Advisory - Unauthorized "Libigrow" Found on the Québec Market

OTTAWA, March 15, 2013 /CNW/ -

The issue:

An unauthorized natural health product, "Libigrow" was tested by Health Canada and found to contain hidden ingredients (sildenafil and tadalafil) that may pose serious risks to the health of Canadians. "Libigrow" was being sold at two retail locations in the province of Québec: Boutique Sexie folie Inc. (Sainte-Catherine) and at Boutique Érotique 5ième avenue Inc. (Valleyfield).

This product is promoted as a male sexual stimulant and contains hidden prescription medications. Approved drugs that contain these medications can only be sold with a prescription and by a pharmacy. The purchase of such products elsewhere can put your health at serious risk.

Who is affected:
Canadians who have purchased or used these products, particularly people with heart problems.

What consumers should do:

• Consult your healthcare practitioner with any questions or concerns regarding use of "Libigrow".
• 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).
  
• Report any adverse reaction potentially related to "Libigrow" or other health products to Health Canada.
• Contact Health Canada's toll-free line at 1-800-267-9675 with questions or complaints about "Libigrow" or other health products.

What Health Canada is doing:

Boutique Sexie folie Inc. consented to forfeit its supply of "Libigrow" to Health Canada inspectors. "Libigrow" was sold at Boutique Érotique 5ième Avenue until December 2012. Health Canada is also working with the Canada Border Services Agency to stop any further shipments of "Libigrow" from entering Canada. The product's manufacturer, as identified on the label, is H&K Nutraceuticals, located in Los Angeles.

Background:

Sildenafil and tadalafil are prescription medications that should only be used under the supervision of a health care practitioner. Products containing sildenafil or tadalafil should never be used by individuals taking any kind of nitrate drug (e.g. nitroglycerine) as they 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 or tadalafil to help them achieve an erection. Other possible side-effects of using sildenafil or tadalafil include headache, facial flushing, indigestion, dizziness, abnormal vision and hearing loss.

Products affected:

1.Libigrow - http://files.newswire.ca/1043/Products_affected.pdf

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 to health products:

To report suspected adverse reaction to these or other health products, please contact Health Canada's Canada Vigilance Program toll-free at 1-866-234-2345, or complete a Canada Vigilance Reporting Form and send to us using one of these methods:

• Fax: [phone]
• Internet: www.healthcanada.gc.ca/medeffect
• Mail: Canada Vigilance Program
  Marketed Health Products Directorate
  Ottawa, ON, Address Locator 0701E
  K1A 0K9

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Également disponible en français

PDF available at: http://stream1.newswire.ca/media/2013/03/15/20130315_C5449_DOC_EN_24588.pdf

SOURCE: Health Canada

For further information:

Media Enquiries: 
Health Canada
[phone]

Public Enquiries:
[phone]
1-866 225-0709