Document Detail


United States Pharmacopeia review of the black cohosh case reports of hepatotoxicity.
MedLine Citation:
PMID:  18340277     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: Black cohosh [Actaea racemosa L., formerly Cimicifuga racemosa (L.) Nutt.] is a botanical used mainly for the management of menopausal symptoms. Recently, regulatory agencies in Australia, Canada, and the European Union have released statements regarding the "potential association" between black cohosh and hepatotoxicity. In response, the Dietary Supplement Information Expert Committee of the US Pharmacopeia's Council of Experts reviewed safety information for black cohosh products. DESIGN: The Expert Committee analyzed information from human clinical case reports, adverse event reports, animal pharmacological and toxicological data, historical use, regulatory status, and contemporaneous extent of use. Reports were obtained from diverse sources, including the European Medicines Agency, Health Canada, the Australian Therapeutic Goods Administration, and the US Food and Drug Administration. Case reports pertaining to liver damage were evaluated according to the Naranjo causality algorithm scale. RESULTS: Thirty nonduplicate reports on use of black cohosh products concerning liver damage were analyzed. All the reports of liver damage were assigned possible causality, and none were probable or certain causality. The clinical pharmacokinetic and animal toxicological information did not reveal unfavorable information about black cohosh. CONCLUSIONS: Based on this safety review, the Dietary Supplement Information Expert Committee determined that black cohosh products should be labeled to include a cautionary statement. This is a change from the Expert Committee's decision of 2002, which required no such statement. With this decision, the US Pharmacopeia's Botanical Expert Committee may develop monographs for black cohosh, and the US Pharmacopeia may offer its verification programs to dietary supplement ingredient and product manufacturers.
Authors:
Gail B Mahady; Tieraona Low Dog; Marilyn L Barrett; Mary L Chavez; Paula Gardiner; Richard Ko; Robin J Marles; Linda S Pellicore; Gabriel I Giancaspro; Dandapantula N Sarma
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Publication Detail:
Type:  Journal Article; Review    
Journal Detail:
Title:  Menopause (New York, N.Y.)     Volume:  15     ISSN:  1072-3714     ISO Abbreviation:  Menopause     Publication Date:    2008 Jul-Aug
Date Detail:
Created Date:  2008-08-13     Completed Date:  2008-09-12     Revised Date:  2009-04-09    
Medline Journal Info:
Nlm Unique ID:  9433353     Medline TA:  Menopause     Country:  United States    
Other Details:
Languages:  eng     Pagination:  628-38     Citation Subset:  IM    
Affiliation:
USP Dietary Supplements Information Expert Committee (DSI EC), US Pharmacopeia, Rockville, MD, USA.
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MeSH Terms
Descriptor/Qualifier:
Cimicifuga / adverse effects*
Dietary Supplements / adverse effects*
Drug Labeling
Female
Humans
Liver / drug effects*
Phytotherapy / adverse effects*
Plant Preparations / adverse effects
Chemical
Reg. No./Substance:
0/Plant Preparations
Comments/Corrections
Comment In:
Menopause. 2008 Jul-Aug;15(4 Pt 1):583   [PMID:  18475214 ]
Menopause. 2009 Jan-Feb;16(1):215-6; author reply 216   [PMID:  19131848 ]
Menopause. 2009 Jan-Feb;16(1):214; author reply 214-5   [PMID:  19131847 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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