Medicines and Healthcare Products Regulatory Agency

 MHRA Press Release,  Jul 21, 2006

Black cohosh (Cimicifuga racemosa) - risk of liver problems

July 2006

Traditionally, black cohosh (Cimicifuga racemosa) has been used to treat a variety of conditions including rheumatism, rheumatoid arthritis, joint aches, muscle pain and neuralgia. Now it is most commonly used to treat menopausal symptoms such as hot flushes, night sweats, joint aches, headaches, insomnia, palpitations.

As of 31 May 2006, 31 reports of suspected adverse reactions associated with black cohosh have been received through the Yellow Card Scheme. Of these, 22 have been reports of liver reactions - ranging in severity from abnormal liver function (15 people) to various forms of hepatitis (six people) including one case of liver failure. Generally, the individuals recovered or were recovering after stopping black cohosh.

Original concerns about potential risks associated with the use of  black cohosh were raised in 2004 when a number of reports of hepatotoxicity (liver disease) were reported and MHRA issued an alert to health professionals.

Following further reports of suspected adverse reactions, the Commission on Human Medicines and the Herbal Medicines Advisory Committee reviewed the available data on liver reactions with black cohosh and, subsequently, advised that these data support a causal association between black cohosh and the risk of liver disorders.

Warnings are being added to the labels for all black cohosh products and the MHRA is working with the relevant marketing authorisation holders and the herbal sector to ensure people are fully informed about this potential risk.
 
There are many signs and symptoms of liver disease. These include jaundice (yellowing of the skin or whites of the eyes), dark urine, nausea, vomiting, unusual tiredness, weakness, stomach or abdominal pain, and /or loss of appetite. If you think you are experiencing any of these symptoms you should stop taking black cohosh immediately and seek medical advice.

Anyone who has previously experienced any liver complaint or any other serious health complaint is advised not to take black cohosh without speaking to their doctor first.  It is important to discuss all of the medication you are taking, including herbal products, with your doctor or herbal practitioner to ensure you receive the appropriate care.

Further information is available in the following questions and answers document:
› Black cohosh and liver injury: Questions and Answers  [ PDF format ].

The European Medicines Agency (EMEA) has issued the following statement:
› Public Statement on Herbal Medicinal Products containing Cimicifugae Racemosae Rhizoma (Black Cohosh, Root)  [ PDF format ].