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Black cohosh (Cimicifuga racemosa)

New labelling requirements and consumer information for medicines containing Black cohosh

29 May 2007

Summary

  • Medicines containing the herb Black cohosh are currently required to have a label statement advising of the possible risk of liver damage.
  • Following recent reports in Australia of liver damage in patients also taking Black cohosh, the Therapeutic Goods Administration established an expert advisory group to review the existing regulatory controls on Black cohosh.
  • The expert group concluded that there appears to be an association between the use of Black cohosh and liver damage, but that it is very rare.
  • The expert group also determined that Black cohosh is still suitable for use in complementary medicines, but recommended that the current warning statement on the medicine label be revised to better inform consumers about the risk and also to provide sufficient information to assist in the early detection of liver damage and, if detected, to seek medical attention.

Background

Black cohosh (Cimicifuga racemosa) is a herb that has a long history of traditional use in North American Indian medicine and has been used widely in Western cultures since the early 1800s. It is generally used for the relief of the symptoms of menopause and is approved for use in Australia in medicines sold in pharmacies, supermarkets and other retail outlets.

The Therapeutic Goods Administration (TGA) reviewed the safety of Black cohosh in 2005 following reports of possible liver problems internationally and in Australia.

At the time of the review, there were 47 cases of liver reactions worldwide, including 9 Australian cases. In Australia, four patients were hospitalised, including two who required liver transplantation. Although some reports are confounded by multiple ingredients, by more than one medication or by other medical conditions, there is sufficient evidence of a causal association between Black cohosh and serious hepatitis.

Considering the widespread use of Black cohosh, the incidence of liver reaction appears to be very low. Following the safety review, the TGA decided that medicines containing Black cohosh must carry the following label statement:

"Warning: Black cohosh may harm the liver in some individuals. Use under the supervision of a healthcare professional".

Expert Advisory Group

Since the initial safety review, some additional cases of liver reactions in association with the use of medicines containing Black cohosh have been reported in Australia. In order to determine whether additional regulatory controls for Black cohosh medicines might be necessary, the TGA convened a group of experts from Australia and New Zealand to provide advice on this matter.

The expert advisory group examined a total of 16 Australian reports of suspected liver damage and 11 were judged at least possibly related to black cohosh use, including 3 cases of liver transplantation. Following consideration of all available information, the group concluded that there appears to be an association between the use of Black cohosh and liver damage, but that it is very rare. It was not possible to identify, with any certainty, the strength of the association, or any particular vulnerable group, type of preparation, dose, duration of use or specific products.

New label requirement

The expert advisory group considered that Black cohosh is still suitable for use in complementary medicines, but recommended a revised warning statement on the medicine label. The revised warning should aim to ensure that consumers are appropriately informed about the risk, provide sufficient information to assist them in the early detection of the more critical signs and symptoms of liver reactions and, if detected, to seek medical attention (see Symptoms of liver disease below).

The TGA is currently consulting on the wording for the new warning statement for Black cohosh-containing medicines.

Consumers and healthcare practitioners

It is important that consumers tell their doctor, pharmacist or other healthcare professional about all the medicines they are taking, including herbal or other complementary medicines.

The TGA is raising awareness among healthcare practitioners of the association between Black cohosh and liver reactions and advising them to be on the lookout for signs of liver toxicity associated with the use of Black cohosh medicines.

Symptoms of liver disease

There can be many causes of liver damage, including medicines. Some medicines produce damage only rarely in susceptible individuals; the injury is generally unpredictable and may be reversible. Symptoms of liver disease can include jaundice (yellowing of the skin or whites of the eyes), dark urine, nausea, vomiting, diarrhoea, weight loss, unusual tiredness, appetite loss, fever, bloated abdomen or abdominal pain.

Consumers who experience any of these symptoms while taking, or after using, a Black cohosh product should seek medical advice. Consumers who have previously experienced any liver complaints should not take Black cohosh without consulting their doctor first.

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Content last updated: Tuesday, 29 May 2007

Web page last updated: Monday, 21 February 2011

URL: http://www.tga.gov.au/safety/alerts-medicine-black-cohosh-070529.htm