Adverse reactions to dietary supplements containing red yeast rice: assessment of cases from the Italian surveillance system.

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 wer

SUBMITTER: Mazzanti G 

PROVIDER: S-EPMC5346868 | biostudies-literature | 2017 Apr

REPOSITORIES: biostudies-literature