Health Canada

Health Canada

September 13, 2010 14:31 ET

Unauthorized Health Product: "E.O.D. Erection on Demand" May Pose Serious Health Risks

OTTAWA, ONTARIO--(Marketwire - Sept. 13, 2010) -

The issue:

Following a consumer complaint regarding the sale of the unauthorized health product, "E.O.D. Erection on Demand" being promoted as a herbal supplement to enhance male sexual performance, the product was tested by Health Canada and found to contain tadalafil. Tadalafil is a prescription medication that may pose serious and potentially life-threatening health risks, particularly to people with heart problems or those at risk of stroke. The product label did not disclose that it contained tadalafil.

Health Canada has not received any reports of adverse reactions in Canada associated with the use of "E.O.D. Erection on Demand". 

Who is affected:

Canadians who have purchased or used "E.O.D. Erection on Demand", particularly people with heart problems or those at risk of stroke.

What consumers should do:

• Consult your healthcare practitioner if you have used this product and are concerned about your health.

• 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 NHPs may have an Exemption Number (EN), which indicates that the product is legally available for sale while Health Canada is in progress of reviewing their application for licensing.

• Report any adverse reaction potentially related to this product to Health Canada (see below).

What Health Canada is doing:

Following a consumer complaint regarding Kaytel Video's (Saint-Laurent, Québec) sale of "E.O.D. Erection on Demand" Health Canada is monitoring their recall of the products from the retail market.

Health Canada is also working with the Canada Border Services Agency to stop future importation of any shipments of "E.O.D. Erection on Demand" from entering Canada. Should Kaytel Video continue to sell this product, Health Canada will take appropriate action.

Consumers may submit complaints regarding the sale of unauthorized health products, or other concerns regarding the safety, efficacy or quality of health products by using the following guideline: How to submit a consumer complaint (GUI-044) ( http://www.hc-sc.gc.ca/dhp-mps/compli-conform/prob-report-rapport/gui_44_consumer_consommateur_cp-pc-eng.php ).

Background:

Tadalafil is used to treat erectile dysfunction and should only be used under the supervision of a health care practitioner. Products authorized for sale containing tadalafil indicate that it should never be used by individuals taking any kind of nitrate drug (e.g. nitroglycerine) as this combination can cause potentially life-threatening low blood pressure.

Individuals with heart problems who take tadalafil are at increased risk of cardiovascular side-effects such as heart attack, sudden cardiac death, stroke, chest pain, high blood pressure and abnormal heart beat. Other side-effects include headache, facial flushing, indigestion, dizziness, visual problems including decrease or loss in vision, and hearing loss. In extremely rare instances, use of tadalafil may potentially result in penile tissue damage and loss of potency.

Canadians taking prescription drugs without being examined and monitored by a health care practitioner may not receive the appropriate treatment to maintain and protect their health. They may also put themselves at risk for drug interactions or harmful side effects.

Products affected:

1. E.O.D. Erection on Demand.

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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 the Canada Vigilance Program of Health Canada toll-free at 1-866-234-2345, or complete a Canada Vigilance Reporting Form ( http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/ar-ei_form-eng.php ) and send to us using one of these methods:

Mail: Canada Vigilance Program
  Marketed Health Products Directorate
  Ottawa, ON, Address Locator 0701C
  K1A 0K9

Related Health Canada Web content:

Send us your feedback: Help improve Health Canada's risk communications by sharing your thoughts on the new format for our Advisories ( http://surveys-sondages.hc-sc.gc.ca/s/adv-temp-mod-avis/langen/ ).

Stay connected with Health Canada and receive the latest advisories and product recalls using these social media tools: http://www.hc-sc.gc.ca/home-accueil/sm-ms/index-eng.php

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Contact Information

  • Media Inquiries:
    Health Canada
    613-957-2983
    or
    Public Inquiries:
    613-957-2991
    1-866-225-0709