POPULAR HERB MAY SEVERELY HARM LIVER

Kava Users Warned After Severe Injuries, Transplants Reported

A Polynesian herbal relaxant popular in trendy drink bars and sold in
health stores across the nation may cause liver damage, the Food and
Drug Administration warned yesterday.

Kava is suspected in more than 25 cases of severe liver damage in
North America and Europe, prompting FDA officials to issue a public
warning urging consumers to consult with doctors before using kava if
they have liver problems or take medications that affect the liver.

While the exact effect of kava on the liver is unknown, people who
have used kava products have suffered liver injury, including
hepatitis, cirrhosis and liver failure, according to the FDA.

In the United States, the FDA is investigating a report of a
previously healthy young female kava user who required a liver
transplant. The agency also reports that four kava users have required
liver transplants, while several others had liver injuries.

"This kind of liver damage appears to be extremely rare. But because
it's severe liver damage, we felt consumers needed to be aware of it,"
FDA supplement chief Dr. Christine Taylor said.

The FDA warns that consumers of kava who experience symptoms of
serious liver disease, including yellowing of the skin or whites of
the eyes and brown urine, should contact their physicians. Other
symptoms can include nausea, vomiting, light-colored stools, unusual
tiredness, weakness, stomach or abdominal pain and loss of appetite.

The FDA is investigating what relationship, if any, exists between the
use of kava products and liver injury. The agency also is trying to
identify the different sources of kava in the United States and Europe.

Kava, long popular in the South Pacific as an antidote to anxiety and
insomnia, is not classified as a drug by the FDA and is considered a
dietary supplement.

Two years ago, San Mateo County unsuccessfully prosecuted two people
for driving under the influence after they'd consumed large amounts of
kava tea.

$50 Million Annual Market

Some in the industry estimate the kava market at about $50 million
annually worldwide. A San Francisco Mission District bar, Twenty-Two
O2, offers herbal elixers, including a drink called "The Moon Swing,"
made with kava. Many local health stores sell kava root powder or kava
extracts as a dietary supplement.

Kava is also widely available on the Web, marketed on one site as
having no adverse side effects while being potentially "very effective
at relieving depression and anxiety, improving mental ability,
relaxing muscles, reducing pain, and lifting the mood by promoting
feelings of well-being and friendship. Kava also promotes deep,
refreshing sleep with no grogginess after waking."

Kava is identified on product labels under a variety of names,
including ava, awa, kawa, Piper methysticum, sakau, tonga, wurzelstock
and yangona.

Germany, Switzerland, France, Canada and the United Kingdom warned
consumers in December and January about the potential risks of kava
use and in some cases removed kava products from the
marketplace.

Despite the FDA warning, Kava distributors said yesterday they still
believe kava can be used safely.

'Everything In Moderation'

"It's that old adage of everything in moderation," said Rob Story, of
Aloha Seed & Herb in Hawaii. Story said kava-related reports of liver
injury only surfaced in the last decade, about the time that dietary
supplement manufacturers began selling kava extracts, which contain
concentrated kavalactones, a fatlike compound that causes the relaxant
affects.

Previously, kava root was generally dried and put in drinks, which
Story believes might be a safer way to ingest it.

Gary Warren, owner of San Francisco's Good Health Natural Foods, said
he still feels comfortable stocking kava on his shelves.

"I do believe it's dosage-related. If you overdo anything, you're
going to have complications," Warren said.

The FDA released some information about the cases it is investigating,
although the locations of the patients were not given.

The patients include two 13-year-olds who were hospitalized after
using kava. In one case, doctors believe the kava interacted with a
dental anesthetic. The other case appeared to be a deliberate overdose.

Other patients included a woman suffering kidney and liver problems
who used more than 20 supplements and other over-the-counter remedies
and a woman who ingested up to 15 kava pills every day in addition to
prescription drugs.

Marketed Without Safety Tests

Unlike pharmaceuticals -- whose manufacturers must run tests to
convince the FDA the drugs are safe -- a 1994 law allows dietary
supplements to go to market without tests for safety. The burden is on
the FDA to prove whether a supplement is unsafe, and then convince its
manufacturers to pull it from the market.

The FDA urges consumers and health care professionals to report any
cases of injuries related to kava use to its MedWatch program by
calling its toll-free number, (800) 332-1088, or by making contact
through the Internet (http: //www.fda.gov/medwatch).