Foreign Product Alert: ABX Weight Loss, Accelerator Boost, Ready Man!, Results, Skinny Bee Diet, Side Head Regulator TT Tablet, Supreme Slim 5.7, Ultimate Body Tox, Zi Su Body Fat Health II

Starting date:

January 13, 2017

Type of communication:

Foreign Product Alert (FPA)

Subcategory:

Natural health products

Source of recall:

Health Canada

Issue:

Important Safety Information, Unauthorized products

Audience:

General Public

Identification number:

RA-61792

• Issue
• What you should do
• Background
• Report health or safety concerns
• Images

Issue

These foreign health products have been found by regulators in other countries to contain undeclared drug ingredients or heavy metals (lead).

The products are not authorized for sale in Canada and have not been found in the Canadian marketplace, but it is possible they may have been brought into the country by travellers or purchased over the Internet.

Unauthorized Foreign Health Products

Product Name(s)	Hazard(s) Identified	Source of Alert	Images
Unauthorized Sexual Enhancement Products
Ready Man!	Undeclared sildenafil	United States Food and Drug Administration
Unauthorized Weight Loss Products
ABX Weight Loss	Undeclared sibutramine	United States Food and Drug Administration
Accelerator Boost	Undeclared phenolphthalein	United States Food and Drug Administration
Results	Undeclared sibutramine and phenolphthalein	United States Food and Drug Administration
Skinny Bee Diet	Undeclared desmethylsibutramine, sibutramine, and phenolphthalein	United States Food and Drug Administration
Supreme Slim 5.7	Undeclared phenolphthalein and sildenafil	United States Food and Drug Administration
Ultimate Body Tox	Undeclared sibutramine	United States Food and Drug Administration
Zi Su Body Fat Health II	Undeclared sibutramine and phenolphthalein	United States Food and Drug Administration
Other Unauthorized Products
Side Head Regulator TT Tablet	High levels of lead	United States Food and Drug Administration

What you should do

• Contact Health Canada at 1-800-267-9675 or by completing an online complaint form if you find a product listed above in the Canadian marketplace.
• Consult a healthcare professional if you have health concerns related to the use of any of these products.
• 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), Natural Product Number (NPN) or Homeopathic Drug Number (DIN-HM).

Background

Prescription drugs should only be used under the supervision of a healthcare professional.

Desmethylsibutramine is an unauthorized substance similar to sibutramine, a prescription drug previously used to treat obesity, and may pose similar health risks. Sibutramine 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. Other side effects include increased blood pressure and heart rate, dry mouth, difficulty sleeping and constipation.

Lead is a heavy metal that poses serious health risks. Ingestion of excessive amounts of lead may accumulate in vital organs of the body. Children are most susceptible to the toxic effects of heavy metals. The toxic effects of lead include abdominal pain, anemia, changes in blood pressure, reproductive disorders such as miscarriage, weakness, concentration problems, weight loss, insomnia, dizziness, and kidney and brain damage.

Phenolphthalein was previously used as a laxative but is no longer authorized for sale in Canada because it may cause cancer. Additional side effects include decreased blood pressure, skin rash and gastrointestinal bleeding.

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. Other side effects include increased blood pressure and heart rate, dry mouth, difficulty sleeping and constipation.

Sildenafil is a prescription drug used to treat erectile dysfunction. Sildenafil should not be used by individuals taking any kind of nitrate drug (e.g., 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.

Report health or safety concerns

To report a side effect to a health product to Health Canada:

• Call toll-free at 1-866-234-2345
• Visit Health Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax

As of January 11, 2017, no adverse reactions suspected to be associated with the use of these products have been reported to Health Canada.

Images

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