Document Detail

United States Pharmacopeia review of the black cohosh case reports of hepatotoxicity.
MedLine Citation:
PMID:  18340277     Owner:  NLM     Status:  MEDLINE    
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.
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
Related Documents :
19630127 - The value of traditional reviews in the era of systematic reviewing.
20189157 - Reduced estrogen in menopause may predispose women to takotsubo cardiomyopathy.
19631507 - The prisma statement for reporting systematic reviews and meta-analyses of studies that...
20338117 - Endoscopic skull base/sinonasal adenocarcinoma surgery: what evidence exists?
19250287 - Neuropsychiatric side-effects of lidocaine: examples from the treatment of headache and...
5539727 - Perforated peptic ulcer in the vancouver area: a survey of 852 cases.
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    
USP Dietary Supplements Information Expert Committee (DSI EC), US Pharmacopeia, Rockville, MD, USA.
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms
Cimicifuga / adverse effects*
Dietary Supplements / adverse effects*
Drug Labeling
Liver / drug effects*
Phytotherapy / adverse effects*
Plant Preparations / adverse effects
Reg. No./Substance:
0/Plant Preparations
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

Previous Document:  Yield of the sural/radial ratio versus the medial plantar nerve in sensory neuropathies with a norma...
Next Document:  Transdermal estradiol reduces F2alpha-isoprostane levels in postmenopausal women.