Health Products that May Pose a Serious Risk to Health Removed From Vancouver Island Stores

Starting date:

November 4, 2010

Posting date:

November 4, 2010

Type of communication:

Advisory

Subcategory:

Drugs, Natural health products

Source of recall:

Health Canada

Issue:

Product Safety

Audience:

General Public

Identification number:

RA-110003911

• 
  Reason
• 
  What you should do
• 
  Who is affected
• 
  Background
• 
  Report health or safety concerns
• 
  What Health Canada is doing

Unauthorized health products that may pose serious risks to health were removed by Health Canada from two Fitness Etc. stores on Vancouver Island, British Columbia: one in Campbell River and one in Courtenay.

Reason

The labels on some of these products indicate they contain ingredients that legally require the products to be sold by prescription because they are used to treat serious diseases or may have side effects that require monitoring by a health care practitioner.

What you should do

• Consult your healthcare practitioner if you have used any of these products and are concerned about your health.
• Read the label of all products you buy to verify that they have been assessed by Health Canada for safety, effectiveness and quality. Health products that have been authorized for sale by Health 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. Some natural health products may have an Exemption Number (EN), which indicates that the product is legally available for sale while Health Canada is in the process of reviewing their application for licensing.
• Report any adverse reaction potentially related to these products to Health Canada (see below).

Who is affected

Canadians who have purchased any of the products listed below that were sold at Fitness Etc. in Campbell River, and at Fitness Etc. in Courtenay, British Columbia, particularly people with heart problems, pregnant women, some cancer patients, and people with high blood pressure or diabetes.

Background

Canadians who have taken unauthorized prescription products without the supervision of a healthcare practitioner or without a prescription may face additional risks. You may be misdiagnosed, the treatment might not be appropriate to treat your illness and you may miss the opportunity to obtain appropriate medical treatment. You may also put yourself at risk for drug interactions, or harmful side effects.

A number of these products pose specific risks to the health and safety of Canadians. Ephedrine and caffeine, when combined together, may cause serious and possibly fatal adverse effects. Several health advisories have been issued by Health Canada warning Canadians not to use products containing ephedrine/ephedra, in combination with caffeine and other stimulants, for purposes of weight loss, body building or increased energy (further information available below under "Related Health Canada Web content").

Some of the unauthorized health products also indicate "M1T" or "DHEA" on the label. 17-Methyl-1 androstene-17b-ol-3one, also known as M1T, and dehydroepiandrosterone, also known as DHEA, are sex hormones that are regulated as controlled drugs in Canada that require a valid prescription from a practitioner to be dispensed by a pharmacist.

Since these sex hormones have potential side effects, including fetal effects if taken during early pregnancy, disruption of ovulation leading to infertility in women and production of spermatozoids in men, promotion of the development of several types of cancer (including prostate, breast, endometrium), serious cardiovascular complications (stroke, heart attack, thrombophlebitis, pulmonary embolism) and liver toxicity, it is important that these drugs be prescribed and supervised by a health care professional, to ensure appropriate treatment and monitoring for side effects for each individual patient.

Specific drug ingredients may be subject to additional restrictions as outlined in the Food and Drugs Act and the Controlled Drugs and Substances Act.

Report health or safety concerns

To report suspected adverse reaction to these or other health products, please contact the Canada Vigilance Program of Health Canada toll-free at 1-866-234-2345, or complete a Canada Vigilance Reporting Form and send to us using one of these methods:

• Fax: 1-866-678-6789
• E-mail: CanadaVigilance@hc-sc.gc.ca
• Internet: www.healthcanada.gc.ca/medeffect
• Mail: Canada Vigilance Program
  
  Marketed Health Products Directorate
  
  Ottawa, ON, Address Locator 0701C
  
  K1A 0K9

What Health Canada is doing

Following seizure of these unauthorized products being offered for sale at these Vancouver Island stores, Health Canada is working with the Canada Border Services Agency to help stop the importation of these unauthorized health products into Canada. Health Canada has also been advised by the store owners that these unauthorized products will no longer be sold at Fitness Etc. in Campbell River, and at Fitness Etc. in Courtenay, British Columbia.

Consumers may submit complaints regarding the sale of unapproved health products, or regarding the safety, efficacy or quality of health products by calling Health Canada's Inspectorate, toll-free, at 1-800-267-9675. For more information, see the guidance document "How to submit a consumer complaint (GUI-044)" available on the Health Canada website.