The Medicines Control Agency (MCA) and Committee on Safety of Medicines (CSM) have welcomed as responsible the decision by a number of organisations representing manufacturers, retailers and herbal practitioners to ask their members to withdraw from sale temporarily any remedies containing the herbal ingredient Kava-kava. This voluntary move is a precautionary measure in the light of serious liver side effects reported in Germany and Switzerland. No such adverse effects have been seen in the UK.

The MCA is currently assessing the emerging evidence on Kava-kava and its effects on the liver. In the meantime, in view of potential concerns over safety it would be prudent for the public to stop taking any product or remedy containing Kava-kava. There should not be any adverse effects from stopping the medication abruptly. Anyone concerned about their health should talk to their doctor or pharmacist.

Kava-kava may also be used as an ingredient in certain food products. In the light of these reports the Food Standards Agency (FSA) is advising consumers to avoid these products as a precautionary measure, until further information on safety is available. The FSA has said that it too would support similar voluntary action by industry on products containing Kava-kava that are sold under food law.

NOTES FOR EDITORS

1. Kava-kava (Piper methysticum) is used extensively in Europe as a traditional herbal remedy for the treatment of anxiety and in the UK also for ailments affecting the bladder and digestive tracts. In the UK Kava-kava is widely available over the counter. Although three products are licensed, the majority of Kava-kava containing products are unlicensed and available over the counter under the section 12 exemption of the 1968 Medicines Act. Some products are also sold as food.

2. The Medicines Control Agency (MCA) and Committee on Safety of Medicine (CSM) monitor the safety of all herbal medicines including unlicensed herbal remedies used in the UK using the same methods as used for conventional medicines. This includes the assessment of all reports of suspected adverse reactions received through the Yellow Card Scheme, which was extended to include unlicensed herbal remedies in October 1996.

3. The 30 cases of hepatotoxicity reported from Germany and Switzerland varied in severity from abnormal liver function to liver failure. There were 6 cases of liver failure, one of which was fatal and 4 required liver transplants; the 6th case was being evaluated for a transplant at the time of reporting. Onset of the reactions varied from 2 weeks to 2 years. In a number of these cases, however, the evidence was complicated by other factors such as concomitant drugs which themselves have previously been linked with liver problems.

4. Regulatory authorities in Germany and elsewhere in the European Union are reviewing the evidence before deciding what regulatory action may be appropriate. The MCA is closely monitoring the emerging safety issue and has also invited the herbal sector to provide any information it holds on the issue. In the light of this further information the Agency will seek further expert independent advice from the CSM and will then come forward with further advice or regulatory proposals as may be appropriate.

5. Several major suppliers have already temporarily withdrawn their stocks of Kava-kava products. A number of trade associations and representatives of herbalists and pharmacists have either already advised their members to take similar action or have said that they intend to do so.

6. The FSA has issued a food hazard warning (FHW) to local enforcement officers to advise them of the current precautionary action. The FHW can also be obtained from the Agency's website at www.food.gov.uk.

The Medicines Control Agency (MCA) and Committee on Safety of Medicines (CSM) have welcomed as responsible the decision by a number of organisations representing manufacturers, retailers and herbal practitioners to ask their members to withdraw from sale temporarily any remedies containing the herbal ingredient Kava-kava. This voluntary move is a precautionary measure in the light of serious liver side effects reported in Germany and Switzerland. No such adverse effects have been seen in the UK.

The MCA is currently assessing the emerging evidence on Kava-kava and its effects on the liver. In the meantime, in view of potential concerns over safety it would be prudent for the public to stop taking any product or remedy containing Kava-kava. There should not be any adverse effects from stopping the medication abruptly. Anyone concerned about their health should talk to their doctor or pharmacist.

Kava-kava may also be used as an ingredient in certain food products. In the light of these reports the Food Standards Agency (FSA) is advising consumers to avoid these products as a precautionary measure, until further information on safety is available. The FSA has said that it too would support similar voluntary action by industry on products containing Kava-kava that are sold under food law.

NOTES FOR EDITORS

1. Kava-kava (Piper methysticum) is used extensively in Europe as a traditional herbal remedy for the treatment of anxiety and in the UK also for ailments affecting the bladder and digestive tracts. In the UK Kava-kava is widely available over the counter. Although three products are licensed, the majority of Kava-kava containing products are unlicensed and available over the counter under the section 12 exemption of the 1968 Medicines Act. Some products are also sold as food.

2. The Medicines Control Agency (MCA) and Committee on Safety of Medicine (CSM) monitor the safety of all herbal medicines including unlicensed herbal remedies used in the UK using the same methods as used for conventional medicines. This includes the assessment of all reports of suspected adverse reactions received through the Yellow Card Scheme, which was extended to include unlicensed herbal remedies in October 1996.

3. The 30 cases of hepatotoxicity reported from Germany and Switzerland varied in severity from abnormal liver function to liver failure. There were 6 cases of liver failure, one of which was fatal and 4 required liver transplants; the 6th case was being evaluated for a transplant at the time of reporting. Onset of the reactions varied from 2 weeks to 2 years. In a number of these cases, however, the evidence was complicated by other factors such as concomitant drugs which themselves have previously been linked with liver problems.

4. Regulatory authorities in Germany and elsewhere in the European Union are reviewing the evidence before deciding what regulatory action may be appropriate. The MCA is closely monitoring the emerging safety issue and has also invited the herbal sector to provide any information it holds on the issue. In the light of this further information the Agency will seek further expert independent advice from the CSM and will then come forward with further advice or regulatory proposals as may be appropriate.

5. Several major suppliers have already temporarily withdrawn their stocks of Kava-kava products. A number of trade associations and representatives of herbalists and pharmacists have either already advised their members to take similar action or have said that they intend to do so.

6. The FSA has issued a food hazard warning (FHW) to local enforcement officers to advise them of the current precautionary action. The FHW can also be obtained from the Agency's website at www.food.gov.uk.