Health Canada, Dec 23, 2003
2003-103
December 23, 2003
Advisory
Health Canada reminds Canadians not to use products containing
kava
OTTAWA - Health Canada is reminding consumers of the
serious risks associated with the use of products containing kava. An
independent market survey revealed that many retail outlets still sell
products containing kava, despite Health Canada's recall and advisory
regarding these products in August 2002.
In light of market survey findings, Health Canada has issued another
letter to industry, pharmacists and retail outlets, to remind them of the
recall and stop sale order that are still in effect.
Kava is found in a range of herbal and homeopathic preparations and may
also be occasionally found in food. It is reportedly used 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. Therefore, the use of kava products
is considered to pose an unacceptable risk to health.
As a result of its safety assessment of the herbal ingredient kava,
which concluded there is insufficient evidence to support its safe use,
Health Canada issued a stop-sale order in August 2002 for all products
containing kava. The department also requested the recall of these
products from all levels of the market and issued an advisory to
consumers, advising against the use of products containing kava. To
prevent further serious adverse reactions in Canada, Health Canada is
asking consumers who find kava products on the shelves to report their
findings to the Health Products and Food Branch Inspectorate by calling,
toll-free, 1-800-267-9675.
There have been four cases of liver toxicity associated with the use of
kava products reported in Canada. None of the Canadian cases resulted in
death. Other foreign regulatory authorities have also received reports of
liver toxicity associated with the use of kava, among which there were
three fatalities. Individuals who have compromised liver function due to
pre-existing liver problems related to disease, age, or prior or current
drug/alcohol abuse may be at particular risk of liver toxicity associated
with kava use.
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. Consumers are also advised to discontinue use of these
products and return them to their point of sale.
Consumers are also 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.
This advisory has been distributed to all known importers,
manufacturers and distributors of kava 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 a scientific expert advisory panel created for this purpose.
The text in this article was prepared by Health Canada.