Kava--the unfolding story: report on a work-in-progress.
This paper, originated as a submission (now updated) to the U.K. Medicines Control Agency and Committee of Safety of Medicines (CSM) on January 11, 2002, in response to a report circulated by the German Federal Institute for Drugs and Medical Products (German initials are BfArM), a compilation of which is summarized in Appendix 2. This agency issued notification in late November 2001 of some thirty adverse events associated with the use of concentrated standardized preparations of kava (Piper methysticum, Forst. f.) reported from Germany and Switzerland. An analysis of the summary of the BfArM case reports (see Appendix 2) shows that these contain duplications among the cases cited. The original submission that was sent to the CSM January 2002 has been updated to the version published here. This new version was completed in April 2002. As a result of the alert from BfArM, the evaluation of kava's safety is now occurring on a worldwide basis and, being that this a matter of considerable importance to the public, the health care community, and regulatory authorities as well as to kava farmers throughout Polynesia, it is it important to depict this progress report. As such, this updated report does not provide final answers. The material released by the BfArM is lacking in detail; however, it is hoped that this report will shed light on the kava controversy. It is anticipated that there will be further updates shortly. This report, prepared on behalf of the Traditional Medicines Evaluation Committee, a subcommittee of the European Herbal Practitioners Association, argues that many of the adverse events cited by the BfArM should not be attributed to kava. In addition, the report states that the properties of concentrated standardized kava extracts - as opposed to preparations that closely approximate those created for traditional use - contribute to causing adverse events. This report proposes a number of simple measures that will ensure that safe kava preparations may continue to be available in the United Kingdom.
Denham
Alison
A
University of Central Lancashire, Preston, United Kingdom. adenham@uclan.ac.uk
McIntyre
Michael
M
Whitehouse
Julie
J
D016907:Adverse Drug Reaction Reporting Systems; D014151:Anti-Anxiety Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000737:chemistry / Q000493:pharmacokinetics*; D019389:Cytochrome P-450 CYP2D6 / Q000172:deficiency / Q000378:metabolism; D003577:Cytochrome P-450 Enzyme System / Q000378:metabolism*; D004305:Dose-Response Relationship, Drug; D017277:Drug Approval; D004339:Drug Compounding; D014943:Global Health; D006801:Humans; D007391:International Cooperation; D020901:Kava / Q000009:adverse effects; D010936:Plant Extracts / Q000008:administration & dosage / Q000009:adverse effects* / Q000737:chemistry / Q000493:pharmacokinetics*; D006113:United Kingdom
D014151:Anti-Anxiety Agents; D010936:Plant Extracts; D003577:Cytochrome P-450 Enzyme System; D019389:Cytochrome P-450 CYP2D6