Proceedings of the Tenth International Conference of Drug Regulatory Authorities (ICDRA) - Hong Kong, China, 24 - 27 June 2002
(2002; 166 pages) View the PDF document
Table of Contents
View the documentAbbreviations and acronyms used in this report
Open this folder and view contentsOpening ceremony
Open this folder and view contentsHerbal medicines
Open this folder and view contentsKeynote address
Open this folder and view contentsSafety of blood-derived products
Open this folder and view contentsAntimicrobial resistance - new initiatives
Open this folder and view contentsHarmonization I
Open this folder and view contentsHarmonization II
Open this folder and view contentsProtection of trial subjects in clinical trials
Open this folder and view contentsRegulating biotechnology products
Open this folder and view contentsRegulatory challenges: health sector reform and drug regulatory capacity
Open this folder and view contentsAccess to drugs and vaccines I
Open this folder and view contentsAccess to drugs and vaccines II
Open this folder and view contentsCounterfeit pharmaceutical products
Open this folder and view contentsHomoeopathy
Open this folder and view contentsSafety monitoring
Open this folder and view contentsE-Commerce
Close this folderCurrent topics
View the document“For export only” manufactured drugs and cosmetics that are not legally used in country of manufacture
View the documentWHO Certification Scheme: input for implementation
View the documentValue of joining the Pharmaceutical Inspection Cooperation Scheme (PIC/S) for developing countries: the Malaysian experience
View the documentPharmacopoeial specifications for new drug entities
View the documentImproving the impact of drug regulatory authorities on public health
View the documentStrengthening drug regulatory authorities in small Pacific Island nations
View the documentTransparency of data
View the documentKava
View the documentXenotransplantation and xenotourism: time for concerted regulatory action
View the documentRecommendations
Open this folder and view contentsRegulatory challenges of new technologies
View the documentList of participants
View the documentBack cover
 

Kava

Dr Rolf Spang, Switzerland

Four cases of severe hepatic complications associated with a kava root acetone extract occurred within a period of 7 months in Switzerland up to spring 2000. The incidence of severe hepatic complications can be estimated at around 1 in 35 000 patient-months in Switzerland and 1 in 175 000 patient-months globally.

Taking into account the benefits and available alternatives, the registration of the kava root acetone extract in Switzerland was provisionally suspended in September 2000 and definitely withdrawn in April 2001. The alcohol extract and a synthetic preparation containing 1-kavaine, with a seemingly lower incidence of severe liver reactions, have remained on the market, but were moved in autumn 2001 to “pharmacy only” status with a strong warning on the risk of liver injury and possible early symptoms.

While Switzerland is still receiving reports of severe liver reactions associated with the acetone extract, one recent case of hepatocellular injury has been attributed to a combination of the synthetic kavapyrone 1-kavaine combined with magnesium orotate and vitis viniferae extractum. In the meantime, several reports of severe hepatitis or liver injury associated with ethanol kava extract have been notified in other countries, most of them in Germany.

Kava extracts are not regulated as drugs in many countries. France, the United Kingdom and the United States have all taken different actions in the control of kava extract. Switzerland will decide on further action with respect to the ethanolic extract after examining the new international data.

to previous section
to next section
 
 
The WHO Essential Medicines and Health Products Information Portal was designed and is maintained by Human Info NGO. Last updated: June 25, 2014