HC Deb 26 February 2003 vol 400 cc623-5W
Tim Loughton

To ask the Secretary of State for Health (1) what criteria the Medicines Control Agency set for the Committee on Safety of Medicines and the Medicines Commission in their investigation into kava-kava; 96047]

(2) in what form the conclusions of the Committee on Safety of Medicines and the Medicines Commission into the safety of kava-kava were presented. [96048]

Ms Blears

The Medicines Control Agency (MCA) consulted the Committee on Safety of Medicines (CSM) on the safety of kava-kava, as this falls within its statutory terms of reference which are: "to give advice with respect to safety, quality and efficacy in relation to human use of any substance or article (not being an instrument, apparatus or appliance) to which any provision of the Medicines Act 1968 is applicable; to promote the collection and investigation of information relating to adverse reactions for the purpose of enabling such advice to be given."

The CSM convened an expert working group with the following remit. To consider the currently available evidence on the issue of hepatotoxicity suspected to be associated with the use of the herbal remedy kava-kava (piper methysticum). To assess the risks to public health and whether these can be quantified or prevented and to advise on the risk/benefit balance. To consider the possible regulatory actions and provide advice on a recommended course of action including how the information should be distributed to healthcare professionals and consumers.

The CSM received the working group's recommendations, considered the available evidence and arguments and gave preliminary advice that the most appropriate regulatory option was the revocation of the marketing authorisations for the three licensed products containing kava-kava and prohibition of the supply of the unlicensed products under section 62 of the Medicines Act. Other options considered were label warnings about hepatic adverse reactions; restrictions of strength, dosage or type of formulation; restricting the status of kava-kava to a prescription only medicine or no regulatory action.

Following preliminary advice from CSM the MCA undertook a public consultation on the prohibition of kava-kava. The MCA sought advice on the responses to the consultation both from the CSM and the Medicines Commission, whose terms of reference are broadly to advise Health Ministers on matters relating to the execution of the Medicines Act 1968. Both bodies were asked to advise on the regulatory options in light of the latest scientific evidence and the responses to public consultation. Both advised that kava-kava should be prohibited in unlicensed medicines and that the marketing authorisations for the licensed products should be revoked.

The advice of the CSM and Medicines Commission on the safety of kava-kava is contained within the minutes of the meetings, which are available in the Library, together with copies of the assessment reports.

In the light of this advice and having considered all the evidence the Minister considered that the sale, supply and importation of kava-kava should be prohibited.

Tim Loughton

To ask the Secretary of State for Health (1) what case reports of liver damage suspected to be associated with the consumption of Kava-Kava he has received from countries other than Switzerland, Germany, Australia, Canada, France, USA and the UK; and whether evidence of such cases was sought; [96502]

(2) if he will list member states of the EEA in which products containing Kava-Kava are not prohibited; [96501]

(3) when the 70 case reports of liver damage suspected to be associated with the consumption of Kava-Kava received by the MCA occurred; and of the 70 cases, how many included a biopsy taken from the patient's liver. [96503]

Ms Blears

The regulatory position of kava-kava in Europe has continually changed over the last 12 months as member states completed their regulatory action. The Medicines Control Agency (MCA) has requested this information from all European Economic Area member states. A report has been placed in the Library. It is known that when the various national expert committees considered this issue, kava-kava has been prohibited, suspended or had never been marketed in the following member states: Denmark, Finland, France, Ireland, Italy, Germany, Greece, Netherlands, Portugal, Spain and Sweden.

The MCA has received no case reports of hepatotoxicity associated with kava-kava from countries other than the United Kingdom, Germany, Switzerland, France, Australia, Canada and the USA. The MCA has requested this information from all EEA member states as well as Australia, Canada and the USA.

The following table provides a breakdown of the number of cases of suspected liver damage associated with kava-kava submitted to regulatory authorities with information relating to the onset date of the hepatic reactions. Information relating to the date of onset of the hepatic adverse reactions suspected to be associated with the use of kava-kava has not been provided in 20 of the 70 cases. Three of the case reports state that a liver biopsy was completed.

Year reaction occurred Number of cases of hepatotoxicity
1990 1
1991 0
1992 1
1993 1
1994 2
1995 1
1996 0
1997 1
1998 4
1999 4
2000 8
2001 23
2002 4

A report of a suspected adverse reaction does not necessarily mean that it was caused by the medicine and the number of reports received cannot be used as a basis for determining the incidence of a reaction, as neither the total number of reactions occurring nor the number of patients using the herbal medicine is known.

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