{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,19]],"date-time":"2026-08-19T19:39:41Z","timestamp":1787168381263,"version":"build-2736575974"},"reference-count":64,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2017,1,19]],"date-time":"2017-01-19T00:00:00Z","timestamp":1484784000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Brit J Clinical Pharma"],"published-print":{"date-parts":[[2017,4]]},"abstract":"<jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>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\u2010known risk profile. We aim to describe the safety profile of RYR by analysing spontaneous reports of suspected adverse reactions (ARs).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>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\u2010UMC system or the CIOMS\/RUCAM score, for hepatic reactions. The public version of the WHO\u2010Vigibase was also queried.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      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\n                      <jats:italic>certain<\/jats:italic>\n                      (1),\n                      <jats:italic>probable<\/jats:italic>\n                      (31, 56%),\n                      <jats:italic>possible<\/jats:italic>\n                      (18, 34%),\n                      <jats:italic>unlikely<\/jats:italic>\n                      (3) or\n                      <jats:italic>unassessable<\/jats:italic>\n                      (2). Similar distribution emerged from the WHO\u2010Vigibase.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/bcp.13171","type":"journal-article","created":{"date-parts":[[2017,1,17]],"date-time":"2017-01-17T00:03:06Z","timestamp":1484611386000},"page":"894-908","source":"Crossref","is-referenced-by-count":71,"title":["Adverse reactions to dietary supplements containing red yeast rice: assessment of cases from the Italian surveillance system"],"prefix":"10.1111","volume":"83","author":[{"given":"Gabriela","family":"Mazzanti","sequence":"first","affiliation":[{"name":"Department of Physiology and Pharmacology \u2018Vittorio Erspamer\u2019 Sapienza University of Rome  Piazzale Aldo Moro 5 00185 Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paola Angela","family":"Moro","sequence":"additional","affiliation":[{"name":"Poison Control Center Niguarda Ca' Grande Hospital  Piazza Ospedale Maggiore 3 20162 Milan Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0487-7996","authenticated-orcid":false,"given":"Emanuel","family":"Raschi","sequence":"additional","affiliation":[{"name":"Pharmacology Unit, Department of Medical and Surgical Sciences University of Bologna  Via Irnerio 48 40126 Bologna Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roberto","family":"Da Cas","sequence":"additional","affiliation":[{"name":"Centre for Epidemiology National Institute of Health  Viale Regina Elena 299 00161 Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesca","family":"Menniti\u2010Ippolito","sequence":"additional","affiliation":[{"name":"Centre for Epidemiology National Institute of Health  Viale Regina Elena 299 00161 Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2017,1,19]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1093\/nar\/gkv1037"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/bph.13354"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMsa1504267"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.1566"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/ptr.5647"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.fct.2016.07.001"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.12519"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1021\/jf000338c"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-150-12-200906160-00006"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.amjcard.2009.10.045"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacl.2014.09.002"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1093\/ajcn\/69.2.231"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.curtheres.2014.07.003"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.amjcard.2009.08.672"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.amjcard.2015.09.023"},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.1111\/jcpt.12374"},{"key":"e_1_2_11_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacl.2012.09.003"},{"key":"e_1_2_11_19_1","doi-asserted-by":"publisher","DOI":"10.1021\/jf020023s"},{"key":"e_1_2_11_20_1","doi-asserted-by":"publisher","DOI":"10.2478\/10004-1254-60-2009-1992"},{"key":"e_1_2_11_21_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11883-010-0145-0"},{"key":"e_1_2_11_22_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11883-015-0495-8"},{"key":"e_1_2_11_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.atherosclerosis.2015.04.004"},{"key":"e_1_2_11_24_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2125.2008.03224.x"},{"key":"e_1_2_11_25_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2009.02.021"},{"key":"e_1_2_11_26_1","doi-asserted-by":"publisher","DOI":"10.2515\/therapie\/2015053"},{"key":"e_1_2_11_27_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.SMJ.0000100117.79718.DC"},{"key":"e_1_2_11_28_1","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-145-6-200609190-00021"},{"key":"e_1_2_11_29_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1532-5415.2006.00668_7.x"},{"key":"e_1_2_11_30_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacl.2007.12.005"},{"key":"e_1_2_11_31_1","unstructured":"Opinion of the French Agency for Food Environmental and Occupational Health & Safety (ANSES) on the risks associated with the presence of \u2018red yeast rice\u2019 in food supplements. 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