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

Mahady, Gail B. PhD1; Dog, Tieraona Low MD1,2; Barrett, Marilyn L. PhD1; Chavez, Mary L. PharmD1; Gardiner, Paula MD1; Ko, Richard PharmD, PhD1; Marles, Robin J. PhD1; Pellicore, Linda S. PhD*1; Giancaspro, Gabriel I. PhD3; Sarma, Dandapantula N. PhD3

Menopause:
doi: 10.1097/gme.0b013e31816054bf
Articles
Abstract

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.

In Brief

The article presents the US Pharmacopeia Dietary Supplements Information Expert Committee safety review of black cohosh. The committee proposed a cautionary label statement for US Pharmacopeia black cohosh dietary supplement monographs.

Author Information

From the 1USP Dietary Supplements Information Expert Committee (DSI EC), US Pharmacopeia, 2Chair, DSI EC, and 3US Pharmacopeia, Rockville, MD.

Received August 29, 2007; revised and accepted October 29, 2007.

Financial disclosure: None reported.

*Disclaimer: The opinions and/or conclusions expressed are solely those of the authors and in no way imply a policy or position of the FDA.

Address correspondence to: Dandapantula N. Sarma, PhD, 12601 Twinbrook Parkway, Rockville, MD 20852; E-mail: dns@usp.org

©2008The North American Menopause Society