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Listen to this siteFriday 21 December 2001
CATEGORY D : 'FOR INFORMATION ONLY'
Ref: 53/2001
The FSA has been advised of concerns raised by the German Medicines Regulatory Authorities concerning the safety of the herbal agent kava kava after 30 reports of serious liver damage in Germany and Switzerland. These reports involve a range of products contaning kava kava or one of its ingredients (kavain). In the light of these reports, the FSA and the Medicines Control Agency (MCA) are advising consumers not to use these products as a precautionary measure, until further information on safety is available.
Kava kava ( Piper methysticum ) is used extensively in Europe as a traditional herbal remedy for the treatment of anxiety. Whilst most products available in the UK are medicines or herbal remedies there are also some foods and food supplements based on this ingredient.
The UK Committee on Safety of Medicines (CSM) considered the issue last week and indicated that it had significant concerns about the safety of kava kava.
Several major European companies, including UK manufacturers and distributors of licensed products containing kava kava, have voluntarily removed their products from the market pending a full review of the safety of such preparations by regulatory authorities.
The issue is still under consideration in Germany and there are some uncertainties about aspects of the reported cases and further information is expected.
The Medicines Control Agency is urging withdrawal of affected products as a precautionary measure and considering the need for regulatory action.
In addition, the Medicines Control Agency has written to all herbal interest groups (including the retail sector, manufacturing and herbals practitioners) requesting that they voluntarily withdraw kava kava products as a precautionary measure.
The FSA is supporting this action regarding kava kava products that are sold under food law
This information is intended to inform local authorities of these developments and to assist in dealing with any enquiries that they may receive from consumers. The Food Standards Agency will update food authorities as and when further information becomes available.
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