title: Pharmacologically effective red yeast rice preparations marketed as dietary supplements illustrated by a case report.
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.
authors.affiliation: National Institute for Public Health and the Environment RIVM, A. van Leeuwenhoeklaan 9, 3721MA, Bilthoven, The Netherlands.
authors.forename: B J
authors.initials: BJ
authors.lastname: Venhuis
authors.affiliation: Netherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 9, 5237 MH, 's-Hertogenbosch, The Netherlands.
authors.forename: F
authors.initials: F
authors.lastname: van Hunsel
authors.affiliation: Netherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 9, 5237 MH, 's-Hertogenbosch, The Netherlands.
authors.forename: S
authors.initials: S
authors.lastname: van de Koppel
authors.affiliation: National Institute for Public Health and the Environment RIVM, A. van Leeuwenhoeklaan 9, 3721MA, Bilthoven, The Netherlands.
authors.forename: P H J
authors.initials: PH
authors.lastname: Keizers
authors.affiliation: National Institute for Public Health and the Environment RIVM, A. van Leeuwenhoeklaan 9, 3721MA, Bilthoven, The Netherlands.
authors.forename: S M F
authors.initials: SM
authors.lastname: Jeurissen
authors.affiliation: National Institute for Public Health and the Environment RIVM, A. van Leeuwenhoeklaan 9, 3721MA, Bilthoven, The Netherlands.
authors.forename: D
authors.initials: D
authors.lastname: De Kaste
mesh_terms: D001688:Biological Products / Q000008:administration & dosage / Q000009:adverse effects* / Q000737:chemistry; D019587:Dietary Supplements / Q000009:adverse effects*; D004335:Drug and Narcotic Control; D005062:European Union; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects*; D008148:Lovastatin / Q000008:administration & dosage / Q000009:adverse effects*; D008875:Middle Aged
chemical_list: D001688:Biological Products; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; C117343:red yeast rice; D008148:Lovastatin
keywords: Medicines Act; Monacolin K; adverse events; lovastatin; myalgia; red yeast rice; regulatory status; unregistered medicine