Kava (Piper methysticum) is a plant indigenous to the islands in the South Pacific, where it is commonly used to prepare a traditional beverage.
Supplements containing the herbal ingredient kava are promoted for relaxation, sleeplessness, menopausal symptoms, and other uses. The FDA has not made a determination about the ability of kava dietary supplements to provide such benefits.
Liver-related risks associated with the use of kava have prompted regulatory agencies in other countries, including those in Germany, Switzerland, France, Canada, and the United Kingdom, to take action.
Although liver damage appears to be rare, the FDA believes consumers should be informed of this potential risk.
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.
|Over 25 cases of liver-related injuries associated with kava.
Four patients required liver transplants.
In the USA, the FDA has received a report of a previously healthy young female who required liver transplantation, as well as several reports of liver-related injuries.
Given these reports, the FDA advises that people who have liver disease or liver problems, or people who are taking drug products that can affect the liver, should consult 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 their physician, they add.
The FDA will continue to investigate the relationship, if any, between the use of dietary supplements containing kava and liver injury.
The agency's investigation includes attempting to determine a biological explanation for the relationship, and to identify the different sources of kava in the USA and Europe.
The agency will alert consumers, and if warranted, take additional action, as more information becomes available.