http://www.pharmazeutische-zeitung.de/index.php?id=57279
"The Federal Institute for Drugs and Medical Devices (BfArM) will not try to withdraw the authorization for kava kava-containing medications.This was announced by the Authority upon request.Background is a dispute between the BfArM and several pharmaceutical companies that manufacture products with the herbal anxiolytic Kava Kava.In 2007, the BfArM had revoked the approval Kava-Kava-containing and kavain-containing medication after taking this medication with severe liver damage in connection had been taken.On the other hand, however, manufacturers had successfully sued before the Administrative Court of Cologne.An appeal of the BfArM against the Cologne ruling rejected the Higher Administrative Court (OVG) North Rhine-Westphalia until the end of February 2015 back.The judge vacate the judgment for reasons now submitted Although a quite that kava kava preparations currently demonstrated an unfavorable risk-benefit ratio have, so patients could hurt quite.However, this fact does not justify withdrawal of approval.Instead, these should be changed so that risks are future minimized by proper application.Thus, the latter based at BfArM Commission E recently self-determined specifications recommended: Patients should get kava kava preparations therefore only with a prescription and a maximum of two months in a take dosage of 60-120 kavapyrones.Also need to be reviewed during the treatment continued while the liver of the patient.Before taking should neither liver disease or -vorschädigung be, nor should the patient swallow or drink much alcohol potentially hepatotoxic drugs such as beta blockers, antidepressants and migraine drugs.In all cases in which patients were demonstrably harmed by kava kava preparations at least one of these risk factors have been present, argue the judges.a sensible alternative to other psychotropic drugs such as antidepressants or benzodiazepines case of slight presented to moderate generalized anxiety disorder kava kava preparations is, says the court ruling.For severe anxiety disorders or depression that means is, however, not suitable.The BfArM will now insert Although no further appeal against the decision of the court, according to a spokesman.With regard to the safety of patients, however, it planned measures to limit the risks of kava kava ingestion.As these rules look like the BfArM will announce in a timely manner.(Ah)02.04.2015 l PZPhoto: Fotolia / Heike Rau" [google translate]
"The Federal Institute for Drugs and Medical Devices (BfArM) will not try to withdraw the authorization for kava kava-containing medications.This was announced by the Authority upon request.Background is a dispute between the BfArM and several pharmaceutical companies that manufacture products with the herbal anxiolytic Kava Kava.In 2007, the BfArM had revoked the approval Kava-Kava-containing and kavain-containing medication after taking this medication with severe liver damage in connection had been taken.On the other hand, however, manufacturers had successfully sued before the Administrative Court of Cologne.An appeal of the BfArM against the Cologne ruling rejected the Higher Administrative Court (OVG) North Rhine-Westphalia until the end of February 2015 back.The judge vacate the judgment for reasons now submitted Although a quite that kava kava preparations currently demonstrated an unfavorable risk-benefit ratio have, so patients could hurt quite.However, this fact does not justify withdrawal of approval.Instead, these should be changed so that risks are future minimized by proper application.Thus, the latter based at BfArM Commission E recently self-determined specifications recommended: Patients should get kava kava preparations therefore only with a prescription and a maximum of two months in a take dosage of 60-120 kavapyrones.Also need to be reviewed during the treatment continued while the liver of the patient.Before taking should neither liver disease or -vorschädigung be, nor should the patient swallow or drink much alcohol potentially hepatotoxic drugs such as beta blockers, antidepressants and migraine drugs.In all cases in which patients were demonstrably harmed by kava kava preparations at least one of these risk factors have been present, argue the judges.a sensible alternative to other psychotropic drugs such as antidepressants or benzodiazepines case of slight presented to moderate generalized anxiety disorder kava kava preparations is, says the court ruling.For severe anxiety disorders or depression that means is, however, not suitable.The BfArM will now insert Although no further appeal against the decision of the court, according to a spokesman.With regard to the safety of patients, however, it planned measures to limit the risks of kava kava ingestion.As these rules look like the BfArM will announce in a timely manner.(Ah)02.04.2015 l PZPhoto: Fotolia / Heike Rau" [google translate]
