Introduction
1. The issue
Black cohosh (Cimicifuga racemosa Nutt) is used traditionally as a herbal remedy for
rheumatism, rheumatoid arthritis, intercostal myalgia (pain in the rib muscles), sciatica (pain in
the lower back), whooping cough, chorea (loss of nervous-system function), tinnitus,
dysmenorrhoea (painful menstruation), and uterine colic (painful cramps of the muscle of the
uterus). At present, black cohosh is commonly used for treatment of symptom relief during
and after the menopause (eg, flushes and sweats, joint aches, and headaches). Estimates
suggest that in the UK 9 million treatment days for this product were purchased in 2004.
Published literature suggests that large doses of black cohosh might be associated with
gastrointestinal irritation, headache, dizziness, and vomiting. The long-term safety of black
cohosh is not known. Moreover, there has been a growing concern worldwide about the risk
of adverse effects on the liver (hepatotoxicity) associated with use of black cohosh.
This Public Assessment Report presents the evidence for an association between black
cohosh and adverse effects on the liver, which culminated in the recommendation by
independent experts (the Herbal Medicines Advisory Committee and the Commission on
Human Medicines) to add warnings about rare adverse liver reactions to the product
information for all black-cohosh products
2. Background
Black-cohosh products
At present, 27 products that contain black cohosh are licensed in the UK, including 11
homeopathic products. Of the 16 non-homeopathic products, only one product consists solely
of black cohosh; all other products are combinations of various herbal active ingredients.
Most non-homeopathic products are licensed for symptomatic relief of rheumatic pain; others
are used for various ailments such as cough, stomach cramps, menstrual pains and
bloatedness, and tenseness or irritability.
The number of unlicensed black-cohosh products that are marketed in the UK and their usage
is not known by the MHRA, who therefore approached the herbal sector in 2005. More than a
dozen companies provided useful information. There are a range of products available,
including combination products and single-herb products. These are available as tinctures (an
alcoholic extract), tablets, or capsules; some contain powdered root, others are extracts.
Calculation of the usage of black cohosh is difficult. According to information provided by the
herbal sector, however, for single-herb tablets and capsules at least 9 million treatment-days’
or 25 000 treatment-years’ worth of black cohosh were purchased in the UK in 2004. These
are only estimates, true usage may be higher.
Information provided by a few companies in the herbal sector suggests that the use of single-
constituent black-cohosh products has been rising steadily since the late 1990s, peaking in
2003. Although sales of this product are high, they seemed to decrease slightly in 2004, but
this may in part be due to incomplete information. Media coverage of potential side-effects
with herbal productsincluding black cohosh might have had a minor effect on sales.
Adverse effects on the liver
Concerns about adverse liver reactions suspected to be associated with the use of black
cohosh were first brought to the attention of the MHRA in 2002 through cases in the published
literature. In October 2003, media activity surrounded the publication of a case in the USA, in
which a woman developed liver failure and required a liver transplant after using a herbal
remedy that contained black cohosh.
In February 2004, this issue was discussed at the Committee on Safety of Medicines Sub
Committee on Pharmacovigilance (CSM SCOP, a panel of independent advisory experts). At
that time, the MHRA had received 4 UK spontaneous case reports of liver reactions
MHRA UKPAR – Black cohosh
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