Pharmacologically effective red yeast rice preparations marketed as dietary supplements illustrated by a case report

Drug Testing and Analysis
Bastiaan VenhuisDries de Kaste

Abstract

This paper reports a typical statin-related adverse reaction from a red yeast rice (RYR) supplement and the analytical findings from the supplement. It also examines the regulatory framework governing botanical supplements in Europe. Two key events that shaped the current regulatory framework are reviewed. First, the Hecht-Pharma judgement by the European Court of Justice (ECJ) that inverted the precautionary principle in the Medicines Act to a reactionary principle. Following the Hecht-Pharma judgement, pharmacological active dietary supplements can be sold until sufficient signals of harm show that they are an unregistered medicine, placing a huge burden on regulatory authorities. Secondly, the European Food Safety Authority (EFSA) in 2011 approved the first health claim for pharmacologically active RYR dietary supplements. If the current regulatory status for pharmacologically active RYR dietary supplements does not permit adequate warning and active monitoring of adverse drug reactions, then the current regulatory framework may not be adequate to ensure consumer safety.Copyright © 2016 John Wiley & Sons, Ltd.

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Citations

Oct 28, 2016·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Antonello SantiniEttore Novellino
Mar 4, 2017·Foods·Thu NguyenAntonello Santini
Feb 13, 2018·British Journal of Clinical Pharmacology·Antonello SantiniEttore Novellino
Mar 31, 2018·Current Medicinal Chemistry·Robert HromadkaVladimir Kral
Aug 3, 2018·EFSA Journal·UNKNOWN EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS)Matthew Wright
May 30, 2019·Molecules : a Journal of Synthetic Chemistry and Natural Product Chemistry·Jiawen SongXiaofang Li
Mar 18, 2021·Praxis·Monika RauBeat Knechtle

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