Rheum rhaponticum Extract (ERr 731): Postmarketing Data on Safety Surveillance and Consumer Complaints.

Context: Postmarketing surveillance data for a commercially available extract of Rheum rhaponticum (ERr 731) have not been published since the beginning of the reporting in 1993 in Germany about adverse events (AEs) that were believed to be associated with it. The extract is derived from the plant's roots and is indicated for menopausal relief. In Germany, the extract has been marketed as Phytoestrol N and other related products-Phyto-Strol, Phyto-Strol Loges, and Phyto-Strol compact and as femi-loges. In the United States and Canada and in South Africa, the product had been marketed as Estrovera.

Objective: The study's objective was to summarize the AE reports from Germany from 1993 to June 2014 and also to assess consumers' complaints in North America and South Africa from the date of the extract's launch to June 2014.

Design: AE reports recorded by 2 German holders of marketing authorizations, Chemisch-Pharmazeutische Fabrik Göppingen, for Phytoestrol N, and Dr. Loges + Co. GmbH, for femi-loges, were collected and analyzed. Consumers' complaints in North America and South Africa that had been captured by the US distributor of Estrovera were also collected and analyzed.

Results: From 1993 to June 2014, approximately 140 million daily doses of the extract were placed on the German market, and 124 AE reports were recorded. The most common of those AEs were hypersensitivity, with 74 reactions, and gastrointestinal symptoms, with 47 reactions. From January 2009 to June 2014, approximately 13 million tablets of the supplement were sold in North America, and 79 complaints from consumers associated with a physical response to it had been recorded. The main complaints were gastrointestinal symptoms, with 23 cases, and failure to work as suggested, with 22 cases. From the date of the product's launch in South Africa in February 2011 to June 2014, no consumer complaints have been reported.

Conclusions: The records related to postmarketing surveillance and consumers' complaints suggest that the extract of R rhaponticum is generally safe for consumption.