Update 3: Kava-Kava
Siehe
"The 2002 decision to temporarily inactivate kava registrations was based on a classic drug review process of a risk-benefit evaluation. In its review of kava safety and efficacy studies, as well as the adverse event reports, the BfArM came to the somewhat surprising conclusion that there was a lack of adequate proof of anxiolytic (anxiety-reducing) efficacy of kava products; BfArM made this assessment because it determined that all existing clinical studies were either conducted with higher doses of kava than allowed within the respective products’ official drug registrations with the government, were used in indications that were not consistent with the approved registrations, or had been the subject of a non-controlled clinical study.2 The producers have been asked to provide new clinical data until June 2007, in which case a reinstitution of the kava products on the market might again be possible."
Quelle:
Hawaiian Kava Forum
'Awa Development Council
The Kava Festival
"The 2002 decision to temporarily inactivate kava registrations was based on a classic drug review process of a risk-benefit evaluation. In its review of kava safety and efficacy studies, as well as the adverse event reports, the BfArM came to the somewhat surprising conclusion that there was a lack of adequate proof of anxiolytic (anxiety-reducing) efficacy of kava products; BfArM made this assessment because it determined that all existing clinical studies were either conducted with higher doses of kava than allowed within the respective products’ official drug registrations with the government, were used in indications that were not consistent with the approved registrations, or had been the subject of a non-controlled clinical study.2 The producers have been asked to provide new clinical data until June 2007, in which case a reinstitution of the kava products on the market might again be possible."
Quelle:
Hawaiian Kava Forum
'Awa Development Council
The Kava Festival
Morgaine - 5. Mär, 14:12
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