Kava and severe liver injury

FDA Consumer, May-June, 2002

Recent reports indicate a potential risk of severe liver injury associated with the use of kava-containing dietary supplements. Kava (Piper methysticum) is a plant native to the islands of the South Pacific, where it is commonly used to prepare a traditional beverage. Supplements containing the herbal ingredient kava are promoted for relaxation (to relieve stress, anxiety and tension), sleeplessness, menopausal symptoms, and other uses. The FDA has not made a determination about the ability of kava dietary supplements to provide such benefits.

Although liver damage appears to be rare, kava-containing products have been associated with liver-related injuries--including hepatitis, cirrhosis, and liver failure--in over 25 reports of adverse events in other countries. Four people required liver transplants. In the United States, the FDA has received a report of a previously healthy young female who required a liver transplant, as well as several reports of liver-related injuries.

People who have liver disease or liver problems, or people who are taking drug products that can affect the liver, should talk to a physician before using kava-containing supplements.

Consumers who use a kava-containing dietary supplement and who experience signs of illness associated with liver disease should also consult a physician. Symptoms of serious liver disease include jaundice (yellowing of the skin or whites of the eyes) and brown urine. Other symptoms of liver disease can include nausea, vomiting, light-colored stools, unusual tiredness, weakness, stomach or abdominal pain, and loss of appetite.

The FDA urges consumers and health-care professionals to report any adverse events associated with the use of kava-containing products or other dietary supplements to the FDA's MedWatch program by calling its toll-free number (1-800-332-1088) or through the Internet (www.fda.gov/ medwatch/how.htm).

The presence of kava in a supplement should be identified on the product label in the "Supplement Facts" box.

The FDA will continue to investigate the relationship, if any, between the use of dietary supplements containing kava and liver injury. The agency will alert consumers, and if warranted, take additional action as more information becomes available. For more information on dietary supplements, see www.cfsan.fda.gov/ ~dms/supplmnt.html.

Commonly Used Names For Kava

* ava

* ava pepper

* awa

* intoxicating pepper

* kava

* kava pepper

* kava root

* kava-kava

* kawa

* kawa-kawa

* kew

* Piper methysticum

* Piper methysticum Forst.f.

* Piper methysticum G. Forst.

* rauschpfeffer

* sakau

* tonga

* wurzelstock

* yangona