Archived – Stamina-Rx

Starting date:

August 19, 2009

Posting date:

August 19, 2009

Type of communication:

Foreign Product Alert (FPA)

Subcategory:

Natural health products

Source of recall:

Health Canada

Issue:

Important Safety Information, Undeclared Substance

Audience:

General Public

Identification number:

RA-12000865

• Media enquiries
• Public enquiries

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.

Source of alert

U.S. Food and Drug Administration (FDA)

Product name

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.

What you should do

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.

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

Background

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.

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.

Report a health or safety concern

• Call toll-free at 1-866-234-2345.
• Visit Health Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

Media enquiries

Health Canada
613-957-2983

Public enquiries

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