FDA on Kava:
FDA Issues Warning on Kava-Containing Supplements
Tue Mar 26,10:34 AM ET
WASHINGTON (Reuters Health) - Following in the footsteps of Australia,
Canada and several European nations, the US Food and Drug Administration
(news - web sites) (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 a statement.
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 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," 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 physician."
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 damage.
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 be established.
"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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