Underground branched rootstock (the rhizome) of the kava plant.
The drug, which was previously specified in the German Drug Codex (DAC), may no longer be used medicinally. The Federal Ministry for Drugs and Medical Devices (BfArM) definitively ordered the revocation of marketing authorizations for medicinal products containing kava kava in a decision dated December 20, 2019. Based on the scientific assessment of the Committee for Herbal Medicinal Products(HMPC) of the European Medicines Agency, the benefit-risk ratio is assessed as unfavorable.
HMPC: In 2017 it was decided that the risk exceeds the benefit due to liver damage. Authorization definitely revoked on 20.12.2019.
ESCOP monograph: indicated liver toxicity. Indication: anxiety states, states of tension and restlessness of non-psychotic origin.
Commission e-monograph: nervous states of anxiety, tension and restlessness.