OTTAWA - Health Canada is warning consumers not to use Vigoureux, an unauthorized product promoted for the treatment of erectile dysfunction. The product may pose serious health risks, as it was found to contain the prescription drug sildenafil, which is not indicated on the label and 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.
Vigoureux is labelled as distributed by International in Montreal, Quebec and labelled in French only. The product may be available at retail outlets across Canada. Health Canada advises retailers to remove Vigoureux from their shelves, and consumers should return the product to the place of purchase. Canadians who have used Vigoureux and are concerned about their health should consult with a health care professional.
Health Canada advises consumers not to use Vigoureux or any other unauthorized products promoted for the treatment of erectile dysfunction that are advertised as Aall natural@, as such products may contain undeclared pharmaceutical 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.
Consumers who have seen this product for sale in Canada should contact Health Canada's Health Products and Food Branch Inspectorate at 1-800-267-9675.
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 MedEffect 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
