True Man and Energy Max

Starting date:

September 13, 2007

Posting date:

September 13, 2007

Type of communication:

Foreign Product Alert (FPA)

Subcategory:

Natural health products

Source of recall:

Health Canada

Issue:

Undeclared Substance, Unauthorized products, Product Safety

Audience:

General Public

Identification number:

RA-12000144

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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.

Source of alert

U.S. Food and Drug Administration (FDA)

Product name

True Man and Energy Max

Manufacturer / Place of origin

America True Man Health, Inc., West Covina, California, U.S.A.

Product description

True Man and Energy Max are marketed as sexual enhancement/erectile dysfunction products. They are sold in capsule form.

Reason for warning

The U.S. FDA advised consumers not to use Energy Max and True Man after finding the products contained an analogue of sildenafil or vardenafil. All True Man and Energy Max products have been recalled in the U.S.

Sildenafil and vardenafil are prescription medications used for the treatment of erectile dysfunction, and should only be taken under the guidance of a health professional.

Possible side effects

Consumers who use Energy Max or True Man may be at risk of serious side effects similar to those associated with sildenafil and vardenafil, especially those patients with existing medical conditions such as heart problems, those who are taking heart medications, or those who may be at risk for strokes.

Sildenafil and vardenafil are also not recommended for individuals undergoing nitrate drug therapy, because the combination could lead to potentially life-threatening low blood pressure. Other side effects that have been associated with sildenafil and vardenafil include sudden vision loss, seizure and urinary tract infection.

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

Images

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