מתוך medicontext.co.il
By Ned Stafford
FRANKFURT, Germany (Reuters Health) – An expert committee that advises the German government on prescription drugs has recommended that the herbal medicine kava kava become a prescription-only product in Germany.
Kava kava, which is used as a sedative, muscle relaxant and diuretic, is under increased scrutiny in Germany after 24 reports of severe liver toxicity, which resulted in at least one death and required at least three people to undergo liver transplants.
German Federal Institute for Drugs and Medical Devices (BfArM) in November issued a preliminary ruling to ban the sale of kava 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 who produce kava products.
Ulrich Hagemann, deputy head of BfArM's pharmacovigilance unit in Bonn, told Reuters Health on Monday that as part of the BAH's appeal, they had recommended that kava kava become a prescription-only drug. The association's thinking is that it would be better to sell kava kava through prescriptions than to have an outright ban.
Hagemann said that the expert committee's recommendation now goes to the Health Ministry, which has authority to oppose the recommendation. But he said that the Health Ministry normally accepts recommendations, and that he expects kava kava to become a prescription only drug in Germany beginning July 1.
He said BfArM ruling to ban kava kava is a totally separate issue, and that officials were still studying the appeal against a ban by the BAH. A decision is expected in February, he said. He added that making kava kava a prescription-only drug might decrease the risk of patients taking high doses
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