Health Canada

Health Canada

March 10, 2008 10:52 ET

Warning: Health Canada Warns Consumers Not to Use ADAM or Any Unauthorized Erectile Dysfunction Products

OTTAWA, ONTARIO--(Marketwire - March 10, 2008) - Health Canada is warning consumers not to use ADAM, an unauthorized product promoted for the treatment of erectile dysfunction, because it may pose serious health risks. ADAM contains an undeclared pharmaceutical ingredient similar to the prescription drug sildenafil which should only be used under the supervision of a health care professional. The product may pose serious health risks, especially for patients with pre-existing medical conditions such as heart problems, those who may be taking heart medications, or those who may be at risk for strokes.

Use of sildenafil by patients with heart disease can result in serious cardiovascular side-effects such as sudden cardiac death, heart attack, stroke, low blood pressure, chest pain and abnormal heartbeat. Additionally, use of sildenafil may be associated with other side-effects including vision loss, seizure, sudden decrease or loss of hearing, dizziness, prolonged erection, headache, flushing, nasal congestion, indigestion and abdominal pain. Sildenafil should not be used by individuals taking any type of nitrate drug (e.g., nitroglycerine) due to the risk of developing potentially life-threatening low blood pressure.

The distributor, Natural Health Solutions, has conducted a voluntary recall of ADAM, that was available at retail outlets across Canada and over the Internet. Health Canada advises retailers to remove this product from their shelves, and consumers should return the product to the place of purchase. Canadians who have used ADAM and are concerned about their health should consult with a health care professional. Health Canada is taking steps to confirm that the product has been removed from the Canadian market.

In addition to ADAM, Health Canada advises consumers not to use any unauthorized erectile dysfunction products, and recommends that consumers talk to a health care professional about authorized treatments for erectile dysfunction. Use of unauthorized products marketed for erectile dysfunction that are advertised as "all natural" may put consumers at risk, as such products may contain undeclared ingredients that should be available only with a prescription.

Drugs and natural health products that are authorized for sale in Canada have an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN) or a Drug Identification Number for Homeopathic Medicine (DIN-HM) on the label.

Consumers requiring more information about this advisory can contact Health Canada's public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.

There has been one report of an adverse reaction associated with the use of the product ADAM. To report a suspected adverse reaction to this health product, please contact the Canada Vigilance Program of Health Canada by one of the following methods:

Telephone: 1-866-234-2345

Facsimile: 1-866-678-6789

Canada Vigilance Program

Marketed Health Products Directorate

Ottawa, Ontario, AL 0701C

K1A 0K9


The Canada Vigilance adverse reaction reporting form, including a version that can be completed and submitted online, is located in the MedEffect ( area of the Health Canada Web site.

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