PMID- 29582393
OWN - NLM
STAT- MEDLINE
DCOM- 20181106
LR  - 20181114
IS  - 1179-1942 (Electronic)
IS  - 0114-5916 (Linking)
VI  - 41
IP  - 8
DP  - 2018 Aug
TI  - Adverse Events to Food Supplements Containing Red Yeast Rice: Comparative 
      Analysis of FAERS and CAERS Reporting Systems.
PG  - 745-752
LID - 10.1007/s40264-018-0661-3 [doi]
AB  - INTRODUCTION: Food supplements containing red yeast rice (RYR) are proposed as an 
      alternative in statin-intolerant patients, although they actually contain natural 
      statin(s) and their safety in clinical practice is still incompletely 
      characterized. We described and compared adverse events (AEs) associated with RYR 
      products submitted to reporting systems maintained by the Food and Drug 
      Administration (FDA), with a focus on liver and muscular events. METHODS: We 
      extracted RYR-related AEs from the FDA Adverse Event Reporting System (FAERS) 
      [first quarter (Q1)-2004 to Q2-2016], a drug-based archive, and the Center for 
      Food Safety and Applied Nutrition Adverse Event Reporting System (CAERS) (Q1-2004 
      to Q1-2017). Disproportionality via reporting odds ratio (ROR) with 95% 
      confidence interval (CI) calculation and case-by-case inspection were performed, 
      with a focus on muscular and hepatic AEs. RESULTS: One thousand three hundred AEs 
      were extracted from FAERS (RYR mainly reported as a concomitant agent), whereas 
      only 159 AEs were found in CAERS (RYR recorded mainly as a suspect agent). 
      In FAERS, a large number of reports emerged for "general disorders and 
      administration site conditions," whereas CAERS received also a high number of 
      reports for "investigations" and "musculoskeletal and connective tissue 
      disorders". Disproportionality analyses confirmed higher reporting of serious 
      muscular and liver injuries: in FAERS, five cases of hepatic disorders 
      (ROR = 13.71; 95% CI 5.44-34.57); in CAERS, 27 cases of rhabdomyolysis/myopathy 
      (8.44; 5.44-13.10). CONCLUSIONS: Notwithstanding recognized limitations, these 
      findings strengthen the importance of exploring multiple databases in safety 
      assessment of RYR products, which should be monitored by clinicians for muscular 
      and hepatic safety, and call for urgent review by policymakers to harmonize their 
      regulatory status.
FAU - Raschi, Emanuel
AU  - Raschi E
AUID- ORCID: 0000-0003-0487-7996
AD  - Pharmacology Unit, Department of Medical and Surgical Sciences, Alma Mater 
      Studiorum - University of Bologna, Via Irnerio 48, 40126, Bologna, BO, Italy. 
      emanuel.raschi@unibo.it.
FAU - Girardi, Anna
AU  - Girardi A
AD  - Pharmacology Unit, Department of Medical and Surgical Sciences, Alma Mater 
      Studiorum - University of Bologna, Via Irnerio 48, 40126, Bologna, BO, Italy.
FAU - Poluzzi, Elisabetta
AU  - Poluzzi E
AD  - Pharmacology Unit, Department of Medical and Surgical Sciences, Alma Mater 
      Studiorum - University of Bologna, Via Irnerio 48, 40126, Bologna, BO, Italy.
FAU - Forcesi, Emanuele
AU  - Forcesi E
AD  - Pharmacology Unit, Department of Medical and Surgical Sciences, Alma Mater 
      Studiorum - University of Bologna, Via Irnerio 48, 40126, Bologna, BO, Italy.
FAU - Menniti-Ippolito, Francesca
AU  - Menniti-Ippolito F
AD  - National Centre for Drug Research and Evaluation, National Institute of Health, 
      Viale Regina Elena 299, 00161, Rome, Italy.
FAU - Mazzanti, Gabriela
AU  - Mazzanti G
AD  - Department of Physiology and Pharmacology "Vittorio Erspamer", Sapienza 
      University of Rome, Piazzale Aldo Moro 5, 00185, Rome, Italy.
FAU - De Ponti, Fabrizio
AU  - De Ponti F
AD  - Pharmacology Unit, Department of Medical and Surgical Sciences, Alma Mater 
      Studiorum - University of Bologna, Via Irnerio 48, 40126, Bologna, BO, Italy.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - New Zealand
TA  - Drug Saf
JT  - Drug safety
JID - 9002928
RN  - 0 (Biological Products)
RN  - 0 (red yeast rice)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Adverse Drug Reaction Reporting Systems/*standards
MH  - Aged
MH  - Biological Products/*adverse effects
MH  - Child
MH  - Child, Preschool
MH  - Dietary Supplements/*adverse effects
MH  - Female
MH  - *Food Safety/methods
MH  - Humans
MH  - Infant
MH  - Infant, Newborn
MH  - Male
MH  - Middle Aged
MH  - Product Surveillance, Postmarketing/methods/standards
MH  - United States/epidemiology
MH  - United States Food and Drug Administration/*standards
MH  - Young Adult
EDAT- 2018/03/28 06:00
MHDA- 2018/11/07 06:00
CRDT- 2018/03/28 06:00
PHST- 2018/03/28 06:00 [pubmed]
PHST- 2018/11/07 06:00 [medline]
PHST- 2018/03/28 06:00 [entrez]
AID - 10.1007/s40264-018-0661-3 [pii]
AID - 10.1007/s40264-018-0661-3 [doi]
PST - ppublish
SO  - Drug Saf. 2018 Aug;41(8):745-752. doi: 10.1007/s40264-018-0661-3.