Warning

2006-92
September 19, 2006
For immediate release

Health Canada warns consumers not to use natural sex enhancer Libidus due to potential health risks

OTTAWA - Health Canada is warning consumers not to use the natural health product Libidus because it contains an undeclared pharmaceutical ingredient, a modified form of vardenafil, which is similar to the active pharmaceutical ingredient found in the prescription drug Levitra. The use of Libidus could pose serious health risks, especially for patients with existing medical conditions such as heart problems, those taking heart medications, or those at risk for stroke.

Libidus is advertised as a natural sex enhancer for men and women and is not authorized for sale in Canada. The Canadian importer has been contacted and is recalling the product. Consumers who have purchased Libidus are warned not to use it and to consult with a health professional if they have used the product and have concerns about their health.

Products containing vardenafil should not be used by individuals who are taking any nitrate medication because combining these products could result in the development of potentially life-threatening low blood pressure.

The use of products containing vardenafil has also been associated with serious side-effects which include serious cardiac events such as heart attacks. In rare cases, the use of vardenafil may result in penile tissue damage and permanent loss of potency.

This product is manufactured in Malaysia by Bio-Gulf Sdn Bhd and imported into Canada for distribution by NorthRegentRX, of Winnipeg, Manitoba.

Health Canada also advises Canadians to contact the Health Products and Food Branch Inspectorate at 1-800-267-9675 if they find Libidus for sale in Canada. Health Canada has notified the Canada Border Services Agency to detain any shipment of Libidus detected at the border.

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

To date, no adverse reactions suspected to be associated with the use of this product have been reported to Health Canada. To report a suspected adverse reaction with this or any other health product, please contact the Canadian Adverse Drug Reaction Monitoring Program (CADRMP) of Health Canada by one of the following methods:

Telephone: 1-866-234-2345
Facsimile: 1-866-678-6789

CADRMP
Marketed Health Products Directorate
Tunney’s Pasture, AL 0701C
Ottawa, Ontario K1A 0K9
Email: cadrmp@hc-sc.gc.ca

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Media Inquiries:
Health Canada
(613) 957-2983

Public Inquiries:
(613) 957-2991
1-866 225-0709