Issues Warning on Kava
WASHINGTON (Reuters Health) - Following in the footsteps of Australia,
Canada and several European nations, the US Food and Drug Administration
(FDA) warned American consumers on Monday against the use of products
containing kava, a herbal ingredient most often promoted for relaxation
and the alleviation of sleeplessness.
The FDA said it was issuing the warning because kava has been associated
with liver-related injuries in the US and several other countries,
including Germany, Switzerland, France, Canada and the United Kingdom.
"Although liver damage appears to be rare, FDA believes consumers
should be informed of this potential risk," the agency said in
According to the FDA, a total of 25 reports were made in the
other nations of liver-related problems such as hepatitis, cirrhosis
and liver failure in people taking kava-containing products. The
FDA said four of those people required liver transplants, following
their liver-related injuries.
In the US, the agency added that it has received at least one
case report that resulted in a liver transplant, involving a previously
healthy young female, as well as several reports of liver-related
"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," according to the federal agency. "Consumers who
use a kava-containing dietary supplement and who experience signs
of illness associated with liver disease should also consult their
According to the FDA, "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."
Kava is an age-old herb from the family of peppers that historically
has been used by islanders in the Pacific to concoct a mildly
narcotic ritual drink.
Other commonly used names for the herbal supplement include
ava, awa and kawa.
The FDA first announced its intention to investigate the potential
link between kava and liver damage in early January. At the time,
the agency said it was aware of about 38 cases of potential liver
Advisors to the German government subsequently recommended that
kava be made a prescription-only product.
In the statement issued on Monday, the FDA said it has not made
any determination with respect to kava's ability to relieve stress,
anxiety, tension or its other promoted uses.
The FDA also said it would continue to investigate the relationship
between Kava and the risk of liver injury, but stopped short of
saying what additional steps the agency might take should a relationship
"The agency will alert consumers, and if warranted, take additional
action as more information becomes available," they said.
FDA officials could not be reached to provide further details.
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