Merck Voluntarily Withdraws Kava Kava Products From the Market

30-Nov-2001

The current discussion of the risks involved with kava kava-containing medicinal products has prompted the Merck subsidiaries Merck dura GmbH and Merck Selbstmedikation GmbH, upon their individual responsibility, to withdraw from the market their two products available for sale in pharmacies, namely kavadura 120 mg and Kytta-Kava. This is a precautionary measure that takes effect on November 29, 2001.

The two products represent an annual sales volume of far less than half a million euros.

In the past years, 24 cases of suspected adverse effects on the liver have been reported to the German Federal Institute for Drugs and Medicinal Products. A possible correlation between the intake of kava preparations and the reported adverse reactions is at present being scientifically investigated and cannot be excluded.

Although there have so far been no indications of any such adverse effects with the two Merck products, for drug safety reasons Merck has been induced by the current discussion of risks to withdraw the two preparations from the market as a precaution.

The purely plant-based kava preparations are obtained from the rootstock of the kava pepper. Kava is a shrub that grows predominantly in Polynesia. Kava medicinal products are said to bring calm and relaxation to persons with physical exhaustion and nervous irritation, without any addictive or habit-forming properties.

Merck has marketed the non-prescription preparations Kytta-Kava since 1998 and kavadura since April 2001. Merck's kava-containing products are available only on the German market.

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