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

Starting date:

September 13, 2010

Posting date:

September 13, 2010

Type of communication:

Advisory

Subcategory:

Natural health products

Source of recall:

Health Canada

Issue:

Undeclared Substance, Product Safety

Audience:

General Public

Identification number:

RA-110003747

• What you should do
• Who is affected
• Background
• Affected products
• Report health or safety concerns
• What Health Canada is doing

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.

What you 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 the process of reviewing their application for licensing.
• Report any adverse reaction potentially related to this product to Health Canada (see below).

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.

Background

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

Tadalafil is used to treat erectile dysfunction and should be used only 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 (such as 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.

Affected products

Report health or safety concerns

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 and send it to us using one of these methods:

• Fax: 1-866-678-6789
• E-mail: CanadaVigilance@hc-sc.gc.ca
• Internet: www.healthcanada.gc.ca/medeffect

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

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).