Unlicensed herbal remedy could cause liver and organ damage

People taking an unlicensed herbal product that could cause serious liver damage and organ failure should stop using it, says the UKs Medicines and Healthcare products Regulatory Agency (MHRA).


The medicines regulator is aware that herbal products containing butterbur (Petasites hybridus) are being marketed in the UK and has issued a letter to the UK herbal industry asking them to remove these products from sale.

Butterbur is most commonly used to treat migraine and hayfever and contains pyrrolizidine alkaloids (PAs) which studies have shown can result in serious liver damage and organ failure.

There are no products containing butterbur licensed for use in the UK under the Traditional Herbal Registration scheme and the sale of butterbur is prohibited or restricted in a number of other European countries. There have been no adverse drug reactions reported in the UK but cases of liver toxicity have been linked with these products in Europe.

Head of Herbal Policy, Richard Woodfield, said "We advise anyone taking these products to stop doing so. If you have any concerns, speak to your GP or pharmacist. If you think you have suffered a side effect from these products, tell us through our reporting system called the Yellow Card Scheme.

When looking for herbal medicines, you should look for herbal products that have a traditional herbal registration or a product licence, so that you can be confident the product has been assessed as meeting appropriate safety standards, and has the necessary patient information. Some unlicensed herbal medicines can pose a serious risk to your health.

We will continue to take regulatory action against herbal medicines not marketed within the Traditional Herbal Registration Scheme.

Products with a traditional herbal registration can be identified by a THR number on their label. A product with a THR has been assessed by the MHRA so that consumers can be confident that its quality can be assured and that is accompanied by the necessary information about how to use the product safely.

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