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The US Food and Drug Administration (FDA) issued an advisory to consumers about the potential risk of severe liver injury resulting from the use of dietary supplements containing kava. A plant indigenous to the South Pacific, kava (also commonly referred to as kava kava; scientific name Piper methysticum ) has been used for many years in preparing traditional beverages. Recently, supplements containing the herbal ingredient kava have come into wide use for treating stress, anxiety, sleeplessness, menopausal symptoms, and other conditions. Because kava is classified as a dietary supplement, the FDA does not regulate claims made by manufacturers/distributors.
Regulatory agencies in countries including Germany, Switzerland, France, Canada, and the United Kingdom have reacted to reports of liver-related injuries through a variety of actions. In some countries, agencies have warned consumers about the potential risks of kava use, while in other places, products containing kava have been removed from the market. To date, there have been more than 25 reports of serious adverse effects from kava use in other countries, including four patients who required liver transplants.
In the United States, the FDA has received a report of a previously health young woman who required a liver transplant, as well as several reports of liver-related injuries. Potential liver problems associated with products containing kava include hepatitis, cirrhosis, and liver failure. Given the reports to the FDA, persons with liver disease or liver problems and persons who are taking drugs that can affect the liver should contact a physician prior to using kava-containing products. If consumers who use kava products experience symptoms of liver problems, they should immediately consult a doctor. Symptoms of serious liver disease can include nausea, vomiting, light-colored stools, unusual tiredness, weakness, stomach or abdominal pain, and loss of appetite.
The FDA is urging all consumers and their physicians to report any cases of liver injuries or other health problems that may be related to the use of kava products. Adverse effects should be reported as soon as possible, to aid the FDA in collecting all the possible pertinent information. Report problems from the use of dietary supplements by calling the FDA MedWatch program toll free (1-800-332-1088) or through their web site: www.fda.gov/medwatch.