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Another end for kava-kava medication
The Federal Institute for Drugs and Medical Devices (BfArM) recently announced that the approval of medicinal products containing kava-kava will be revoked again. Due to the risk of severe liver reactions, the benefit-risk ratio is unfavorable. The revocation also includes homeopathic preparations.
In a communication dated December 23, 2019, the BfArM announced the withdrawal of all medicinal products containing kava-kava (Piper methysticum). The revocation also includes all medicinal products containing cava and all homeopathic remedies with a final concentration up to and including D4.
What is kava kava?
The botanical name of kava is Piper methysticum. In Germany, the plant is also known as the intoxication pepper. The active ingredient kava-kava is said to have relaxing and anxiolytic effects. In Germany, extracts of the plant have been used in herbal medicines and homeopathic remedies.
Serious side effects have been known for a long time
As early as 2002, the Federal Institute for Risk Assessment and the Federal Institute for Consumer Health Protection and Veterinary Medicine (BgVV) warned of products containing kava-kava. Regular intake can lead to severe liver infections and permanent liver damage.
Back and forth in the lawsuit over Kava-Kava
In June 2002, the BfArM already revoked all approvals for medicinal products containing kava-kava and kavain. The medicines were not prescription-only at that time. 32 cases of liver damage to liver failure with fatal outcome have been associated with the medication.
Some manufacturers doubted the causality of the suspected cases and took action against the judgment. The Higher Administrative Court of North Rhine-Westphalia confirmed the plaintiffs and partially revoked the revocation of the license in February 2015. Medicines containing kava-kava were allowed to be sold again under more stringent conditions.
First, a prescription for the drugs was introduced. In addition, the maximum daily dose should not exceed 120 milligrams of Kavapyrone and a package should not contain more than 30 individual doses. The duration of treatment was also set to a maximum of two months. In addition, regular liver function tests had to be performed before and during treatment.
In 2019, the proceedings were heard again. "As part of the work to create a European plant monograph, the Committee for Herbal Medicines (HMPC) of the European Medicines Agency has carried out a detailed assessment of the benefit-risk balance of medicinal products containing kava-kava and has summarized them as unfavorable," writes the BfArM . On December 20, the decision was made to revoke the approvals for medicinal products containing kava-kava. (vb)
Author and source information
This text corresponds to the specifications of the medical literature, medical guidelines and current studies and has been checked by medical doctors.
Graduate editor (FH) Volker Blasek
- Federal Institute for Drugs and Medical Devices (BfArM): Medicinal products containing kava-kava: risk of severe liver reactions, revocation of the relevant approvals (access: 23.12.2019), bfarm.de
- European Medicines Agency: Piperis methystici rhizoma (accessed: December 23, 2019), ema.europa.eu
- Federal Institute for Risk Assessment (BfR): BgVV warns of products containing kava-kava (accessed: December 23, 2019), bfr.bund.de.