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Archived – Health Canada Advises Consumers Not to Use Life Choice Ephedrine HCL and Life Choice Kava Kava

Starting date:
August 21, 2008
Posting date:
August 21, 2008
Type of communication:
Advisory
Subcategory:
Natural health products
Source of recall:
Health Canada
Issue:
Product Safety, Unauthorized products, Microbial Hazard
Audience:
General Public
Identification number:
RA-110002349

Health Canada is warning consumers not to use the two unauthorized natural health products, Life Choice Ephedrine HCL and Life Choice Kava Kava because they are not approved by Health Canada, and may cause serious adverse health effects including death.

Life Choice Ephedrine HCL 30 mg capsules are packaged in bottles containing 60 capsules, and the label is depicted in the picture shown below. Life Choice Ephedrine HCL contains an excessive amount of ephedrine and when used, alone, or in combination with caffeine or other stimulants for the unauthorized purposes of weight loss, body building, athletic performance or increased energy, may cause serious, potentially fatal adverse health effects. In addition, Health Canada has found this product to be contaminated with bacteria which could cause serious and irreversible adverse health effects, including death. Individuals with a compromised immune system, infants, the elderly, or those with an underlying disease or condition are particularly susceptible.

Consumers should not use Ephedra/ephedrine products other than for the approved indication of nasal decongestion. Use of products containing ephedrine is not recommended in people with heart problems, hypertension, thyroid disease, diabetes, enlarged prostate, anxiety and restlessness, glaucoma (serious eye disorder) and pheochromocytoma (serious gland disorder) because Ephedra/ephedrine aggravates these conditions. These products should also be avoided during pregnancy and lactation.

Life Choice Kava Kava, 150 mg capsules are packaged in bottles containing 60 capsules, and the label is depicted in the picture shown below. Products containing kava have been associated with serious liver dysfunction and, as a result Health Canada has had a stop sale order in effect since August 2002.

Individuals who have compromised liver function related to disease, age, or 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 adverse health effects that include an itchy, scaly skin condition, known as kava dermopathy, muscle weakness, and coordination problems.

Drugs and natural health products that are authorized for sale in Canada will have an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN) or a Homeopathic Medicine Number (DIN-HM) on the label. These numbers indicate that the products have been assessed by Health Canada for safety, effectiveness and quality.

Health Canada advises consumers who are using Life Choice Ephedrine HCL and/or Life Choice Kava Kava to immediately stop doing so and consult their health care practitioner if they are concerned about their health. Consumers who have purchased these products should return them to the place of purchase.

Health Canada is taking measures to prevent these products from entering the Canadian market.

Health Canada also advises Canadians to contact the Health Products and Food Branch Inspectorate at 1-800-267-9675 if they find these Life Choice products for sale in Canada.

Health Canada has previously warned consumers against the use of unauthorized Ephedra/ephedrine-containing products in Canada, in 2005 and 2006, due to the risk of serious adverse effects. Health Canada has also previously warned consumers against the use of kava products in Canada, in 2002 and 2003, due to the risk of serious adverse effects.

To report a suspected adverse reaction to this health product, please contact the Canada Vigilance Program of Health Canada by one of the following methods:

Telephone: 1-866-234-2345
Facsimile: 1-866-678-6789
Canada Vigilance
Marketed Health Products Directorate
Ottawa, Ontario, AL 0701C
K1A 0K9
E-mail: CanadaVigilance@hc-sc.gc.ca

The adverse reaction reporting form, including a version that can be completed and submitted online, is located on the MedEffect portal of the Health Canada Web site.


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