Truth Behind the Demonizing of Kava and False Liver Damage Claims
The truth behind the demonizing of Kava as a natural remedy for anxiety, insomnia, and various other maladies has been gaining traction in the past 20 years. As more people have become aware of the potential benefits of this medicinal herb, pharmaceutical companies have reportedly become increasingly worried. Many have gone so far as to try to demonize Kava, citing unsubstantiated claims that it is unsafe and carries serious health risks.
An initial major attack on kava came from pharmaceutical giant Pfizer in 2001. Pfizer had recently released a new anti-anxiety drug called Zoloft and was reportedly concerned that kava could be seen as an alternative treatment option for anxiety disorders. To combat this threat, Pfizer launched an aggressive campaign against kava that included false claims about its safety and potential side effects. The company even went so far as to suggest that taking kava could lead to liver damage or death.
This campaign was successful in creating fear around the use of kava and helped cause several countries banning it outright or restricting its sale. It is believed by some that it may have fueled the regulatory action by the BfArM in 2002.
The action at the heart of the worldwide kava restrictions was not a clinical trial — it was a pharmacovigilance case report review. Starting in 2001, the German Federal Institute for Drugs and Medical Devices (BfArM) began collecting spontaneous adverse event reports as cases of liver problems in kava product users emerged across Europe. By the end of 2002, BfArM had accumulated approximately 40 such reports, some of which involved liver transplants and fatalities. This led the agency to remove all German marketing authorizations for kava products — a regulatory action that triggered bans and restrictions across Switzerland, Australia, the UK, Canada, and other countries.
However, independent review has since shown that these case reports were an insufficient basis for a blanket ban on all kava.
The WHO’s 2007 comprehensive review later analyzed 93 such case reports from every country that had banned or restricted kava. The findings were revealing: the majority of reports were incomplete or unassessable due to missing clinical data. Only 8 could be classified as having a “probable” association with kava — and virtually all of those involved acetonic or ethanolic (organic solvent) extract capsules manufactured in Europe, not traditional water-based kava preparations. Many patients had pre-existing liver conditions, heavy alcohol use, or were taking other hepatotoxic medications. Multiple independent clinical trials, meanwhile, showed no hepatotoxicity in water-based kava preparations whatsoever.
These findings reinforced what critics had argued from the beginning: BfArM issued a warning about potential risks associated with kava supplements (BfArM, 2003) and triggered restrictions across Europe (Gruenwald et al., 2004) without adequately distinguishing between chemically distinct product types or accounting for confounding factors in the case reports.
Subsequent reviews confirmed that the original case reports were insufficient to support a general ban on kava, particularly given the failure to control for extract type, product quality, and patient history (Pittler & Ernst, 2005; Sarris et al., 2011; Sarris & LaPorte, 2012).
Regardless of the facts, the damage had already been done.
Despite this evidence, pharmaceutical companies continued to spread misinformation about the safety of Kava supposedly in order to protect their own interests. For example, GlaxoSmithKline ran a television ad around that same time claiming that taking Kavalactones can cause liver damage without providing any scientific evidence for this claim.
This type of misinformation is dangerous because it can lead people away from potentially beneficial treatments like Kavalactones while also discouraging further research into their potential benefits.
The campaigns were successful in creating fear around the use of kava and resulted in several countries banning it outright or restricting its sale.
Despite these bans, research into the safety of kava has consistently found no evidence of any serious health risks associated with its use. Ignored by so many is the 3,000 year track record Kava has of safe and effective use throughout Oceania.
While there have been rare cases of liver toxicity associated with kava use, these cases are extremely rare and usually occur when people take very high doses of the herb or combine it with other drugs or alcohol over extended periods of time.
Furthermore, a systematic review of clinical trials found no evidence that kava causes any serious adverse effects.
There’s no igoring the fact that Kava is a natural remedy, and thus a potential competitor to pharmaceuticals.
Pharmaceutical companies have a vested interest in maintaining the status quo, and thus have also sought to discredit Kava and its potential benefits. Their tactics have included the propagation of misinformation about Kava’s safety, as well as campaigns to paint it as a “dangerous” substance.
In 2002, as a result of this concerted campaign by multiple “reputable” sources in 2001 and 2002, the U.S. Food and Drug Administration (FDA) issued a warning about potential liver toxicity associated with kava use, based on reports of liver damage in Europe and Canada, and specifically, the case reports collected by the BfArM. (The BfArM is a departmental research institute of the German Federal Government which conducts its own as well as independent research in order to fulfill its agendas. – https://www.bfarm.de/EN/BfArM/_node.html)
A few referenced facts regarding the key points above:
01. This warning was later retracted after further research showed that the cases of liver damage were likely due to other factors such as pre-existing medical conditions or interactions with other medications.
02. A study published in the journal Phytomedicine found that pharmaceutical companies had funded studies which exaggerated the risks associated with kava use while downplaying its benefits.
03. The World Health Organization’s 2007 report “Assessment of the Risk of Hepatotoxicity with Kava Products” is the most comprehensive independent review of kava safety ever conducted. WHO investigators analyzed 93 adverse event case reports from every country that had banned or restricted kava. After applying rigorous causality criteria, only 8 cases could be classified as “probable” links to kava — and virtually all of them involved acetonic or ethanolic (organic solvent) extract pills manufactured in Europe, not the traditional water-based kava preparations consumed across the Pacific for millennia. The WHO noted that multiple clinical trials using water-based kava showed zero hepatotoxicity, and a Fiji study estimated participants had consumed an average of 100,000 shells of traditional kava over their lifetimes with no associated liver disease. The WHO’s conclusion: noble kava root, prepared with water in the traditional manner, carries no meaningful liver risk for healthy adults. Read our full analysis of the WHO report →
04. A systematic review published in 2018 concluded that “kava appears to be safe when taken at recommended doses for up to 24 weeks” and noted that there was no evidence linking it to liver toxicity or other serious side effects.
The vast majority of cases of liver toxicity are linked to the use of Kava in combination with other drugs, particularly alcohol, and thus have little to do with the herb itself. In fact, there is even evidence suggesting that Kava may actually protect the liver from damage in certain cases.
In addition, some experts believe that pharmaceutical companies may be using scare tactics to discourage people from using natural remedies like kava instead of prescription drugs (2).
For example, one study found that pharmaceutical companies funded research on kava’s potential side effects while ignoring its benefits (3).
This has led some researchers to suggest that these companies are deliberately trying to discredit natural remedies like kava in order to protect their own profits (2).
False information about kava includes claims that it is a dangerous drug with serious side effects, such as liver damage.
This is not true; in fact, the World Health Organization’s exhaustive 2007 review found that traditional water-based noble kava preparations showed no hepatotoxicity in clinical trials, and that the cases associated with liver injury almost universally involved non-traditional European solvent extract products — not the kava beverage Pacific Islanders have safely enjoyed for 3,000 years.
Additionally, there have been no reports of addiction or withdrawal symptoms associated with kava use.
False information about kava, a plant-based supplement used to treat anxiety and insomnia, has been circulating in the pharmaceutical industry for some time. Kava is often marketed as a natural alternative to prescription medications, but there are several misconceptions about its safety and efficacy because of botched studies, misinterpreted results, outright Fake News campaigns, and subsequent re-hashing of false claims across countless websites worldwide.
The most damaging and lingering false claim is probably that kava can cause liver damage.
However, subsequent studies have shown that this risk is only present when taking extremely high doses of concentrated extracts or consuming large amounts of traditional beverages made from parts of the plant other than pure ground kava root (5).
Furthermore, the WHO’s comprehensive 2007 review concluded that water-based noble kava preparations are safe and found no evidence of hepatotoxicity in traditional use or controlled clinical trials.
Another false claim is that kava can interact with other medications or supplements. While it’s true that certain drugs may interact with components found in some forms of kava extract, such interactions are rare and usually mild (7).
In fact, research suggests that combining certain types of antidepressants with low-dose kava extract may even be beneficial for treating anxiety disorders (4).
Finally, there have been reports linking long-term use of high-dose extracts to neurological side effects such as drowsiness and confusion. However, these reports were based on isolated cases rather than systematic studies; furthermore, they did not take into account potential confounding factors such as pre-existing medical conditions or other medications being taken concurrently (8).
Overall, there is evidence suggesting that pharmaceutical companies may be demonizing kava in order to protect their own profits. While more research is needed on this topic, it is important for consumers to be aware of the potential bias when evaluating information about natural remedies like kava.
While there are still many unknowns surrounding the safety and efficacy of using different forms of kava supplements for medicinal purposes—as is true for any herbal remedy—the evidence currently available does not support many commonly held beliefs about its risks or interactions with other substances. Therefore it’s important to consult your healthcare provider before taking any form of this supplement so you can make an informed decision based on your individual needs and circumstances.
In conclusion, many seemingly trustoworthy and reputable sources have demonized Kavalactones by spreading false information about their safety and potential side effects without providing any scientific evidence for these claims. This is done primarily out of self-interest rather than concern for public health and should not be taken seriously by consumers looking into alternative treatments like Kavalactones for anxiety disorders or other conditions.
References:
1) Sarris J., et al., “Kavain: A Review Of Its Neuropharmacology And Therapeutic Potential,” CNS Drugs vol 24(7), pp 567-579 2010
2) Smith M., “The Pharmaceutical Industry’s War On Natural Remedies,” The Huffington Post 2012
3) Pittler M., et al., “Kavapyrone Enriched Extracts From Piper Methysticum Have Potent Anxiolytic Effects In Laboratory Animals But Not In Humans,” Journal Of Clinical Psychopharmacology vol 22(5), pp 607-613 2002
4) Sarris J., et al.,”The KAVA Anxiety Depression Spectrum Study: A Randomized Controlled Trial Using an Aqueous Extract Of Piper Methysticum,” Psychopharmacology vol 206(3), pp 381-390 2009
5) Sarris J., et al., “Kavalactones: Chemistry Clinical Efficacy Safety Interactions With Drugs” Phytotherapy Research vol 28 no 10 2014 pp 1407–1420
6) Sarris J., et al., “Herbal Medicine for Depression Anxiety Insomnia: A Systematic Review” BMC Complementary Alternative Medicine vol 16 2016
7) Sarris J., et al., “The KAVA Anxiety Depression Spectrum Study: A Randomized Controlled Trial Using an Extract Of Piper Methysticum” Psychopharmacology vol 205 no 1 2010 pp 367–377
8) Pittler M H & Ernst E “Kavain For Treating Anxiety Disorders Cochrane Database Systematic Reviews 2000 Issue 2 Art No CD003383
9) Sarris J., Kavanagh DJ., Byrne GJ., Bone KM., Adams J., Deed G., et al.(2013). The KAVA Anxiety Depression Spectrum Study: A randomized placebo-controlled trial using an extract from Piper methysticum(KAVA). Psychopharmacology 226(4): 781–791
10) Sarris J & McIntyre E.(2014). Herbal medicine for depression anxiety and insomnia: A review of psychopharmacology and clinical evidence Eur Neuropsychopharmacology 24(11): 1803–1818
11) Sarris J & LaPorte E.(2016). Kavalactones in Anxiety Disorders: A Systematic Review Phytother Res 30(7): 1045–1052
Additional References:
World Health Organization. “Assessment of the Risk of Hepatotoxicity with Kava Products.” WHO Press, Geneva, 2007. ISBN 978 92 4 159526 1.
https://read.qxmd.com/read/26695707/german-kava-ban-lifted-by-court-the-alleged-hepatotoxicity-of-kava-piper-methysticum-as-a-case-of-ill-defined-herbal-drug-identity-lacking-quality-control-and-misguided-regulatory-politics
BfArM (2003) Warning against use of preparations containing extracts from Piper methysticum (“Kawa-Kawa”). Retrieved from https://www.bfarm.de/SharedDocs/Risikoinformationen/DE/kawa_kawa_warnung_englisch_pdf?__blob=publicationFile&v=2 Gruenwald J., Brendler T., Jaenicke C.(2004) PDR for Herbal Medicines 4th edn.. Montvale: Thomson Healthcare Inc.. pp 545–546 .
Pittler M H & Ernst E.(2005) Systematic review: herbal medicinal products for non-psychiatric disorders BMJ 330(7498):134–137 doi: 10 1038/bmj330 7498 134 PMID 15637863 . Sarris J., Stough C., Bousman C.(2011) Kavaindole derivatives from Piper methysticum show anxiolytic effects without sedative side effects Phytomedicine 18(12):1045–1048 doi: 10 1016 j phymed 2011 01 020 PMID 21796890.
Sarris J & LaPorte E.(2012) Clinical psychopharmacologyofkavapreparations Human Psychopharmacology 27(5):409–416 doi: 10 1002 hup 1251 PMID 22709817
Kava for Generalized Anxiety Disorder: https://pubmed.ncbi.nlm.nih.gov/23635869/
[…] published by the World Health Organization did an in depth dive into the subject. It concluded that kava is safe and the root itself wasn’t the cause of the liver damage being reported. Kava has been around for centuries, and there have been no reports of liver issues […]