Medicinal products containing kava-kava: risk of severe hepatic injury, alterations of the marketing authorisations concerned
2019.12.23
Active substance: kava-kava
Medicines concerned: Kava-Kava (Piper methysticum)-containing and kavain-containing medicinal products including homeopathic preparations with a final concentration up to and including D4.
23.12.2019 - Revocation of marketing authorisations for medicinal products containing kava kava
The Federal Institute for Drugs and Medical Devices (BfArM) has ordered the revocation of the marketing authorisations of kava kava-containing drugs in a notice dated 20 December 2019.
23.08.2019 - Renewed hearing in the national graduated plan procedure ("Stufenplanverfahren")
Renewed consultation on kava kava-containing drugs, as the HMPC considers the risk-benefit ratio to be unfavourable.
04.06.2019 - Decision of the Cologne Administrative Court
In its decision of 22 January 2019, the Cologne Administrative Court mostly confirms the legality of the measures ruled in the notice of 28 August 2015. Thus, it merely differs from the BfArM's assessment in that it considers control of the liver values prior to treatment, after 1, 2, 4, 6 and 8 weeks to be sufficient and does not consider the use of educational material to be necessary. The Court's ruling is not yet final.
31.08.2015 - Notice within the graduated plan procedure ("Stufenplanverfahren")
In its notice of 27 August 2015, the BfArM has ruled measures altering the marketing authorisations concerned.
(available in Germen only)
07.04.2015 - Hearing within the graduated plan procedure ("Stufenplanverfahren")
Dated 25 February 2015, the Higher Administrative Court of North Rhine-Westphalia has ruled to overturn the BfArM's decision from the end of 2007 to revoke the marketing authorisations of the above-mentioned medicinal products.
(available in German only)
21.12.2007 – Revocation of marketing authorisations/registrations
On 21 December 2007, the Federal Institute for Drugs and Medical Devices (BfArM) ruled revocation of marketing authorisations/registrations.
(all documents available in Germen only)
Further information
For details on the procedure please click on the following link to the homepage of the European Medicines Agency (EMA):