Revoke approvals from Kava-Kava

Revoke kava-kava (up to a homeopathic dilution of D4) for hepatotoxic reactions

06/25/2014

The Federal Institute for Drugs and Medical Devices (BfArM) had revoked the authorizations of kava-kava (up to a homeopathic dilution of D4) for alleged hepatotoxic reactions. After a long dispute between drug manufacturers and the BfArM, there is now a new verdict: The VG Cologne declares the revocation of the license as unlawful.

Already in 2001, the BfArM initiated a phased plan procedure based on reports of suspected side effects in the form of liver toxicity effects in the case of acetone kava extracts. This was followed by the revocation of the phytopharmaceutical approvals with the Kava-Kava rootstock dry extract and a long-running dispute between the authorities and the companies concerned. The BfArM revoked the approvals in December 2007 again. Several manufacturers complained. Now the first judgments are available.

Benefit-risk ratio of kava kava not unfavorable
The court considers the complaints of the manufacturers to be justified. It states that a drug license should be revoked if the benefit-risk ratio of the drug proves to be unfavorable. In the present case this is not the case.

Referring in detail to the submitted monographs, studies and case reports (in particular the WHO), the General Court states in detail that the conditions for the revocation of the authorizations were not fulfilled.

Benzodiazepines no lower-risk alternative
The court also does not consider benzodiazepine-containing drugs, which overlap with kava-kava in the field of application, to be a risk-averse alternative. In addition, the abuse rate for benzodiazepines is too high.

Will BfArM appeal??
The court has admitted the appeal. It remains to be seen whether the BfArM will appeal. The verdict of the VG Cologne you can see here. (Pm)