Kava Kava Knocked By FDA
Kava kava has been much advertised as a sedative, muscle relaxant and diuretic and, in recent years, has become very popular. It is sold without a prescription. Some while ago MedicineNet carried a couple of stories about the dangers of kava kava. One story was titled Kava Kava - Herb Hurts Liver. The other was called
Rhubarb - Over Kava Kava Alert.
To my mind, medicinal herbs such as kava kava should be regulated by the FDA just like prescription drugs in the US. It is impossible for anyone to remember all the different health warnings about different herbs. Why not have the FDA protect us from adverse herb effects?
For additional information, please see the following MedicineNet.com
areas:
Frederick
Hecht, MD, FAAP
Associate Chief Medical Editor, MedicineNet.com
KAVA-CONTAINING DIETARY SUPPLEMENTS MAY BE ASSOCIATED WITH SEVERE LIVER
INJURY
March 27, 2002 - The Food and Drug Administration (FDA) is advising consumers of the potential
risk of severe liver injury associated with the use of kava-containing dietary
supplements. Kava (Piper methysticum) is a plant indigenous to the islands in
the South Pacific where it is commonly used to prepare a traditional beverage.
Supplements containing the herbal ingredient kava are promoted for relaxation
(e.g., to relieve stress, anxiety, and tension), sleeplessness, menopausal
symptoms and other uses. FDA has not made a determination about the ability of
kava dietary supplements to provide such benefits.
Liver-related risks associated with the use of kava have prompted regulatory
agencies in other countries, including those in Germany, Switzerland, France,
Canada, and the United Kingdom, to take action ranging from warning consumers
about the potential risks of kava use to removing kava-containing products from
the marketplace. Although liver damage appears to be rare, FDA believes
consumers should be informed of this potential risk.
Kava-containing 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., FDA has received a report of a previously healthy young female who
required liver transplantation, 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.
Consumers who use a kava-containing dietary supplement and who experience
signs of illness associated with liver disease should also consult their
physician. 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.
FDA urges consumers and their health care professionals to report any cases
of liver and other injuries that may be related to the use of kava-containing
dietary supplements. Adverse events associated with the use of dietary
supplements should be reported as soon as possible to FDA's MedWatch program by
calling their toll-free number (1-800-332-1088) or through the Internet (http://www.fda.gov/medwatch).
The presence of kava in a supplement should be identified on the product
label in the "Supplement Facts" box. The following are commonly used
names for kava:
- ava
- ava pepper
- awa
- intoxicating pepper
- kava
- kava kava
- kava pepper
- kava root
- kava-kava
- kawa
- kawa kawa
- kawa-kawa
- kew
- Piper methysticum
- Piper methysticum Forst.f.
- Piper methysticum G. Forst.
- rauschpfeffer
- sakau
- tonga
- wurzelstock
- yangona
FDA will continue to investigate the relationship, if any, between the use of
dietary supplements containing kava and liver injury. The agency's investigation
includes attempting to determine a biological explanation for the relationship
and to identify the different sources of kava in the U.S. and Europe. The agency
will alert consumers, and if warranted, take additional action as more
information becomes available.
(Source: http://www.cfsan.fda.gov/)
Last Editorial Review: 3/27/2002
Medication RSS