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FDA
Warns Kava May Be Associated With Severe Liver Injury
Washington DC, 25 March 2002
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 US, FDA has received a report of a previously
healthy young female who required liver transplantation, as well
as several reports of liver-related injuries.
When
to consult physician
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 liver disease
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).
How
to find out if kava is in your supplement
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 US and Europe. The agency will alert consumers, and
if warranted, take additional action as more information becomes
available.
Source
FDA
website, www.cfsan.fda.gov/~dms/addskava.html,
25 March 2002.
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