FSC Black Cohosh product withdrawn from the market

All herbal safety warnings and alerts

9 December 2011

13 December 2011: It has been brought to our attention that Cambridge Commodities is not the manufacturer of the FSC Black Cohosh product recently withdrawn from the market and we apologise for any confusion caused.

In response to an urgent notice issued by the MHRA, Bee Health Ltd has agreed to stop marketing FSC Black Cohosh 1000 mg due to concerns about the high dosage of black cohosh in the product.

Some consumers may still have access to the product and other similar unlicensed black cohosh products and are warned to be vigilant. FSC products are wholesaled by Bee Health.

The MHRA advises consumers not to take the FSC Black Cohosh product as it equates to 50 times the dose approved for traditional herbal medicinal products used to relieve menopausal symptoms. It is not known what the risks or effects on the body could be associated with such a high level of Black Cohosh.

In addition, the product did not include the necessary safety warning about possible side affects from black cohosh that was agreed on a voluntary basis with the trade associations back in 2006. The agreed warning information is, “Black cohosh may rarely cause liver problems. If you become unwell (yellowing eyes/skin, nausea, vomiting, dark urine, abdominal pain, unusual tiredness) stop taking immediately and seek medical advice. Not suitable for patients with a previous history of liver disease”.

The MHRA advises any consumer wishing to take black cohosh to look for products with a traditional herbal registration. These can be identified by a THR number on their label.  A product with a THR has been assessed by the MHRA and so consumers can be confident that it is of a suitable strength for safe use and is accompanied by the necessary information about how to use the product safely.

Further information on safety can be found in the patient information leaflets included with the public assessment reports.

MHRA is currently investigating a number of complaints about herbal products being marketed without the necessary authorisation and will continue to take regulatory action to protect the public. In the meantime, should anyone have taken these products or have any concerns they should seek the advice of their GP. Please report any suspected adverse reactions through the Yellow Card Scheme - www..mhra.gov.uk/yellowcard

Page last modified: 13 December 2011