Stamina-Rx

Foreign Product Alert
2009-134
August 19, 2009
For immediate release

Health Canada is advising consumers not to use the following products specified below due to concerns about possible side-effects. More info

Source of Alert: U.S. Food and Drug Administration (FDA)
Product Names: Stamina-Rx
Manufacturer / Place of Origin: Hi-Tech Pharmaceuticals, Inc., Norcross, Georgia, U.S.A.

Product Description
Stamina-Rx is promoted as a dietary supplement used for male sexual enhancement.

It is sold in 10-, 30- and 40-tablet bottles, and in 2- and 6-tablet blister packs.

Reason for Warning
The FDA informed consumers of a voluntary recall of Stamina-Rx by the manufacturer after FDA tests found the product contained the undeclared pharmaceutical substance benzamidenafil.

Benzamidenafil is a new, unauthorized substance with chemical properties similar to prescription drugs used to treat erectile dysfunction, and likely poses similar health risks.

Possible Side-Effects
Benzamidenafil belongs to a class of drugs used to treat erectile dysfunction. These drugs 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 are at increased risk of cardiovascular side-effects such as heart attack, stroke, chest pain, high blood pressure and abnormal heart beat. Other side-effects include headache, facial flushing, indigestion, dizziness, abnormal vision, and hearing loss.

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Media Enquiries:
Health Canada
(613) 957-2983

For more details on these Foreign Product Alerts, please visit the Health Canada Web site.

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These products are not authorized for sale in Canada and have not been found in the Canadian marketplace, but it is possible they may have been brought into the country by travellers or purchased over the Internet.

Canadians who have this product are advised not to use it, and should consult with a health care professional if they have concerns about their health related to the use of this product.

Drugs and natural health products that are authorized for sale in Canada will have either an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN) or a Homeopathic Medicine Number (DIN-HM) on the label. These numbers indicate that the products have been assessed by Health Canada for safety, effectiveness and quality.

Health Canada advises Canadians to contact the Health Products and Food Branch Inspectorate at 1-800-267-9675 if they find the products listed above in the Canadian marketplace.

For more information about the information contained in this advisory, please contact Health Canada's public inquiries line at (613) 957-2991 or toll-free at 1-866-225-0709.

As of the date of this posting, no adverse reactions suspected to be associated with the use of this product have been reported in Canada.