Health Canada, Aug 21, 2002
2002-38
August 21, 2002
Advisory
Health Canada issues a stop-sale order for all products containing Kava
OTTAWA - Health Canada is issuing a stop-sale
order for all products containing the herb kava after a safety
assessment concluded there is insufficient evidence to support their
safe use. The department is also requesting the recall of these
products from all levels of the market.
Kava is found in herbal and homeopathic preparations and may also
be occasionally found in food. It has been reported to be used as a
treatment for anxiety, nervousness, insomnia, pain and muscle
tension.
Health Canada and several foreign regulatory agencies have
received reports associating the use of kava with serious liver
dysfunction. Based on currently available information, the use of
kava-containing products is considered to pose an unacceptable
potential risk to health. Health Canada is therefore requiring
Canadian manufacturers, distributors and importers to stop the sale
of kava-containing products, and is requesting that these products
be recalled from all levels of the market. Health Canada is working
to identify all importers, manufacturers and distributors of
kava-containing products to monitor the removal of these products.
Health Canada will also issue a customs alert to prevent further
shipments of these products from entering Canada.
This advisory follows a Health Canada advisory issued January 16,
2002, announcing the department’s intention to conduct a safety
assessment as a result of worldwide reports of liver toxicity
associated with the herbal ingredient kava. In light of this
assessment, Health Canada now considers products containing kava to
be drugs and has determined there are no acceptable food uses for
kava. This recall applies to all products containing kava in Canada.
There have been four cases of liver toxicity associated with the use
of kava-containing products reported in Canada. None of the Canadian
cases have resulted in death. Other foreign regulatory authorities
(including Germany, Switzerland, the United Kingdom and the United
States) have also received several reports of liver toxicity
associated with the use of kava, among which there were three
fatalities. Based on the currently available information, it is
estimated that individuals who may be at particular risk of liver
toxicity associated with kava use include those who have compromised
liver function due to pre-existing liver problems related to
disease, age factors, or prior or current drug/alcohol abuse.
In addition to liver toxicity, kava use has also been associated
with side effects that include an itchy scaly skin condition (known
as kava dermopathy), muscle weakness and coordination problems.
Consumers are advised to check the label of any herbal or food
products for the presence of kava, (see table below for list of
names by which kava may be identified). Consumers are also advised
to discontinue use of these products and return them to their point
of sale. Consumers are reminded to consult with their health care
practitioner if they have experienced any adverse effects from
taking products containing kava. The following symptoms may be
associated with liver problems:
- jaundice (yellowing of the skin or whites of the eyes);
- brown urine;
- nausea;
- vomiting;
- unusual tiredness;
- weakness;
- stomach or abdominal pain; and /or
- loss of appetite.
Health Canada asks that health care professionals and
practitioners of complementary and alternative medicine continue to
report any suspected adverse effects, including liver toxicity,
associated with the use of kava-containing products to Health Canada.
This advisory has been distributed to all known importers,
manufacturers and distributors of kava-containing products, the
Canadian Medical Association, the Canadian Pharmacists Association,
the Canadian Naturopathic Association, the Canadian Coalition of
Herbal Associations, the Canadian Chiropractic Association, the
Canadian Coalition of Homeopathic Medicine, the Canadian Health Food
Association, Provincial and Territorial Ministries of Health, and
other relevant associations.
Health Canada will continue to assess kava’s safety, and will
review and evaluate new scientific information as it becomes
available by means of an expert advisory panel, which is in the
process of being created.
Check labels carefully. Kava may be identified by the
following names:
- kava
- kava kava
- kava-kava
- kava root
- kava-kava root
- kavain
- kava pepper
- kavapipar
- kawa
- kawa kawa
- kawa pepper
- kawapfeffer
- maori kava
- rhizoma di kava-kava
|
- ava
- ava pepper
- ava root
- awa
- gea
- gi
- intoxicating pepper
- intoxicating long pepper
- kao
- Piper methysticum
- Macropiper Latifolium
- Piper inebrians
|
- Malohu
- maluk
- meruk
- milik
- kew
- Rauschpfeffer
- sakau
- tonga
- Wurzelstock
- yagona
- yangona
- yaqona
- yongona
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The text in this article was prepared by Health Canada.