2008-46
March 20, 2008
For immediate release
OTTAWA - Health Canada is warning consumers not to use Libidus, an unauthorized product promoted on the web site of the manufacturer for the treatment of erectile dysfunction. The product may pose serious health risks, as it was found to contain the undeclared prescription drug sildenafil, which should only be used under the supervision of a health care professional. Patients with pre-existing medical conditions, including those with heart problems, those taking heart medications, or those at risk for strokes, may be at an increased risk of serious health effects associated with the use of this product.
Use of sildenafil by patients with heart disease can result in serious cardiovascular side-effects such as sudden cardiac death, heart attack, stroke, low blood pressure, chest pain and abnormal heartbeat. Additionally, use of sildenafil may be associated with other side-effects including vision loss, seizure, sudden decrease or loss of hearing, dizziness, prolonged erection, headache, flushing, nasal congestion, indigestion and abdominal pain. Sildenafil should not be used by individuals taking any type of nitrate drug (e.g., nitroglycerin) due to the risk of developing potentially life-threatening low blood pressure.
Libidus is labelled as manufactured by Yurtland Natural Health, and distributed by NorthRegentRX, of Winnipeg, Manitoba. Health Canada has requested and is monitoring the distributor's recall of Libidus. The product may be available at retail outlets across Canada, and over the Internet. Health Canada issued a Warning in 2006 for the product Libidus, which, at the time, was found to be adulterated with the prescription drug vardenafil, and was manufactured by a company in Malaysia.
Health Canada advises retailers to remove Libidus from their shelves, and consumers should return the product to the place of purchase. Health Canada is taking steps to confirm that the product has been removed from the Canadian market. Canadians who have used Libidus and are concerned about their health should consult with a health care professional.
Health Canada advises consumers not to use Libidus or any other unauthorized products promoted for the treatment of erectile dysfunction that are advertised as "all natural", as such products may contain undeclared prescription ingredients that may pose serious risks to health. Consumers who are concerned about erectile dysfunction should consult with their health care professional to discuss appropriate and authorized treatments.
Drugs and natural health products that are authorized for sale in Canada have an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN) or a Drug Identification Number for Homeopathic Medicine (DIN-HM) on the label.
Consumers requiring more information about this advisory can contact Health Canada's public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.
To report a suspected adverse reaction to this health product, please contact the Canada Vigilance Program of Health Canada by one of the following methods:
Telephone: 1-866-234-2345
Facsimile: 1-866-678-6789
Canada Vigilance Program
Marketed Health Products Directorate
Ottawa, Ontario, AL 0701C
K1A 0K9
E-mail: CanadaVigilance@hc-sc.gc.ca
The Canada Vigilance adverse reaction reporting form, including a version that can be completed and submitted online, is located in the Med Effect area of the Health Canada Web site.
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Media Inquiries:
Health Canada
(613) 957-2983
Public Inquiries:
(613) 957-2991
1-866 225-0709
