Gabriela Mazzanti1, Paola Angela Moro2, Emanuel Raschi3, Roberto Da Cas4, Francesca Menniti-Ippolito4. 1. Department of Physiology and Pharmacology 'Vittorio Erspamer', Sapienza University of Rome, Piazzale Aldo Moro 5, 00185, Rome, Italy. 2. Poison Control Center, Niguarda Ca' Grande Hospital, Piazza Ospedale Maggiore 3, 20162, Milan, Italy. 3. Pharmacology Unit, Department of Medical and Surgical Sciences, University of Bologna, Via Irnerio 48, 40126, Bologna, Italy. 4. Centre for Epidemiology, National Institute of Health, Viale Regina Elena 299, 00161, Rome, Italy.
Abstract
AIMS: Red yeast rice (RYR) is contained in dietary supplements for patients with dyslipidemia. RYR supplements contain monacolin K, which is chemically identical to lovastatin, a licensed drug with a well-known risk profile. We aim to describe the safety profile of RYR by analysing spontaneous reports of suspected adverse reactions (ARs). METHODS: Within the Italian Surveillance System of Natural Health Products, suspected ARs were collected and evaluated by a multidisciplinary group of experts to assess causality using the WHO-UMC system or the CIOMS/RUCAM score, for hepatic reactions. The public version of the WHO-Vigibase was also queried. RESULTS: From April 2002 to September 2015, out of 1261 total reports, 52 reports concerning 55 ARs to RYR dietary supplements were collected. ARs consisted in myalgia and/or increase in creatine phosphokinase (19), rhabdomyolysis (1), liver injury (10), gastrointestinal reactions (12), cutaneous reactions (9) and other reactions (4). Women were involved in 70% of cases. In 13 cases, the reaction required hospitalization, and 28 patients were taking other medications. Dechallenge was positive in 40 reactions (73%), rechallenge was positive in 7. Causality resulted as certain (1), probable (31, 56%), possible (18, 34%), unlikely (3) or unassessable (2). Similar distribution emerged from the WHO-Vigibase. CONCLUSIONS: The potential safety signals of myopathies and liver injury raise the hypothesis that the safety profile of RYR is similar to that of statins. Continuous monitoring of dietary supplements should be promoted to finally characterize their risk profile, thus supporting regulatory bodies for appropriate actions.
AIMS: Red yeastrice (RYR) is contained in dietary supplements for patients with dyslipidemia. RYR supplements contain monacolin K, which is chemically identical to lovastatin, a licensed drug with a well-known risk profile. We aim to describe the safety profile of RYR by analysing spontaneous reports of suspected adverse reactions (ARs). METHODS: Within the Italian Surveillance System of Natural Health Products, suspected ARs were collected and evaluated by a multidisciplinary group of experts to assess causality using the WHO-UMC system or the CIOMS/RUCAM score, for hepatic reactions. The public version of the WHO-Vigibase was also queried. RESULTS: From April 2002 to September 2015, out of 1261 total reports, 52 reports concerning 55 ARs to RYR dietary supplements were collected. ARs consisted in myalgia and/or increase in creatine phosphokinase (19), rhabdomyolysis (1), liver injury (10), gastrointestinal reactions (12), cutaneous reactions (9) and other reactions (4). Women were involved in 70% of cases. In 13 cases, the reaction required hospitalization, and 28 patients were taking other medications. Dechallenge was positive in 40 reactions (73%), rechallenge was positive in 7. Causality resulted as certain (1), probable (31, 56%), possible (18, 34%), unlikely (3) or unassessable (2). Similar distribution emerged from the WHO-Vigibase. CONCLUSIONS: The potential safety signals of myopathies and liver injury raise the hypothesis that the safety profile of RYR is similar to that of statins. Continuous monitoring of dietary supplements should be promoted to finally characterize their risk profile, thus supporting regulatory bodies for appropriate actions.
Authors: Ji Young Lee; Seung Ah Jun; Sung Shin Hong; Yo Chan Ahn; Dong Soo Lee; Chang Gue Son Journal: Phytother Res Date: 2016-05-16 Impact factor: 5.878
Authors: Arrigo F G Cicero; Alessandro Colletti; Gani Bajraktari; Olivier Descamps; Dragan M Djuric; Marat Ezhov; Zlatko Fras; Niki Katsiki; Michel Langlois; Gustavs Latkovskis; Demosthenes B Panagiotakos; Gyorgy Paragh; Dimitri P Mikhailidis; Olena Mitchenko; Bernhard Paulweber; Daniel Pella; Christos Pitsavos; Željko Reiner; Kausik K Ray; Manfredi Rizzo; Amirhossein Sahebkar; Maria-Corina Serban; Laurence S Sperling; Peter P Toth; Dragos Vinereanu; Michal Vrablík; Nathan D Wong; Maciej Banach Journal: Arch Med Sci Date: 2017-08-04 Impact factor: 3.318