Consumers are advised not to take unlicensed Butterbur (Peta

[herbsandhelpers]

Consumers are advised not to take unlicensed Butterbur (Petasites hybridus) herbal remedies

Advice to consumers - safe use of herbal medicines Traditional Herbal Medicines Registration Scheme

All herbal safety warnings and alerts - 27th January 2012

The MHRA has recently become aware that unlicensed herbal products containing Butterbur (Petasites hybridus) are being marketed in the UK and is warning consumers about the risks associated with the use of these products.   Butterbur contains pyrrolizidine alkaloids (PAs) which studies have shown can result in serious liver damage and organ failure. PAs have also been shown to lead to cancer in animals. Butterbur is most commonly used to treat migraine and hayfever.

Butterbur products have been associated with cases of liver toxicity; 40 cases have been reported in the literature. Of these cases, nine were of acute hepatitis and two of the nine cases resulted in liver failure requiring transplantation. The cases of liver toxicity appear to have occurred with extracts of Butterbur where the PAs had been removed and only small amounts remained. There is some evidence that other constituents found in Butterbur such as the sesquiterpene constituents for example petasin may be implicated in the liver toxicity. 

Due to the serious risks posed to individual patient’s health, the MHRA is advising anyone using products containing butterbur to stop doing so immediately and if they have any concerns they should seek the advice of their GP or pharmacist. Any suspected adverse reactions can be reported through the Yellow Card Scheme - www.mhra.gov.uk/yellowcard

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.

The MHRA advises any consumer wishing to take traditional herbal remedies to look for products with a traditional herbal registration.

Traditional herbal registration scheme - list of registered products

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 its quality can be assured and that is accompanied by the necessary information about how to use the product safely.

The MHRA has asked the herbal industry for their cooperation in voluntarily withdrawing herbal products containing Butterbur (petasitis hybridus) from the UK market.

Letter sent to herbal interest groups

The MHRA investigates 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.

More information on other products containing PAs can be found in the public consultation documentation on Senecio

Source: MHRA