Foreign Product Alert: King-Wolf Tablets, MAGNA-RX Capsules, My Steel Woody, Black Storm tablets, 4L Slimness and 4L Slimburn Plus, Dream Body 450mg, Dream Body Advanced 400mg, Dream Body Advanced + Acai Weight Loss & Cleanse, Dream Body Original For...

Starting date:

August 24, 2016

Type of communication:

Foreign Product Alert (FPA)

Subcategory:

Natural health products

Source of recall:

Health Canada

Identification number:

RA-59928

• 
  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.

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 Health Products

Product Name(s)	Hazard(s) Identified	Source of Alert	Images
Unauthorized Sexual Enhancement Products
King-Wolf Tablets	Undeclared sildenafil	Australian Therapeutic Goods Administration
MAGNA-RX Capsules	Undeclared sildenafil and paracetamol (acetaminophen)	Australian Therapeutic Goods Administration
My Steel Woody	Undeclared sildenafil	United States Food and Drug Administration
Black Storm tablets	Undeclared sildenafil and vardenafil	Australian Therapeutic Goods Administration
Unauthorized Weight Loss Products
4L Slimness and 4L Slimburn Plus	Undeclared diclofenac	Hong Kong Department of Health
Dream Body 450mg	Undeclared sibutramine	United States Food and Drug Administration
Dream Body Advanced 400mg	Undeclared sibutramine	United States Food and Drug Administration	No picture
Dream Body Advanced + Acai Weight Loss & Cleanse	Undeclared sibutramine, fluoxetine, and sildenafil	United States Food and Drug Administration
Dream Body Original Formula	Undeclared sibutramine	United States Food and Drug Administration
Dream Body Extreme Gold	Undeclared sibutramine, fluoxetine, and sildenafil	United States Food and Drug Administration
SBF Bee Pollen	Undeclared sibutramine	United States Food and Drug Administration
Extra Slim Plus Acai Berry Weight Loss Formula	Undeclared sibutramine	United States Food and Drug Administration
Lose Weight Coffee	Undeclared sibutramine	Hong Kong Department of Health
Other Unauthorized Products
TANGKE TEGONGYIHAOJIAONANG	Undeclared phenformin and glibenclamide	Hong Kong Department of Health

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 with 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 a Homeopathic Drug Number (DIN-HM).

Background

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

Acetaminophen (also known as paracetamol) is an ingredient used in both non-prescription and prescription drugs to treat fever and pain. Long-term use of high doses of acetaminophen may cause serious liver damage.

Diclofenac is a prescription drug in the family known as non-steroidal anti-inflammatory drugs (NSAIDs) and is used to treat pain, fever and inflammation. Side effects include changes in blood pressure, gastrointestinal disorders (with or without bleeding), anemia, kidney failure and reduced blood clotting ability.

Fluoxetine is a prescription drug used to treat depression.  Side effects include headache, sleeping problems, anxiety, nausea, loss of appetite and excessive sweating.

Glibenclamide (also known as glyburide) is a prescription drug used to treat diabetes. Side effects include severe low blood sugar which may cause sweating, paleness, chills, headache, dizziness and confusion.

Phenformin was previously used to treat type 2 diabetes but is no longer authorized in Canada because of its association with a life-threatening risk of lactic acidosis, an often fatal metabolic disorder in which an abnormal amount of lactic acid accumulates in the blood. Other side effects include low blood sugar which may cause sweating, paleness, chills, headache, dizziness and confusion.

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.

Vardenafil is a prescription drug used to treat erectile dysfunction.  Vardenafil  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 August 22, 2016, two adverse reactions suspected to be associated with the use of products named “MAGNA-RX Plus” and “Lose Weight Coffee” have been reported to Health Canada.  Because of limited information, it is unknown if these reports involve the same products as those described in the foreign alerts.

Images

Select thumbnail to enlarge - opens in a new window