Do Not Use! Germans May Ban the Dietary Supplement Drug Kava-Kava

According to a story from Reuters Health News on November 20, 2001, German authorities are considering a ban on the sale of products containing more than tiny amounts of the herb Kava-Kava after reports of 24 cases of liver damage linked to the “drug” in Germany. We verified this report with colleagues who provided us with additional references linking Kava-Kava to liver damage.

Kava-Kava is a pharmacologically active extract from the root of the shrub Piper methysticum. Awa, Intoxicating Pepper, Kawa, Salau, and Tonga are common names for Kava-Kava. The drug has been used for a bewildering array of disorders including epilepsy, psychosis, depression, migraine, colds, tuberculosis, and rheumatism to name a few. It is also used as a ceremonial beverage to induce relaxation in the South Pacific. Kava-Kava is hawked in health food stores in this country and on the internet to relieve stress, anxiety, insomnia, and tension.

Above we referred to Kava-Kava as a drug, rather than a dietary supplement. Congress “changed” plant drugs into foods by calling them dietary supplements in 1994 with the passage of the Dietary Supplement Health and Education Act (DSHEA). However, not even the Congress of the United States can turn drugs into food. Kava-Kava is pharmacologically active, it is promoted as a drug, therefore it is a drug and, more importantly, it is an unregulated drug under DSHEA.

Of the 24 German cases, one person died and three had to have liver transplants. Their diagnoses included liver failure, hepatitis (inflammation of the liver) and cirrhosis (scarring of the liver).

Swiss physicians from the University of Geneva describe what might be a typical case of toxicity from Kava-Kava that resulted in a liver transplant. This case was reported in the January 20, 2001 issue of the British Medical Journal.

A 50-year-old man presented to his physician with jaundice (yellowing of the skin or whites of the eyes). He complained of fatigue for a month, a “tanned” skin, and dark urine (these are signs of liver toxicity). His medical history was normal except for anxiety, for which he had been taking three to four capsules of Kava-Kava extract daily for two months. He took no other drugs and did not consume alcohol.

The blood levels of his liver enzymes had increased 60- and 70-fold above normal values. The rule of thumb is that a threefold increase above the upper limit of normal in these tests is a signal for possible liver toxicity. When he was admitted to the hospital, tests for viral infections that could cause liver damage were negative. His condition deteriorated over the next 48 hours and he received a liver transplant two days later. The patient recovered uneventfully.

Kava-Kava extracts are produced using either ethanol (drinking alcohol) or acetone (at one time a nail polish remover). Our German colleagues inform us that producers using ethanol extracts claim better tolerability for their products than those produced with acetone. This is a typical ploy of dietary drug makers, to claim that one product is safer than another because of its method of extraction, even in the absence of evidence that it is safer. However, the method of preparation of Kava-Kava appears not to have an influence on the drug’s toxicity. The German drug regulatory authorities, the Federal Institute of Drugs and Medical Products, has received an equal number of reports of liver toxicity involving extracts produced with ethanol or acetone.

A Swiss Kava-Kava product produced using acetone was removed from the market in October 2000 because of liver toxicity.

Market withdrawal of Kava-Kava products is not expected before early 2002, because of a requirement for a mandatory hearing under German drug law. U.S. manufacturers of Kava-Kava products need not worry. The Food and Drug Administration (FDA) has no practical authority to require warnings on Kava-Kava products, let alone to easily remove this drug from the market. Kava-Kava will continue to be sold with impunity in the U.S. for the foreseeable future.

What You Can Do

You should avoid Kava-Kava and other dietary supplement drugs. These products possess no known health benefits and may carry unacceptable risks.