Foreign Product Alert

2007-117
September 13, 2007
For immediate release

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

True Man and Energy Max

Date of alert	September 13, 2007
Source of Alert	US Food and Drug Administration (FDA)
Product Names	True Man and Energy Max
Manufacturer / Place of Origin	America True Man Health, Inc., West Covina, California, USA.
Products Description	True Man and Energy Max are marketed as sexual enhancement/erectile dysfunction products. They are sold in capsule form.
Reason for Warning	The US 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

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Media Inquiries:
Alastair Sinclair
Health Canada
(613) 957-1803

These products are not authorized for sale in Canada and have not been found in the Canadian marketplace. However, it is possible these products could be purchased by Canadians travelling abroad or have been brought into Canada through personal importation by travellers or purchased over the Internet.

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

Drugs and natural health products that are authorized for sale in Canada will have 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 any of the products listed in the table 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 these products have been reported in Canada.

To report a suspected adverse reaction, please visit the MedEffect Adverse Reaction Reporting page.