Response to Teschke et al.

Pharmacoepidemiology and Drug Safety

Volumn 21, Issue 3, 2012, Pages 339-340

  Mahady, Gail ^a   Dog, Tieraona Low ^b   Sarma, Nandakumara D ^c   Griffiths, James ^c   Giancaspro, Gabriel I ^c  

^a UNIVERSITY OF ILLINOIS AT CHICAGO   (United States)

^b UNIVERSITY OF ARIZONA   (United States)

^c UNITED STATES PHARMACOPEIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CIMICIFUGA RACEMOSA; CONSUMER ADVOCACY; DATA ANALYSIS; DRUG SAFETY; HUMAN; LETTER; LIVER TOXICITY; MEDICAL SOCIETY; PHARMACOEPIDEMIOLOGY; PRIORITY JOURNAL; PRODUCT SAFETY; RATING SCALE; SCORING SYSTEM;

ADVERSE DRUG REACTION REPORTING SYSTEMS; CIMICIFUGA; DRUG-INDUCED LIVER INJURY; FEMALE; HUMANS; PLANT EXTRACTS;

EID: 84858196349     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.3210     Document Type: Letter

References (9)

1. Teschke R, Schmidt-Taenzer W, Wolff A. Spontaneous reports of assumed herbal hepatotoxicity by black cohosh: is the liver-unspecific Naranjo scale precise enough to ascertain causality? Pharmacoepidemiol Drug Saf 2011; 20: 567-582.
2. European Medicines Agency. Draft assessment report on Cimicifuga racemosa (L.) Nutt., rhizome. Doc. Ref.: EMEA/HMPC/3968/2008. September 2009. (accessed August 11, 2011).
3. Teschke R. Black cohosh and suspected hepatotoxicity: inconsistencies, confounding variables, and prospective use of a diagnostic causality algorithm. A critical review. Menopause 2010; 17: 426-440.
4. Mahady G, Low Dog T, Sarma DN, Giancaspro GI. Suspected black cohosh hepatotoxicity-causality assessment versus safety signal. Maturitas 2009; 64: 139-140; author reply 141-2. Comment on Maturitas. 2009; 63: 302-314.
5. Rochon J, Protiva P, Seeff LB, Fontana RJ, Liangpunsakul S, Watkins PB, et al. Reliability of the Roussel Uclaf Causality Assessment Method for assessing causality in drug-induced liver injury. Hepatology 2008; 48: 1175-1183.
6. Mahady GB, Low Dog T, Barrett ML, et al. United States Pharmacopeia review of the black cohosh case reports of hepatotoxicity. Menopause 2008; 15: 628-638.
7. MHRA action on safety concerns over black cohosh and liver injury. 2006. Available at: (accessed August 11, 2011).
8. Australian Therapeutic Goods Administration Statement. New labeling and consumer information for medicines containing black cohosh (Cimicifuga racemosa). 2007. Available at: (accessed August 11, 2011).
9. Mahady G, Low Dog T, Sarma DN, et al. Suspected black cohosh hepatotoxicity-causality assessment versus safety signal. Maturitas 2009; 64: 139-140.