Unauthorized Health Products Sold at Vancouver Sex Show

Starting date:
February 22, 2013
Posting date:
February 22, 2013
Type of communication:
Advisory
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Undeclared Substance
Audience:
General Public
Identification number:
RA-23283

Issue

Two unauthorized health products “18 Again” and “Stiff 4 Hours” were tested by Health Canada and were found to contain hidden ingredients (sildenafil or tadalafil) that may pose serious risks to the health of Canadians. The products were being sold at the Unchained Romance booth at the 12th Annual Vancouver Taboo Sex Show.

These products are promoted as male sexual stimulants and contain hidden prescription medications. Approved drugs that contain them can only be sold with a prescription and by a pharmacy. The purchase of such products elsewhere can put your health at serious risk.

What you should do

  • Consult your healthcare practitioner with any questions or concerns regarding use 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), 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 these products to Health Canada.
  • Contact Health Canada’s toll-free line at 1-800-267-9675 with questions or complaints about these products.

Who is affected

Canadians who have purchased or used these products, particularly people with heart problems.

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.

Report health or safety concerns

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: 1-866-678-6789
  • Internet: MedEffect Canada
  • Mail: Canada Vigilance Program
    Marketed Health Products Directorate
    Ottawa, ON, Address Locator 0701E
    K1A 0K9

Media enquiries

Health Canada
(613) 957-2983

Public enquiries

(613) 957-2991
1-866 225-0709

What Health Canada is doing

Health Canada is testing additional unauthorized products from Unchained Romance and should these products pose similar risks to health, Canadians will be informed. Health Canada is also working with the Canada Border Services Agency to stop any shipments of “18 Again” and “Stiff 4 Hours” from entering Canada.

Images

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