PMID- 27547165
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20160822
LR  - 20200930
IS  - 1546-993X (Print)
IS  - 1945-7081 (Electronic)
IS  - 1546-993X (Linking)
VI  - 15
IP  - 3
DP  - 2016 Jun
TI  - Rheum rhaponticum Extract (ERr 731): Postmarketing Data on Safety Surveillance 
      and Consumer Complaints.
PG  - 34-9
AB  - 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 
      Goppingen, 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.
FAU - Chang, Jyh-Lurn
AU  - Chang JL
AD  - is the manager for medical affairs; and is the senior director of medical affairs 
      at Metagenics, Inc, in Gig Harbor, Washington. is a director at Health Research 
      Services GmbH in Ubstadt-Weiher, Germany. is the qualified person for 
      pharmacovigilance (QPPV) at Dr. Loges + Co. GmbH in Winsen (Luhe), Germany. is a 
      director at Chemisch-Pharmazeutische Fabrik Goppingen, Carl Muller, Apotheker, 
      GmbH & Co KG, in Goppingen, Germany. is medical director and head of the 
      Department of Obstetrics and Gynecology Bruchsal, Teaching Hospital of the 
      University of Heidelberg in Heidelberg, Germany.
FAU - Montalto, Michael B
AU  - Montalto MB
AD  - is the manager for medical affairs; and is the senior director of medical affairs 
      at Metagenics, Inc, in Gig Harbor, Washington. is a director at Health Research 
      Services GmbH in Ubstadt-Weiher, Germany. is the qualified person for 
      pharmacovigilance (QPPV) at Dr. Loges + Co. GmbH in Winsen (Luhe), Germany. is a 
      director at Chemisch-Pharmazeutische Fabrik Goppingen, Carl Muller, Apotheker, 
      GmbH & Co KG, in Goppingen, Germany. is medical director and head of the 
      Department of Obstetrics and Gynecology Bruchsal, Teaching Hospital of the 
      University of Heidelberg in Heidelberg, Germany.
FAU - Heger, Peter W
AU  - Heger PW
AD  - is the manager for medical affairs; and is the senior director of medical affairs 
      at Metagenics, Inc, in Gig Harbor, Washington. is a director at Health Research 
      Services GmbH in Ubstadt-Weiher, Germany. is the qualified person for 
      pharmacovigilance (QPPV) at Dr. Loges + Co. GmbH in Winsen (Luhe), Germany. is a 
      director at Chemisch-Pharmazeutische Fabrik Goppingen, Carl Muller, Apotheker, 
      GmbH & Co KG, in Goppingen, Germany. is medical director and head of the 
      Department of Obstetrics and Gynecology Bruchsal, Teaching Hospital of the 
      University of Heidelberg in Heidelberg, Germany.
FAU - Thiemann, Eva
AU  - Thiemann E
AD  - is the manager for medical affairs; and is the senior director of medical affairs 
      at Metagenics, Inc, in Gig Harbor, Washington. is a director at Health Research 
      Services GmbH in Ubstadt-Weiher, Germany. is the qualified person for 
      pharmacovigilance (QPPV) at Dr. Loges + Co. GmbH in Winsen (Luhe), Germany. is a 
      director at Chemisch-Pharmazeutische Fabrik Goppingen, Carl Muller, Apotheker, 
      GmbH & Co KG, in Goppingen, Germany. is medical director and head of the 
      Department of Obstetrics and Gynecology Bruchsal, Teaching Hospital of the 
      University of Heidelberg in Heidelberg, Germany.
FAU - Rettenberger, Reinhard
AU  - Rettenberger R
AD  - is the manager for medical affairs; and is the senior director of medical affairs 
      at Metagenics, Inc, in Gig Harbor, Washington. is a director at Health Research 
      Services GmbH in Ubstadt-Weiher, Germany. is the qualified person for 
      pharmacovigilance (QPPV) at Dr. Loges + Co. GmbH in Winsen (Luhe), Germany. is a 
      director at Chemisch-Pharmazeutische Fabrik Goppingen, Carl Muller, Apotheker, 
      GmbH & Co KG, in Goppingen, Germany. is medical director and head of the 
      Department of Obstetrics and Gynecology Bruchsal, Teaching Hospital of the 
      University of Heidelberg in Heidelberg, Germany.
FAU - Wacker, Jurgen
AU  - Wacker J
AD  - is the manager for medical affairs; and is the senior director of medical affairs 
      at Metagenics, Inc, in Gig Harbor, Washington. is a director at Health Research 
      Services GmbH in Ubstadt-Weiher, Germany. is the qualified person for 
      pharmacovigilance (QPPV) at Dr. Loges + Co. GmbH in Winsen (Luhe), Germany. is a 
      director at Chemisch-Pharmazeutische Fabrik Goppingen, Carl Muller, Apotheker, 
      GmbH & Co KG, in Goppingen, Germany. is medical director and head of the 
      Department of Obstetrics and Gynecology Bruchsal, Teaching Hospital of the 
      University of Heidelberg in Heidelberg, Germany.
LA  - eng
PT  - Journal Article
PL  - United States
TA  - Integr Med (Encinitas)
JT  - Integrative medicine (Encinitas, Calif.)
JID - 101196303
PMC - PMC4982646
EDAT- 2016/08/23 06:00
MHDA- 2016/08/23 06:01
PMCR- 2017/06/01
CRDT- 2016/08/23 06:00
PHST- 2016/08/23 06:00 [entrez]
PHST- 2016/08/23 06:00 [pubmed]
PHST- 2016/08/23 06:01 [medline]
PHST- 2017/06/01 00:00 [pmc-release]
AID - 34-39 [pii]
PST - ppublish
SO  - Integr Med (Encinitas). 2016 Jun;15(3):34-9.