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MHRA herbal product warning

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People taking a herbal remedy commonly used to relieve symptoms of the menopause are at risk of developing liver problems, the Medicines and Healthcare products Regulatory Agency (MHRA) has warned.

Its reminder follows an incident of liver failure, which resulted in a liver transplant having to be carried out. The case is still being investigated but it is suspected to have been caused by a product containing Black Cohosh.

Products containing Black Cohosh - some authorised by the Traditional Herbal Registration (THR) scheme and others unlicensed but still legally on the market - can be bought in health food shops, pharmacies and supermarkets.

The MHRA’s medicines safety reporting system has taken 53 reports of adverse reactions thought to be linked to products containing Black Cohosh. Of them 36 cases - or well over two-thirds of the total - involved liver problems such as hepatitis, jaundice and abnormal liver function.

Manufacturers have been asked since 2006 to include appropriate warnings about possible liver problems on product labelling but the MHRA has recently found some unlicensed products — which do not carry the THR logo or registration number and have not had their quality assessed — could be on the market without them. It is reminding manufacturers that product labelling needs to include appropriate warnings.

The agency is recommending people only use registered herbal products bearing the THR logo and registration number on the packaging. Those products have been checked to make sure they are acceptably safe to use, with an accompanying leaflet detailing how it should be taken and possible side effects.

  • 3 Comments

Readers' comments (3)

  • All Herbal drugs should be NICE aproved in my opinion,

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  • The safest way to use herbal medicine is under the supervision of a qualified medical herbalist.

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  • bob cat

    Agree with statements above from posters. This article means very little without references to the cases involved. As I remember cases of liver problems occured in people with established liver problems and the dosages used were excessive. However some more accurate info would enable us all to decide what to think not just be told what to think.

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