Germany Bans Kava, Says Herb Can Damage Liver

By Ned Stafford

FRANKFURT (Reuters Health) - Germany's Federal Institute for Drugs and Medical Devices (BfArM) Monday announced a ban on the sale of the herbal medicine kava, to take effect immediately. The BfArM, which is Germany's version of the US Food and Drug Administration , said that kava can have extremely dangerous effects on the liver, especially at high doses.

In a statement, BfArM said that it was aware of more than 40 cases of severe liver toxicity with suspected links to consumption of kava, a substance also known as kava kava or Piper methysticum that has become increasingly popular in the US and Europe as a sedative, muscle relaxant and diuretic.

Of those 40 cases, six led to complete liver failure that required an organ transplant and three cases resulted in death, BfArM said. But it noted that in "many other cases, livers were able to recover after kava use was stopped."

Under Monday's ruling, the sale of kava will still be allowed in homeopathic products that contain only minute amounts.

BfArM said that any patients currently taking kava as a treatment can stop immediately without risk. BfArM advised any patients taking kava as a treatment against stress or anxiety to consult with a physician for an alternative medicine.

BfArM in November issued a preliminary ruling to ban the sale of kava except in products that contain only minute amounts. That ruling was appealed in December by the German Medicines Manufacturers' Association (BAH), which represents nearly 50 companies that produce kava products.

Ulrich Hagemann, deputy head of BfArM's pharmacovigilance unit in Bonn, told Reuters Health in January that as part of the BAH's appeal, the organization had recommended that kava become a prescription-only drug. The BAH's thinking was that it would be better to sell kava through prescriptions only than to have an outright ban.

An expert committee that advises the German government on prescription drugs in late January recommended that kava become a prescription-only product. But that recommendation, which was scheduled to take effect July 1, was separate from the BAH appeal before BfArM, which has ultimate authority to approve the sale of drugs in Germany.

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This article posted August 24, 2002.