In early 2002, The US Food And Drug Administration (FDA) began advising consumers of the potential risk of severe liver injury associated with the use of kava-containing dietary supplements. Kava (Piper methysticum) is a plant indigenous to the South Pacific Islands, where it is commonly used to prepare a traditional beverage for social and recreational purposes. Dietary supplements containing the herbal ingredient kava are promoted for relaxation to relieve stress, anxiety, and tension, as well as for sleeplessness and menopausal symptoms. Kava-containing products have been associated with rare liver injuries in Western countries, and the FDA urged consumers and health care professionals to report any case of liver injury that may be related to the use of kava-containing dietary supplements. The FDA also announced its intention to further investigate the relationship, if any, between the use of dietary supplements containing kava and liver injury, which included attempting to determine a biological explanation for the relationship and to identify the different sources of kava in the United States and Europe.
Tag Archive for ‘kava’
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Kava chalcone induces apoptosis reduces tumor growth
Flavokawain B, a kava chalcone, induces apoptosis via up-regulation of death-receptor 5 and Bim expression in androgen receptor negative, hormonal refractory prostate cancer cell lines and reduces tumor growth
Recent ‘Awa (Kava Kava) Harvest
Uaka Kava of Hilo Hawaii have recently restocked ‘Awa (Kava Kava) powder they make from the dried fresh root of the Mahakea variety grown on the Big Island. This powder is for sale on their website:
http://www.mauikava.com
There still continues to be a shortage of fresh root due to the disruption in planting caused by BfArM (German Federal Institute for Drugs and Medical Devices) erroneously linking fresh ‘Awa root to liver damage in 2001. This was subsequently disproved by UH Scientists:
A team of University of Hawai’i scientists may have solved the mystery of why some Europeans who used products containing kava extract suffered severe liver damage, prompting a number of nations to ban sales of the herbal supplement.
Read Complete Honolulu Advertiser article . . .
There have actually been reports of health benefits from using ‘Awa root:
American Association for Cancer Research
Fiji Times
When the supply is normal Uka Kava makes dried fresh root powder processed from these varieties:
‘Awa Hanakapi ‘ai
‘Awa Hiwa
‘Awa Honokane Iki
‘Awa Kumakua
‘Awa Mahakea
‘Awa Mapulehu
‘Awa Pana’ewa
‘Awa Mo’i
‘Awa Nene
‘Awa ‘Opihikao
‘Awa Papa ‘Ele’ele
‘Awa Papa Kea
‘Awa Papa’ Ele’ele Pu’upu’u
During fresh root shortages Uka Kava offers their “Hang Loose Instant Kawa” product which many people prefer anyway due to ease of preparation.
Uka Kava also has a Woodworking Division which produces bowls and other objects made from exotic local woods such as Koa, Milo, Pride of India (China berry), and Norfolk pine.
‘Awa Website Shopping Cart Updated
MauiKava.com has updated their shopping cart to conform to new book, Hawaiian ‘Awa Views of an Ethnobotanical Treasure (Edited by Ed Johnston and Helen Rogers), ‘Awa Cultivar naming conventions.
The Introduction is posted HERE
Uka Kava, the Hilo Hawaii based parent company of MauiKava.com, sells 16 different cultivars in season of which 6 Hawaiian type required name changes to be consistent with the new publication which is the definitive guide.
Hawaiian ‘Awa–Views of an Ethnobotanical Treasure
Hawaiian ‘Awa Views of an Ethnobotanical Treasure
Edited by Ed Johnston and Helen Rogers. This is the definitive guide to the cultural-historical, ingredients, chemistry, cultivars, preparation, production and integrated pest management for ‘Awa (kava kava or Piper methysticum) has been published by the Association for Hawaiian ‘Ava. This is an indispensable resource to anyone interested in the topic.
Fiji Times–New research in Scotland and Luxembourg has found that kava is a cure for two types of cancers.
RESEARCHERS who discovered that kava is a cure for two types of cancer should convince Europe to lift its ban, says Agriculture Minister Ilaitia Tuisese. He was commenting on the research findings of the University of Aberdeen in Scotland and the Laboratoire de Biologie Moleculaire du Cancer, a medical school in Luxembourgh which found that kava compounds inhibit the activation of a nuclear factor important in the production of cancer cells.
“It’s good news but there’s a ban in the European market and right now we can’t look forward to speeding up on the yaqona (kava) production,” Mr Tuisese said.
“Perhaps they (researchers) can help us convince the European market and assist in lifting the ban. The latest findings confirm what people have been saying all along that kava was not harmful to health.”
Epidemiology and Prevention
Kava extracts found to cause strong antiproliferative and apoptotic (programmed cell death) effects in human bladder cancer cells and also suppresses tumor growth in mice.
Fiji Times–New hope for kava industry
AS pressure mounts on European and other countries to lift the ban placed on kava imports, the experts and producers of kava around the Pacific are joining forces to publicise the benefits of this age-old root plant to offset any negativity. Holding the helm of this counter-publicity drive in Fiji are the University of South Pacific Professor of Organic Chemistry Subramaniam Sotheeswaran and Kadavu chief Ratu Josateki Nawalowalo.
“In a recent study in collaboration with the organic chemists at the USP, the Saitama Cancer Centre Research Institute in Japan, has shown that kava may have promising anti cancer activity paralleling the anti-cancer activity of green tea,” Prof Sotheeswaran told the Sunday Times.
A study into the kava industry has found that there was no basis for the market recalls or restriction on kava
A study into the kava industry has found that there was no basis for the market recalls or restriction on kava by health agencies in Europe in 2001, a move that soon crippled Pacific Island kava exports to Europe and other major overseas markets.
UH scientists may have solved kava mystery
By Kevin Dayton
Advertiser Big Island Bureau
HILO, Hawai’i — A team of University of Hawai’i scientists may have solved the mystery of why some Europeans who used products containing kava extract suffered severe liver damage, prompting a number of nations to ban sales of the herbal supplement.
The culprit may be a compound found in the stem peelings and leaves of the kava plant — known in Hawai’i as ‘awa — but not in the roots that are used to make the traditional kava drink consumed by Pacific Islanders.
Just to be safe, people should avoid tea or anything else made from the leaves or stems of the plant, according to C.S. Tang, professor of molecular biosciences and biosystems engineering at UH-Manoa.
Bans in Singapore, Germany, Canada, the United Kingdom and elsewhere wiped out pharmaceutical sales of kava and virtually destroyed it as an export crop in Hawai’i. While kava supplements are not banned in the United States, the Food and Drug Administration issued an advisory in March 2002 warning of the potential risk of severe liver injury from dietary supplements containing kava.
The health alarms left farmers in Hamakua and elsewhere with crops that were hardly worth harvesting.
The Future of Hawaii’s commercial ‘Awa industry
STRATEGIES for saving Hawaii’s commercial kava industry
1) Promotion of Kava
- Put stories in the press about kava
- Participate in educational/tasting events, tell the kava story
- Hold annual kava festival
2) Increase public access to kava beverage
- Open more kava cafes- at least 6 in US (Honolulu, Hilo, Kona, Maui?, Eugene, OR, Baca Raton, FL
- Move into other food /beverage venues–cafes, Starbucks, Jamba juice, internet caf?
- Develop a Small business innovative research grant; for Kava beverage making machine because hand squeezing limits production, raises labor costs. Proposals have been submitted by AHA, Puu Hoku Ranch
- Develop a grant to develop a kava beverage that is shelf-stable product; (check with Lebot if he can share his formula particularly amylase enzyme use.
Analysis of Kava Side Effects Reports Concerning the Liver
Translation to English by Lindenmaier M and Brinckmann J
31. December 2001
Analysis of hepatotoxic reactions listed by the BfArM (German Federal Institute for Drugs and Medical Devices)
| The BfArM has recently informed industry and media about reported side effects that may be associated with the ingestion of kava preparations (2;3). In this preliminary information, it is stated that the Institute proposes to revoke marketing authorization for kava -containing drugs including homeopathic preparations with a final concentration of D6. Henceforth, the manufacturers have been given the opportunity, within 4 weeks time of receipt of the letter, to respond with its position concerning the proposed measures.Even though the announcements are rather serious, the need for urgency comes as a surprise: with regard to the drug safety protocol developed in Switzerland in 2000, of which the German health authorities also had knowledge of, the information status has not fundamentally changed. Yet on October 19, 2000, theGerman health authorities stated in a 10 part report that the BfArM had no intentions of conducting a new risk evaluation for kava products in Germany (1). ???
The announcement of a drug safety protocol through the BfArM was based on a listing of 24 cases of side effects in connection with serious hepatotoxic effects ranging up to liver failure, (cholestatic) hepatitis or cirrhosis of the liver. In 18 of these cases, the BfArM classified an association with kava as probable or possible. In one case, the adverse effect on the liver was fatal. Five cases were without any concomitant medication. Two reports couldnot be evaluated due a lack of clinical data. Also, in the cases involvingco-medication, the BfArM considered kava to be responsible for the side effect. Serological investigations, as far as they were carried out, were negative in all cases. Closer inspection of the presented cases provides, however, another outcome andraises considerable questions with regard to the BfArM accuracy or carefulness in association with sensible procedures. For example, the report regarding virus serology is misleading: such investigations were conducted in only the fewest of cases, and these were primarily the ones reported in Switzerland. The adverse event case reports from Switzerland are collectively characterized as being representative, while the evaluation of the listings bythe BfArM is far from compliance with the current standards required to fulfill relevant European guidelines. When one examines the reactions in detail, it appears that the BfArM’s classification of causality linked to kava, is, to a large extent, incomprehensible, and arbitrary. Moreover, in its evaluation of cases, the BfArM had not taken into consideration various existing pieces of information, for example those with regard to other possible causes. One extreme example may be concerning the aforementioned lethal case: in this instance, it was known to the Institute that the cause of liver failure was several years of alcoholabuse, and that kava was not involved in the genesis of the liver symptoms. The autopsy had shown that the cirrhotic process had already started long before the adminstration of kava began! The second, internal listing documented that this circumstance was known to the BfArM, but this listing has not been made accessible to the manufacturers for use in rebuttal statements regarding the notice of possible marketing revocation. This second listing contained a compilation of all known suspected cases (32 in all), including those reported in Switzerland and those published in the literature. This listing is indeed carefully conveyed as being an ?official? paper, however it still contains a range of obvious errors. Because the ?non-official? second listing of the BfArM is complete in regard to the sources referred to in this evaluation, the 24 reports of side effects initially reported by BfArM are consequently not being used as the basis of discussion, but rather the 32 cases that were entered into the second listing. In addition to the BfArM’s two listings, other sources of information for the present case evaluation include the Interkantonalen Kontrollstelle (IKS) der Schweiz (Swiss Intercantonal Agency for Control of Medicines), the pharmacovigilance databank of the WHO, as well as concerned product manufacturers.The listing of cases that are suspected to be kava-related by the Arzneimittelkomission der deutschen ?rzteschaft (AKD?) (Drug Commission of the German Physician’s Association) is not included. The AKD?’s listing of the most recent adverse event reports contains no indications of liver toxicity from kava products. Moreover, theAKD? does not release the product names publicly, which prevents a meaningful use of the data a priori.? |
Analysis of Kava Side Effects Reports Concerning the Liver–Total Listed Cases
Translation to English by Lindenmaier M and Brinckmann J
31. December 2001
Analysis of hepatotoxic reactions listed by the BfArM (German Federal Institute for Drugs and Medical Devices)
1. Total Listed Cases
Referring to the non-official second listing of the BfArM as a foundation, there is a database of 32 side effect reports, including those reported by the Swiss health authorities (IKS), the WHO, as well as those cases described in the medical literature. The number of 32 reports is of course not synonymous to 32 cases of confirmed causality. The list contains duplicate reports and questionable classifications. When one collects all the available data for the individual cases, one arrives inevitably at another evaluation of the data.
2. Duplicate Entries
With a more accurate observation of the case reports listed by the BfArM, one finds a range of duplicate entries. Obviously, the duplicate entries were not reconciled against each other when the information was obtained from different sources. Therefore, the report of one and the same case can lead to a threefold entry, if, on the one hand, the event is reported directly from the patient, and on the other hand, the event is also reported via the manufacturer’s duty of notification, and finally, the treating phyisician also turns in a case report. These redundant data entries are not only difficult to recognize, but the inflated number of cases has led to a shift in the risk evaluation for a drug substance. In the case of the BfArM listings, mistakes in data transfer have exacerbated this situation.
READ COMPLETE ARTICLE HERE
Analysis of Kava Side Effects Reports Concerning the Liver–Causal relationship with concomitant medication probable
Causal relationship with concomitant medication probable
- In the causality evaluation of suspected cases of undesired drug effects, influences from the co-medication may possibly be involved. In its press release, the BfArM intentionally emphasized that 18 of the 24 cases were attributed to kava, in spite of a known causal relationship with the co-medication. Upon closer inspection, this assessment by the BfArM appeared to be arbitrary: After subtracting the above mentioned cases and duplicate reports, 11 suspected cases remain. Due to the concomitant circumstances and the ingestion of other medications with known liver damaging potential, there is considerable doubt in respect to an objective portrayal of risk, in contrast to how this was portrayed in the press release.In principle, the participation of kava can not be absolutely ruled out, even if the co-medication provides solid evidence for other causes. Hence, the following registered cases are classified as ?improbable?.??
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Analysis of Kava Side Effects Reports Concerning the Liver–Doubtful Causality
Translation to English by Lindenmaier M and Brinckmann J
31. December 2001
Analysis of hepatotoxic reactions listed by the BfArM (German Federal Institute for Drugs and Medical Devices)
Three of the known suspected cases of kava-related hepatic side effects cannot be easily negated but a conclusive correlation is not possible. In the following cases, no co-medications, or only preparations without a known hepatotoxic potential, are listed. Based on the experiences from the previously listed cases, however, it should not be assumed that no suspicious co-medications were taken. The BfArM failed to list known co-medications in more than one case, but experiences with the handling of spontaneous side effect reports show that crucial information is often not obtainable due to poor cooperation by the patient. This dilemma of every drug safety protocol agent should, however, not automatically justify the classification of ?certain causality?, as it had been expressed by the BfArM in a press release.
Analysis of Kava Side Effects Reports Concerning the Liver–Causal relationship cannot be evaluated due to information status
Translation to English by Lindenmaier M and Brinckmann J
31. December 2001
Analysis of hepatotoxic reactions listed by the BfArM (German Federal Institute for Drugs and Medical Devices)
In six of the reports, the background information is so scarce that a complete evaluation of the case is not possible. In several cases, it is not even clear what type of side effects actually occurred. Reports of this kind can only be used as an argument to improve the pharmacovigilance process; if such kind of ?rumors? persist, these incidences will doubtlessly receive more attention.
