SYS-CON MEDIA Authors: Doug Masi, Mat Mathews, PR.com Newswire, David Smith, Tim Crawford

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Products Containing Undeclared Prescription Drugs Removed from Burnaby West Box Store

OTTAWA, ONTARIO -- (Marketwired) -- 02/03/14 -- The issue:

Health Canada has removed unauthorized natural health products (see table below) containing various prescription drugs that should only be used under medical supervision, from the retail store, West Box in Burnaby B.C. These products may pose serious risks to the health of Canadians.

Health Canada has not received any adverse reactions reports associated with the use of these products.

Who is affected:

Canadians who either have used or purchased these products. These unauthorized health products were either being promoted for weight loss or for certain eye problems.

What consumers should do:

- 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.

- Report any adverse events using these products to Health Canada.

- Speak to your healthcare practitioner with any questions or concerns regarding these products.

What Health Canada is doing:

Through compliance verification activities, Health Canada identified that West Box (Unit 1337-4500 Kingsway, Crystal Mall) in Burnaby, B.C., was selling these unauthorized products, which were either being promoted for weight loss or for certain eye problems.

The prescription ingredients contained in the various "Crane" products were identified through testing at a Departmental lab.

List of Products


---------------------------------------------------------------------------
Product Name       Prescription       Indicated Use      Date Added
                   Ingredient(s)
---------------------------------------------------------------------------
Crane Beauty Green Sibutramine and    Weight Loss        February 3, 2014
Algae Compound     sildenafil analog
Tablets
---------------------------------------------------------------------------
Crane Beauty Green Fluoxetine         Weight Loss        February 3, 2014
Algae Body
Slimming
Combination
---------------------------------------------------------------------------
Crane Beauty Green Fluoxetine         Weight Loss        February 3, 2014
Algae Complex
Tablets
---------------------------------------------------------------------------
Crane Beauty Green Nicotine           Weight Loss        February 3, 2014
Algae Perfect
Match
---------------------------------------------------------------------------
Sante FX Neo       Neostigmine        Eye drops for      February 3, 2014
                   methylsulfate      tired and red eyes
---------------------------------------------------------------------------
Sante FX V+        Neostigmine        Eye drops for      February 3, 2014
                   methylsulfate      tired and red eyes
---------------------------------------------------------------------------

Background:

Products containing sildenafil should never 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 including high blood pressure, a history of heart attack, stroke, abnormal heart beat or chest pain are at higher risk of cardiovascular side effects if they engage in sexual activity, including if they use sildenafil. Other possible side-effects of using sildenafil include headache, facial flushing, indigestion, dizziness, abnormal vision and hearing loss.

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. In addition to heart attack and stroke, side-effects associated with sibutramine include increased blood pressure and heart rate, dry mouth, difficulty sleeping and constipation.

Fluoxetine is used to treat depression, bulimia nervosa, or obsessive compulsive disorder. Fluoxetine should never be used in combination with certain antidepressants or antipsychotic drugs, as this may lead to fatal side-effects. Fluoxetine may lead to changes in behavior and feelings, including thoughts about suicide and hurting others, changes in heart rhythms or birth defects and may cause allergic reactions.

Neostigmine methylsulfate is usually given as an injection by healthcare professionals to prevent and treat bladder and intestinal problems associated with surgery, to treat myasthenia gravis (a neuromuscular disease characterized by varying degrees of weakness), and to reverse the effect of certain anaesthetics. Neostigmine, when given by injection, has been associated with bradycardia (slow heart beat) and should therefore be administered with other drugs that would counteract this side-effect. It should be used only carefully in patients with coronary artery disease, or other heart problems.

Nicotine should not be used by pregnant women. Symptoms of a nicotine overdose include nausea, abdominal pain, vomiting, diarrhea, cold sweat, dizziness, disturbed hearing and vision, mental confusion, rapid heartbeat, difficulty breathing and marked weakness.

For more information:

Consumers and health professionals wanting more information about this advisory from Health Canada can contact the Public Enquiries Line at 613-957-2991, or toll free at 1-866-225-0709.

Media enquiries related to this Advisory should be directed to Health Canada Media Relations at 613-957-2983.

How to report side effects of health products to Health Canada:

. Call toll-free at 1-866-234-2345

. Visit MedEffect Canada's web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

Stay connected with Health Canada and receive the latest advisories and product recalls using social media tools.

Egalement disponible en francais

Photos of the products are available at the following address: http://media3.marketwire.com/docs/925608pa.pdf

Contacts:
Media Inquiries:
Health Canada
613-957-2983

Public Inquiries:
613-957-2991
1-866-225-0709

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