27 unauthorized sex enhancement and weight loss products

Starting date:

October 19, 2016

Type of communication:

Foreign Product Alert (FPA)

Subcategory:

Drugs, Natural health products

Source of recall:

Health Canada

Issue:

Unauthorized products, Undeclared Substance, Important Safety Information

Identification number:

RA-60628

• Issue
• What you should do
• 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
Anaconda Strong Formula	Undeclared sildenafil	United States Food and Drug Administration
Ant Power tablets	Undeclared sildenafil	Australian Therapeutic Goods Administration
Boss-Rhino Gold X-tra Strength	Undeclared sildenafil	United States Food and Drug Administration
De Guo Hei Bei (徳国黑倍)	Undeclared sildenafil	United States Food and Drug Administration
Golden Ant tablets	Undeclared sildenafil and chloramphenicol	Australian Therapeutic Goods Administration
Libigirl	Undeclared sildenafil	United States Food and Drug Administration
Man King capsules	Undeclared sildenafil	Australian Therapeutic Goods Administration
Power Spring (XXX) Oral Liquid	Undeclared sildenafil	United States Food and Drug Administration
Shangai Ultra X	Undeclared sildenafil	United States Food and Drug Administration
Super Shangai	Undeclared sildenafil	United States Food and Drug Administration
The Golden Root	Undeclared sildenafil	United States Food and Drug Administration
Weili (一炮到天亮 or Yi Pao Dao Tian Liang)	Undeclared sildenafil	United States Food and Drug Administration
Ziyinzhuangyang	Undeclared sildenafil	United States Food and Drug Administration
Unauthorized Weight Loss Products
Adelganzantes R-II	Undeclared sibutramine	United States Food and Drug Administration
B-finn	Undeclared orlistat and 2-(diphenylmethyl) pyrrolidine (desoxy-D2PM)	Hong Kong Department of Health
Citrus’ Fit	Undeclared sibutramine and desmethylsibutramine	United States Food and Drug Administration
Double S	Undeclared sibutramine	Hong Kong Department of Health
Mang Luk Power Slim	Undeclared sibutramine	United States Food and Drug Administration
Mang Luk Power Slim Detox	Undeclared sibutramine and desmethylsibutramine	United States Food and Drug Administration
Maxx Easy	Undeclared sibutramine and lorcaserin, and orlistat	United States Food and Drug Administration
Mi Show Slimming capsules	Undeclared sibutramine	Australian Therapeutic Goods Administration
Slim Fit X	Undeclared sibutramine and desmethylsibutramine	United States Food and Drug Administration
Ultimate Lean	Undeclared sibutramine and desmethylsibutramine	United States Food and Drug Administration
Xcelerated Weight Loss Charged Up	Undeclared sibutramine	United States Food and Drug Administration
Xcelerated Weight Loss Turbo Charge	Undeclared sibutramine	United States Food and Drug Administration
Xcelerated Weight Loss Ultra Max	Undeclared phenolphthalein and sildenafil	United States Food and Drug Administration
Zi Xiu Tang Beauty Face and Figure Capsule	Undeclared phenolphthalein and fluoxetine	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.

Chloramphenicol is a prescription antibiotic drug. Side effects include abdominal pain, allergic reactions, and bone marrow failure (aplastic anemia).

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.

Desoxy-D2PM is an unauthorised psychoactive, stimulant substance. Side effects include hallucinations, violent behaviour, dilated pupils, fast heart rate, and high blood pressure.

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

Lorcaserin is a prescription weight-loss drug that is not authorised for sale in Canada. Side effects include fatigue, headache, cough, sore throat, breathing difficulties, nausea, abdominal discomfort, back pain, irregular heartbeat, leg swelling, anxiety, mood change and depression. In diabetic patients, severe low blood sugar may occur.

Orlistat is a prescription weight-loss drug. Side effects include abdominal discomfort, anal leakage, increased stool volume and frequency, and fatty/oily stool.

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 October 14, 2016, no adverse reactions suspected to be associated with the use of these products have been reported to Health Canada.

Images

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