[india-drug] Kava-Kava and Kavaine containing products

[owner-india-drug@usa.healthnet.org]

Kava-Kava and Kavaine containing products withdrawn in Germany due to
hepatotoxic risks

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The Federal Institute in Germany has notified the Marketing
Authorization Holders that as of 17' June 2001 all kava-kava and
kavaine containing products will be withdrawn from the German market
due to hepatotoxic risks and insufficiently proven efficacy of these
products. This withdrawal is also effective for all homeopathic
dilutions up to D4.

Regulators have helped arrive at the above decision after carefully
reviewing all available evidence for serious hepatotoxicity, including
hepatitis, cirrhosis and liver failure with kava products in Germany.

Other measures taken elsewhere in the world include:

1.   Removal of acetone kava root extract preparations from the Swiss
market following reports of severe hepatic complications. Kava ethanol
extract products as well as a ?synthetic preparation containing d - / l
? kavaine with a seemingly lower incidence of liver reactions were
allowed to remain on the market. However, the kava ethanol extract
preparations were moved from OTC category to 'pharmacy only' status.

2.  Voluntary withdrawal of all kava-containing products by UK
companies, a move encouraged by the Medicines Control Agency (MCA) in
the UK. The Irish industry initiated a similar move in Ireland, in
consultation with the Irish Medicines Board.

3.  Consumer warning issued by Health Canada to consumers to refrain
from using kava products pending safety assessment.

4.  Consumer advisory issued by the US PDA, warning about the potential
of liver injury with the use of kava-containing products.

The German regulation applies to all kava-containing pharmaceutical
formulations. However, the natural form of kava continues to be
available and is consumed in several Western Pacific countries.




Reference given in Alert No.105, Information Exchange System, World
Health organisation :

1.	Facsimile message from Pharmacovigilance Division, Federal Institute
for Drugs and Medical Devices, BfArM, Germany, dated 17 June, 2002. 
2.	The WHO Pharmaceuticals Newsletter, Issues I & 2,2002.




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