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MedWatch: The FDA Safety Information and Adverse Event Reporting Program
Products containing herbal extracts of kava have been implicated in
Europe
in at least 25 cases of serious liver toxicity including hepatitis,
cirrhosis, and liver failure.
FDA is investigating whether the use of dietary supplements containing
kava
(also known as kava kava or Piper methysticum in the United States) poses
similar public health concerns.
Due to the potentially serious nature of these concerns, we are asking that
you review your cases of liver toxicity to determine if any may be related
to the use of kava-containing dietary supplements.
Please report any cases of hepatic toxicity that you think may be related
to the use of kava-containing dietary supplements as soon as possible to
MedWatch by telephone (1-800-332-1088) or through the Internet
(https://www.accessdata.fda.gov/scripts/medwatch/).
To read the complete "Dear Healthcare Professional" letter from The FDA
Center for Food Safety and Applied Nutrition, click on the link below.
http://www.fda.gov/medwatch/safety/2001/safety01.htm#kava
MedWatch is your Internet gateway for timely safety information on drugs
and other medical products regulated by the U.S. Food and Drug
Administration.
Visit the MedWatch web site regularly for the latest
official safety information, at http://www.fda.gov/medwatch
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