United States Pharmacopeia review of the black cohosh case reports of hepatotoxicity.
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.


METHODS
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.
Mahady
Gail B
GB
USP Dietary Supplements Information Expert Committee (DSI EC), US Pharmacopeia, Rockville, MD, USA.
Low Dog
Tieraona
T
Barrett
Marilyn L
ML
Chavez
Mary L
ML
Gardiner
Paula
P
Ko
Richard
R
Marles
Robin J
RJ
Pellicore
Linda S
LS
Giancaspro
Gabriel I
GI
Sarma
Dandapantula N
DN
D031885:Cimicifuga / Q000009:adverse effects*; D019587:Dietary Supplements / Q000009:adverse effects*; D004348:Drug Labeling; D005260:Female; D006801:Humans; D008099:Liver / Q000187:drug effects*; D008517:Phytotherapy / Q000009:adverse effects*; D028321:Plant Preparations / Q000009:adverse effects
D028321:Plant Preparations