Analysis of surveillance data assessing safety of ERr 731®, a standardized extract of Rheum rhaponticum indicated for menopausal relief was published in a recent peer-reviewed journal
ERr 731, a standardized extract from the roots of Siberian rhubarb (Rheum rhaponticum), has been used in Germany since 1993 as an alternative for women considering nonhormonal approach to managing menopausal symptoms. It was introduced as a dietary supplement in 2009 in the U.S., in 2012 in Canada, and in 2011 in South Africa.
As per regulations in Germany, the marketing authorization holders have been collecting and documenting adverse events (AEs) that are suspected to be associated with the consumption of ERr 731. These AE reports were recently summarized and assessed, and the results have been published in the June/July 2016 issue of Integrative Medicine: A Clinician’s Journal (IMCJ).
The article found that, between July 1993 and June 2014, 124 AEs had been reported in Germany. During the same period, approximately 140 million daily doses of ERr 731 were placed on the market. On average, 6.7 million doses of ERr 731 were sold annually, and 5.9 AE reports per year were recorded. The most common of those AEs were hypersensitivity/rash and gastrointestinal symptoms, accounted for 34.4% and 21.9%, respectively, of all the AE reports.
In North America and South Africa, consumers’ complaints that have been related to the consumption of ERr 731 have been actively documented by its distributor since the product’s launch. These complaints included suspected AEs reported by health care professionals. These data also have been reported in the same published article.
From January 2009 to June 2014, approximately 13 million tablets of ERr 731 had been sold in North America, and 79 consumer complaints postconsumption had been recorded. On average, 2.4 million doses of the extract were sold annually, and 14.6 complaints from consumers per year were documented. The main complaints were gastrointestinal symptoms and failure to work as suggested, accounted for 29.1% and 27.8%, respectively, of all the complaints. No consumer complaints have been reported in South Africa.
These data showed that the incidence of AEs or consumer complaints can be considered to be very low; therefore, the extract was safe for most users. However, a major limitation of postmarketing surveillance is underreporting. Thus, data should be interpreted with caution.
The article, titled “Rheum rhaponticum Extract (ERr 731): Postmarketing Data on Safety Surveillance and Consumer Complaints”, is currently available for purchase at the journal’s website www.imjournal.com. The first page of the article, including the abstract, can be previewed at https://www.scribd.com/doc/316444404/Rheum-rhaponticum-Extract-ERr-731-Postmarketing-Data-on-Safety-Surveillance-and-Consumer-Complaints.