Kava products pose a risk of liver injury

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FDA warns again about Kava

The U.S. Food and Drug Administration has advised consumers that kava

products pose a risk of severe liver injury. Kava (Piper methysticum) is

a plant native to islands in the South Pacific, where it is used to

prepare a traditional beverage. Products containing kava are promoted for

relaxation (e.g., to relieve stress, anxiety, and tension),

sleeplessness, menopausal symptoms and other uses, but the FDA has not

determined whether they are effective. Kava 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 U.S., the FDA has received a

report of a previously healthy young female who required liver

transplantation, as well as several reports of liver-related injuries.

Most cases occurred among people who regularly used high doses or

combined it with alcohol.

The FDA advises kava users who experience signs of illness associated

with liver disease to consult a physician. Symptoms of serious liver

disease include jaundice (yellowing of the skin or whites of the eyes)

and brown urine. Nonspecific symptoms of liver disease can include

nausea, vomiting, light-colored stools, unusual tiredness, weakness,

stomach or abdominal pain, and loss of appetite. [Kava-containing dietary

supplements may be associated with severe liver injury. FDA consumer

advisory, March 25, 2002] http://www.cfsan.fda.gov/~dms/addskava.html

Although herbal products marketed with health claims are really drugs in

disguise, the Dietary Supplement Health and Education Act of 1994

classifies them as dietary supplements. This bill, spearheaded through

Congress by Senators Orrin Hatch and Tom Harkin, was designed to weaken

the FDA's ability to protect consumers from false claims made for herbal

and dietary supplement products. The millions of consumers who have been

economically or physically harmed as a result should consider these two

senators partially responsible for what happened.

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IRA L. JACOBSON

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