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Fat Burner No. 1 (Qian Mei Yin Zi): Unauthorized Chinese herbal weight loss product may pose serious health risks

Starting date:
December 1, 2010
Posting date:
December 1, 2010
Type of communication:
Advisory
Subcategory:
Natural health products
Source of recall:
Health Canada
Issue:
Product Safety, Undeclared Substance, Product withdrawal
Audience:
General Public
Identification number:
RA-110003990

The issue

Fat Burner No. 1 (labelled in Chinese characters translated as Qian Mei Yin Zi), an unauthorized Chinese herbal weight loss medicine, is being voluntarily recalled by Ying Tai TCM Supplying Ltd. after Health Canada lab tests revealed the product contains two pharmaceutical ingredients that are not declared on the label and that may pose serious health risks: a chemical similar to sibutramine (N,N- didesmethylsibutramine), and sildenafil. Sibutramine is no longer authorized for sale in Canada while sildenafil is a prescription drug and should only be used under the supervision of a healthcare practitioner.

Ying Tai TCM Supplying Ltd. has informed Health Canada that the product was distributed to five stores in Victoria, B.C. and Calgary, Alberta (listed below).

Who is affected

Canadians who have purchased or used Fat Burner No. 1, particularly those with heart problems or at risk of stroke.

What consumers should do

  • Consult your healthcare practitioner if you have used this product and are concerned about your health.
  • Read the label of the 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 Homeopathic Medicine Number (DIN-HM) or a Natural Product Number (NPN) on the label. Some natural health products (NHPs) may have an Exemption Number (EN), which indicates that the product is legally available for sale while Health Canada is reviewing its application for licensing.
  • Report any adverse reaction potentially related to this product to Health Canada (see below).
  • Return any unused product to the place of purchase, or to a pharmacy for safe disposal.

What retailers should do

  • Ying Tai TCM Supplying Ltd. has informed Health Canada that retailers should return any product in stock to the recalling company, Ying Tai TCM Supplying Ltd.

What Health Canada is doing

Health Canada tested product samples after receiving an adverse reaction report involving Fat Burner No. 1.

Ying Tai TCM Supplying Ltd has confirmed to Health Canada that "Fat Burner No. 1" was distributed to five retail locations in Victoria, B.C., and Calgary, AB, as follows:

  1. Dr. Pan's Clinic of TCM, Victoria, B.C.
  2. Double Joy Ltd., Victoria, B.C.
  3. HOC Hyperbaric Care Centre, Victoria, B.C.
  4. Great Wall Health Centre, Calgary AB
  5. Evergreen Acupuncture and Health Services, Calgary AB 

Health Canada is monitoring the recall and is working with the Canada Border Services Agency to stop future shipments of Fat Burner No. 1 from entering Canada. Should Health Canada become aware that this product continues to be sold in Canada, Health Canada will take appropriate action.

Consumers are encouraged to submit complaints regarding the sale of this or any other unapproved health product, or regarding the safety, efficacy or quality of a health product, 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.

Background

Sibutramine was previously used to treat obesity but is no longer authorized for sale in Canada because of its association with an increased risk of cardiovascular side effects such as heart attack and stroke. Those particularly at risk of serious health effects from sibutramine and who should not use this drug include people with heart problems, or who have clinically diagnosed depression or a psychiatric illness. Sibutramine was not recommended for use in women who are pregnant, breastfeeding or planning to become pregnant. Additional side-effects associated with sibutramine include increased blood pressure and heart rate, dry mouth, difficulty sleeping and constipation. N,N- didesmethylsibutramine is a chemical similar to sibutramine and may pose similar health risks. It has not been authorized for sale in Canada.

Sildenafil is a prescription drug used to treat erectile dysfunction and should be taken only under the supervision of a healthcare practitioner. As outlined in the Canadian prescribing information for products containing sildenafil, sildenafil should never be used by individuals taking any kind of nitrate drug (such as nitroglycerine) as it can cause potentially life-threatening low blood pressure. Individuals with heart problems are at increased risk of cardiovascular side-effects such as heart attack, stroke, chest pain, high blood pressure and abnormal heartbeat. Other side-effects include headache, facial flushing, indigestion, dizziness, abnormal vision, and hearing loss.

How to report side effects to health products

To report a suspected adverse reaction to these or other health products, please contact Heath Canada's Canada Vigilance Program toll-free at 1-866-234-2345, or complete a Canada Vigilance Reporting Form and send it 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

 


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