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:
rhizoma di kava-kava
intoxicating long pepper
Frequently asked questions: Kava and Liver Toxicity August, 2002
Kava and Liver Toxicity: Frequently Asked Questions
1. What is Kava and what is it used for?
Kava, also known as kava-kava, is a herb derived from a plant native to the South Pacific islands where it has traditionally been used in certain cultures for hundreds of years. It is taken for its mood-enhancing and intoxicating effects, both for ceremonial and recreational purposes. In Canada, kava is found in herbal and homeopathic preparations, which are traditional medicines that contain minute amounts of plants and/or minerals, and may also be occasionally found in food. It has been reported to be used for anxiety, nervousness, insomnia, pain and muscle tension. Health Canada considers products containing kava to be drugs; there are no acceptable food uses for kava.
2. Why is Health Canada requesting a recall?
As part of its safety assessment of kava, Health Canada reviewed the information currently available and determined that, at this time, the department does not have sufficient evidence to support the safe use of kava-containing products. For example, there is insufficient evidence to determine:
a safe dosage below which liver toxicity is not likely to occur; the way in which kava products are broken down by the body;
populations at risk of kava-associated liver problems.
Additionally, on the basis of several reports associating the use of kava with serious liver dysfunction, the use of kava-containing products is considered to pose an unacceptable potential risk to health.
Four cases of liver toxicity associated with the use of kava-containing products were reported in Canada. None of the Canadian cases have resulted in death. The German regulatory authority (BfArM)received 39 spontaneous reports of liver injury associated with the use of kava-containing products, and of these there were three fatalities1.
The United Kingdom reported 3 cases of liver toxicity suspected to be due to kava consumption2. Other foreign regulatory agencies (Switzerland, United States) have also received reports of liver toxicity associated with the use of kava. On the basis of these reports associating kava use with serious liver dysfunction, the use of kava-containing products is considered to pose an unacceptable potential risk to health. Health Canada is therefore requiring a stop-sale and requesting a recall of all kava-containing products until there is satisfactory evidence to support kava's safety.
3. What actions is Health Canada undertaking to protect Canadians?
Health Canada issued a public advisory in January 2002 as a precautionary measure advising consumers not to use any products containing kava until a safety assessment had been conducted. Health Canada has reviewed the information currently available on the herb kava and has determined that, at this time, there is no sufficient evidence to support the safe use of kava-containing products.
As a precaution, Health Canada is requiring a stop-sale of all kava-containing products and is requesting that all manufacturers and importers recall all kava-containing products from all levels of distribution(DIN and non-DIN).
Furthermore, Health Canada is adding kava to Section 1.5 of the Therapeutic Products Compliance Guide (TPCG) due to its unacceptable potential risk to health. As a result, no kava-containing products, with or without a Drug Identification Number (DIN), will be permitted on the Canadian market at this time.
4. How is Health Canada going to ensure that products containing kava come off store shelves?
Health Canada has contacted all known Drug Identification Number (DIN) holders of kava-containing products and is currently identifying the manufacturers, importers and distributors of all kava-containing drug products that do not hold a DIN to facilitate their removal from the market. The department has issued a letter to the above mentioned manufacturers importers and distributors to inform them of the recall and requesting that they remove these products from sale.
Health Canada issued a letter to several associations (e.g. Canadian Pharmacists Association, Canadian Healthcare Association, etc.), to inform them of the recall.
Health Canada will also issue a Customs Alert to prevent further shipments of these products from entering Canada.
To ensure compliance with section C.01.051 of the Food and Drugs Regulations, manufacturers of all kava-containing products have been instructed to notify the Health Products and Food Branch Inspectorate Operational Centre nearest to them within five calendar days of commencing the recall of their product(s) as well as provide written confirmation of completion of the recall process.
Health Canada will monitor this stop-sale and recall; further action will be considered based on the results of this monitoring as well as on the findings of the Expert Advisory Panel.
5. How will the Expert Advisory Panel be formed and who will participate?
The Expert Advisory Panel (E.A.P) is in the process of being formed. This panel will be comprised of individuals outside of Health Canada with expertise in toxicology, liver diseases, pharmacoepidemiology, complementary and alternative medicine. There will also be a mechanism for industry and consumer groups to present information to the E.A.P. The E.A.P. will allow Health Canada to obtain input from external stakeholders in the continuing safety assessment of kava.
6. Other countries, like Germany, have not included homeopathic preparations in their action, why has Health Canada included these products?
While Germany has set a permissible level of kava in homeopathic preparations, to date, there is no scientific evidence to confirm a safe threshold dosage below which liver toxicity is not likely to occur. Therefore, Health Canada cannot establish a safe level of kava at this time. This is why the required stop-sale and the request for recall also applies to these products.
7. What does this stop sale and recall mean for kava food and drinks containing kava?
In light of this assessment, Health Canada considers products containing kava to be drugs and has determined there are no acceptable food uses for kava. Health Canada's recall applies to any kava containing products including all herbal/homeopathic products, foods or beverages such as tea.
8. What are some of the potential adverse reactions that have been associated with kava that are raising concerns?
There are concerns about the possible association between kava-containing products and liver damage. In serious cases, liver damage can result in hospitalization, the need for liver transplantation, or death. To date, there have been 4 reports of kava-associated liver toxicity in Canada. Signs and symptoms of liver damage may include unusual tiredness, weakness, loss of appetite, nausea, vomiting, abdominal pain, itching, jaundice (yellow discolouration of the skin or eyes), dark urine, impaired blood clotting, behavioural changes, and coma.
In addition to liver toxicity, kava use has also been associated with side effects such as an itchy scaly skin condition (known as kava dermopathy), muscle weakness and coordination problems.
9. What should consumers who may have taken or are taking kava herbal products do?
Consumers are advised to check the labels of herbal, homeopathic and food products for the presence of kava, and to discontinue use of any product labeled to contain kava. Consumers are also advised to consult with their health care practitioner if they have experienced any adverse effects from taking kava-containing products. Consumers experiencing any of the signs and symptoms listed above (see previous question), should seek immediate medical advice.
10. How can I identify products that may contain kava?
Health Canada advises the consumer to check food (particularly tea), herbal and drug labels. If the product is labelled to contain kava, then consumers are advised to stop taking it.
11. If a consumer has concerns about products they find on the shelf, who can they contact?
Consumers can direct their questions and complaints to the Health Products and Food Branch Inspectorate Operational Centre closest to them (please see list below).
HEALTH PRODUCTS AND FOOD BRANCH INSPECTORATE OPERATIONAL CENTRES
Atlantic Operational Centre
Suite 1625, 1505 Barrington St.
Halifax, Nova Scotia
Tel: (902) 426-6149
Fax: (902) 426-6676
Manitoba and Saskatchewan Region Operational Centre
510 Lagimodière Blvd.
Tel: (204) 983-1547
Fax: (204) 984-2155
Québec Operational Centre
1001 Ouest, rue St-Laurent
Tel: (450) 646-1353, ext. 232
Tel: (604) 666-3704
Fax: (450) 928-4455
Western Operational Centre
3155 Willington Green
Burnaby, British Columbia
Tel: (604) 666-3704
Fax: (604) 666-3149
Ontario and Nunavut Operational Centre
2301 Midland Avenue
Tel: (416) 973-1466
Fax: (416) 973-1954
1.Federal Institute for Drugs and Medical Devices (BfArM) - BfArM Withdraws Marketing Authorisation for Kava-Kava and Kavain Containing Medicinal Products because of Serious Liver toxicity: Assessment Report, June 14, 2002.
2.Message from Professor A Breckenridge, Chairman, Committee on Safety of Medicines, July 18, 2002, http://www.mca.gov.uk/ourwork/monitorsafequalmed/safetymessages/kavakaa.pdf