U.S. Consumers Finally Get Warned About Liver Toxicity with the Dietary Supplement Kava-Kava

On March 25, 2002, the Food and Drug Administration (FDA) finally issued a consumer alert about the possibility of liver toxicity with the dietary supplement drug kava kava. This action came four months after German authorities issued a similar warning to their citizens. Between the time Germans were warned and the FDA advisory, drug regulatory authorities in Switzerland, France, Canada, and the United Kingdom took actions ranging from warning consumers about the potential risks of kava-kava to banning the drug. Switzerland banned the drug outright.

In the January 2002 issue of Worst Pills, Best Pills News we warned that kava-kava should not be used.

Kava-kava is a plant indigenous to islands in the South Pacific where it is used to prepare a traditional ceremonial beverage. The islanders apparently do not drink it chronically. Unregulated dietary supplements containing kava-kava are promoted in this country for relaxation (to relieve stress, anxiety, and tension), sleeplessness, and menopausal symptoms.

Products containing kava-kava have been associated with 25 reports of liver-related toxicity in various countries, including reports of hepatitis, cirrhosis, and liver failure. Four patients required liver transplants. In the U.S., the FDA has received a report of a previously healthy young woman who required liver transplantation, as well as several other reports of liver-related toxicity.

The symptoms of serious liver toxicity include jaundice (yellowing of the skin or whites of the eyes) and brown urine. The non-specific symptoms of liver toxicity can include nausea, vomiting, light-colored stools, unusual tiredness, weakness, stomach or abdominal pain, and loss of appetite. Consumers using dietary supplements containing kava-kava who experience signs of liver toxicity should stop using the product and contact their physician immediately.

The box below gives the commonly used names for kava-kava that should appear on the label of such products. Of course, there is no guarantee that kava-kava products, or any other dietary supplements, are labeled accurately because this industry was deregulated in the U.S. with passage of the Dietary Supplement Health and Education Act (DSHEA) of 1994.

What You Can Do

BUYER BEWARE! You should not take dietary supplements. These products have not been tested or shown to be effective for any use, and their safety is unknown. The only exception to this advice is an inexpensive vitamin or mineral preparation.

Adverse events associated with the use of dietary supplements or other drugs should be reported as soon as possible to FDA’s MedWatch program by calling their toll-free number (1-800-332-1088) or through the Internet (www.fda.gov/medwatch).