Posted 30 October 2012
The Medicines and Healthcare products Regulatory Agency (MHRA) is today reminding people about the risk of liver problems with the herbal remedy Black Cohosh – a product commonly used to relieve menopausal symptoms.
The reminder follows a serious case of liver failure resulting in a liver transplant suspected to have been caused by a herbal product containing Black Cohosh. The investigation of this case and of the product involved is ongoing.
To date, the MHRA has received 53 reports of adverse reactions suspected to be associated with the use of Black Cohosh products through its medicines safety monitoring reporting system, the Yellow Card Scheme. The majority of these reports (36) have involved liver problems including abnormal liver function, jaundice and hepatitis.
Black Cohosh products are available for general sale in pharmacies, supermarkets and health food shops. Currently, there are both authorised (registered under the Traditional Herbal Registration (THR) scheme) and unlicensed products legally on the market.
Since 2006, the MHRA has asked all manufacturers of Black Cohosh products to ensure that an appropriate warning about possible liver problems is included on the label. The MHRA recently became aware that some unlicensed products containing Black Cohosh may not have this warning and we are issuing a reminder to the sector of the need to carry appropriate warnings on their product labelling.
The MHRA always recommends that registered herbal products are used. Registered products can be identified by the Traditional Herbal Registration (THR) registration number or logo on their packaging. These products have been assessed and quality checked to ensure that they are acceptably safe to use and are accompanied by a leaflet with information on how to use the product with possible side effects listed.
The unlicensed products do not have the THR registration or logo number and have not been assessed for quality.
Richard Woodfield, the MHRA’s Head of Herbal Policy, said: “It is important that people with a history of liver problems do not use Black Cohosh herbal products
“Other people who wish to use Black Cohosh herbal products should check for the traditional herbal registration (THR) number on the packaging indicating that it has been made to assured standards. If the product does not have a THR registration number there would have been no assessment as to the safety or quality of the product.
“Reading the patient information leaflet ensures that you are aware of the correct way to take a medicine, the potential side effects as well as any possible interactions with other medication you may be taking. Unlicensed herbal products may have incomplete, inaccurate or no safety information and can mean you are gambling with your health, especially if you take these products without consulting a GP or qualified healthcare professional.”
Notes to Editor
1. Standards of safety and manufacture vary widely in the unlicensed herbal sector and the MHRA has issued a number of warnings about unlicensed herbal medicines and Traditional Chinese medicines. Under the UK traditional herbal registration scheme, introduced in 2005, manufactured over the counter traditional herbal medicines are required to meet standards of safety, quality and patient information.
2. The MHRA issued a safety warning about this product on 9 December 2011.
FSC Black Cohosh product withdrawn from the market
3. The MHRA have also issued previous press releases on issues relating to Black Cohosh.
Press release: UK regulator warns of the importance of using registered herbal medicines after discovering super-strength menopause remedy
Press release: MHRA action on safety concerns over black cohosh and liver injury
4. Herbal remedies should be used with the same caution and care as any other medicine as their use will have an effect on the body. While many herbal remedies are reasonably safe, it is important to remember that just because it contains natural ingredients and extracts this doesn’t guarantee it is safe. People should always consult with a pharmacist or doctor to make sure that a herbal remedy is suitable for them to take and will not interact with any other medicines they may be taking. Stay safe when using herbal remedies, follow us on Twitter @staysafeherbals
5. The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks. We keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem. We encourage everyone – the public and healthcare professionals as well as the industry – to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action.
Date: 29 October 2012
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