This gives us a chance -- they have already looked at it and recommended labelling only -- no reclassification from food to drug...
Joerg, you MUST give up on the idea of Rx -- it is essentially a ban in most countries -- if you are batting globally, then you must think global... anything less is a sell-out of major proportions.
I personally supplied Dr Stewart Jessamine, Principal [medical] Technical Specialist, Medsafe and the Minister's delegate, Dr Bob Boyd, with safety data on Kava -- they had also got most of it for themselves.
If you can't get the bans lifted with NZ's involvement then something is terribly, terribly wrong... There would be a revolution in NZ if kava were banned -- it is a daily part of the large Polynesian community's life, and there are significant supplement sales too.
Again, I beg you -- DO NOT SELL KAVA DOWN THE DRAIN -- Rx is being sold down the drain!! (am I shouting -- just a little bit.)
Regards
Ron Law
Extract from Sept 2002:
Kava and liver toxicity
Reference material
German Federal Institute for Drugs and Medical Devices (June, 2002) Kava Assessment Report.
Campo et al. (2002) Kava-induced fulminant hepatic failure. J Am Acad Child Adolesc Psychiatry, 41(6), 631.
Escher et al. (2001) Hepatitis associated with kava, a herbal remedy for anxiety. BMJ, 322, 139.
TGA Media Release (August, 2002) Recall of kava-containing OTCs.
ADRU (February, 2002) Review of 'Report on kava and liver damage'.
MCA (July 2002) Consultation document on prohibition of kava in unlicensed medicines.
WHO Information Exchange (June, 2002) Kava-containing products withdrawn in Germany.
FDA Consumer Advisory (March, 2002) Kava-containing dietary supplements may be associated with severe liver injury.
FDA Letter to Health Care Professionals (March, 2002)
Fast News (July 2002) Singapore joins growing list banning South Pacific herb, kava.
Health & Herbs International (August 2002) Kava.
Medsafe (drafted March, 2002) Possible consumer advice on kava-containing dietary supplements.
Waller, D (2002) Report on kava and liver damage. (including the following case reports: ARMS# 13198, ARMS# 14538, ARMS# 14723, ARMS# 15035, ARMS# 15267).
Schmidt, M (2001) Analysis of kava side effect reports concerning the liver (translation of German to English).
MCA (2002) Data relating to case reports of suspected hepatotoxicity associated with kava-kava.
Traditional Medicines Evaluation Committee (2002) Response to concerns
about Piper methysticum Forst. F., Kava.
Health Canada - Advice regarding products containing kava (January/August, 2002).
Ovid bibliographic records search for 'Kava'. Abstracts regarding efficacy and adverse effects. Pittler & Ernst (2002) Kava extract for treating anxiety. The Cochrane database of systematic reviews, Issue 3. Natural Products Industry Centre News Release, No basis for stop-sale order for Kava products. August 2002 American Herbal Products Association, Kava product warning label. March 2002.
Issue
The recent association of kava and serious hepatotoxicity (primarily based on case reports from Germany) has prompted some regulatory agencies (Germany, Switzerland, France, Portugal, UK, USA, Canada, Australia and Singapore) to warn consumers and/or take action to remove kava-containing products from the market.
The New Zealand Food Safety Authority requested that the MARC provide advice on the following:
Are there enough data available to enable the safety of kava-containing products to be determined?
If a significant safety issue is deemed to be apparent, what action (if any) does the MARC recommend in order to reduce the risk of adverse events?
Discussion
Members took note of the fact that Medsafe has kept a watching brief on kava-associated liver damage since the reporting of the German case-reports in 2001. The Committee noted that no cases of hepatic injury associated with kava have been reported in New Zealand. Members also noted that, while it is not known in detail which formulations of kava-containing products are available in New Zealand, hepatotoxicity has been reported with ethanolic, methanolic, acetone, and concentrated aqueous extracts. Members noted that in many of the case reports from other countries, patients were concomitantly taking other medications that could in themselves lead to liver toxicity. In general, members agreed that on the basis of the available case reports, the association between kava-containing extracts and hepatotoxicity is not strong. It was also noted that there is some evidence for the efficacy of kava as an anxiolytic.
Action
The Committee recommended to the New Zealand Food Safety Authority that labels, warning against the possibility of serious liver damage, should be required for kava-containing products.
Members also requested that the CARM keep a watching brief on this issue and
that Medsafe provide comment in a Prescriber Update issue, reminding prescribers
to consider herbal medicines as a possible cause of adverse effects.
Extract from Dec 2002:
Minute item 4.2 Kava and liver toxicity
The Committee agreed that labels, warning against the possibility of serious liver damage, should be required for kava-containing products. Members recommended that Medsafe write a letter to the New Zealand Food Safety Authority (NZFSA) informing them of this recommendation.
The Committee also advised that Medsafe provide comment in Prescriber Update, reminding prescribers to consider herbal medicines as a possible cause of adverse effects.
In early October, a letter was sent to the Principal Advisor at the NZFSA advising the NZFSA of the MARC's recommendation (but informing them that the recommendation had not yet been ratified by the Minister of Health's Delegate). A further letter was sent to the CEO of the NZFSA in November, re-stating the MARC's recommendation and informing them that it has now been approved by the Minister's Delegate.
A reminder regarding herbal medicines and adverse effects will be published in the next issue of Prescriber Update, which is planned for April 2003.
Discussion
Members noted the above and agreed that no further action is necessary at this time.
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