The Food and Drug Administration
(FDA) is advising consumers of the potential risk of severe liver
injury associated with the use of kava-containing dietary supplements.
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 (e.g., to relieve stress, anxiety,
and tension), sleeplessness, menopausal symptoms and other uses.
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 ranging from warning consumers
about the potential risks of kava use to removing kava-containing
products from the marketplace. Although liver damage appears
to be rare, 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. Four patients required liver transplants.
In the U.S., 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, persons who have liver disease
or liver problems, or persons 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. Symptoms of serious liver
disease include jaundice (yellowing of the skin or whites of
the eyes) and brown urine. Non-specific symptoms of liver disease
can include nausea, vomiting, light-colored stools, unusual
tiredness, weakness, stomach or abdominal pain, and loss of
appetite.
FDA urges consumers and their health care professionals
to report any cases of liver and other injuries that may be
related to the use of kava-containing dietary supplements.
Adverse events associated with the use of dietary supplements
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 (http://www.fda.gov/medwatch).
The presence of kava in a supplement should be
identified on the product label in the "Supplement Facts" box.
The following are commonly used names for kava:
- ava
- ava pepper
- awa
- intoxicating pepper
- kava
- kava kava
- kava pepper
|
- kava root
- kava-kava
- kawa
- kawa kawa
- kawa-kawa
- kew
- Piper methysticum
|
- Piper methysticum Forst.f.
- Piper methysticum G. Forst.
- rauschpfeffer
- sakau
- tonga
- wurzelstock
- yangona
|
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 U.S. and
Europe. The agency will alert consumers, and if warranted,
take additional action as more information becomes available.
This document was issued on March
25, 2002. |
