FDA
Probes Link Between
Kava, Liver Damage
Excerpt
By Robert
Preidt, HealthScoutNews
(HealthScoutNews) -- Federal health officials are investigating
whether dietary supplements containing the herb kava may be associated
with liver damage, including hepatitis, cirrhosis and liver failure.
The U.S. Food and Drug Administration (FDA) review follows recent
actions by Canada, Australia and some European nations that warned
people about -- or banned -- over-the-counter supplements that contain
kava.
Those measures came after reports out of Europe of liver damage
caused by kava, a plant from the South Pacific used to treat anxiety
and insomnia.
In December, the FDA sent a letter to U.S. physicians asking
them to report any cases of liver damage they believe may be associated
with kava. An FDA spokesman says that between 1998 and late last
month, the agency received 38 reports of "adverse effects"
believed to be kava-related.
One of those reports involved a young woman who suffered liver
failure and required a liver transplant, says the spokesman, who
would not offer additional details about her case.
The FDA spokesman says 10 of the 38 reports were received after
the letter was sent to health-care professionals in December.
He couldn't say how long the FDA review might continue.
Dietary supplements don't need to be pre-approved by the FDA
for sale to consumers. But the FDA has the authority to "take
action" on a supplement once it's on the market and a problem
becomes apparent, the spokesman says. Those actions could range
from a warning letter to the manufacturer, to fines, to seizure
of the product.
Kava, also known as kava kava, is a member of the pepper family.
South Pacific islanders have used it for thousands of years as
a ceremonial drink. It has become increasingly popular in the
United States in recent years as a treatment for anxiety and insomnia.
Kava ranks ninth in sales of all herbal dietary supplements
sold in U.S. mainstream retail markets, with sales of about $15
million in 2000, according to the American Botanical Council,
a nonprofit herbal research and education organization.
The council says those sales figures don't include kava sold
in health-food stores, by mail order or by health professionals,
and that could amount to another $15 million or more.
"Our position is that more research and investigation needs
to be undertaken because there's clearly some questions about
the adverse events that were reported" in Europe, says Wayne
Silverman, chief administrative officer of the council.
He adds there's no proof kava is harmful, but the council suggests
users adhere to these recommendations:
- Don't take kava if you have any liver problems, drink alcohol
regularly, or are taking a drug that has known adverse effects
on the liver.
- Don't take kava on a daily basis for more than four weeks
because adverse reports so far seem to be associated with chronic
use.
- Stop using kava is you notice any signs of jaundice, such
as dark urine or yellowing of the eyes.
- If you have a history of liver problems, consult your doctor
before taking kava.
Those same guidelines are being put forward by the association
that represents American growers, processors, manufacturers and
marketers of herbs and herbal products.
Michael McGuffin, president of the American Herbal Products
Association, says his group is taking a "hyper-cautious"
approach in response to the reports out of Europe, and wants to
ensure that consumers are well-informed about kava.
The association released an advisory in January informing consumers
of the overseas reports that suggest a link between kava and liver
damage. The advisory also mentioned the FDA review of kava.
The association is reviewing possible revisions to consumer
instructions and cautions on the labels of kava products, McGuffin
says.
In addition, the association hired a toxicologist to review
available kava case reports from Europe and the United States.
The report, completed last month and submitted to the FDA, found
no conclusive evidence of a link between kava and liver damage,
McGuffin says.
What To Do: You can learn more about kava from the American
Botanical Council or Quackwatch.
Reference
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