBRA PFS consumer survey. The results were integrated with recent data on adverse effects collected by the Pavia Poison Centre, ANSES and FDA. According to PlantLIBRA results and the new collected data, Valeriana officinalis and Camellia sinensis are the plants most frequently involved in adverse effects in Europe. Data from FDA showed that Silybum marianum and Serenoa repens are the most cited in US. Although most case reports showed minor symptomatology, some severe events occurred, including fatalities. Symptoms involved mainly liver, gastrointestinal and nervous systems. Generally speaking, the high variability found in the quality of reports determined a significant reduction of the number of cases assessable, since the causality between a specific botanical (or its derivative) and the adverse effect was not always scientifically supported.

The Other Face of the Moon: Side Effects,Interactions and Molecules of Concerns / C.M. DI LORENZO, D. Aymeric, V. Sarah, L. Saskia, F. Colombo, O. Francesca, P. Restani - In: Food Supplements Containing Botanicals: Benefits, Side Effects and Regulatory Aspects : The Scientific Inheritance of the EU Project PlantLIBRA / [a cura di] P. Restani. - Prima edizione. - [s.l] : Springer International, 2018 Dec. - ISBN 9783319622286. - pp. 141-176

The Other Face of the Moon: Side Effects,Interactions and Molecules of Concerns

C.M. DI LORENZO;F. Colombo;P. Restani
2018-12

Abstract

Botanicals and Plant Food Supplements (PFS) have received an increasing interest in the last decades. Although these products are intended to improve physiological functions, concerns about their safety have been raised. To collect new information about the risk associated with PFS consumption, different activities were performed during the EU project PlantLIBRA: (1) a critical review of the adverse effects described in published case reports and human clinical studies; (2) a multicentre retrospective study involving the European Poison Centres; (3) the assessment of adverse effects self-reported by people participating to the PlantLIBRA PFS consumer survey. The results were integrated with recent data on adverse effects collected by the Pavia Poison Centre, ANSES and FDA. According to PlantLIBRA results and the new collected data, Valeriana officinalis and Camellia sinensis are the plants most frequently involved in adverse effects in Europe. Data from FDA showed that Silybum marianum and Serenoa repens are the most cited in US. Although most case reports showed minor symptomatology, some severe events occurred, including fatalities. Symptoms involved mainly liver, gastrointestinal and nervous systems. Generally speaking, the high variability found in the quality of reports determined a significant reduction of the number of cases assessable, since the causality between a specific botanical (or its derivative) and the adverse effect was not always scientifically supported.
Botanicals; Plant Food Supplements; Adverse effects; Phytovigilance; European Poison Centres; ANSES; FDA
Settore CHIM/10 - Chimica degli Alimenti
Plant food supplements: Levels of Intake, Benefit and Risk Assessment
Book Part (author)
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/2434/542960
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