Warning
2007-32
March 29, 2007
For immediate release
OTTAWA -- Health Canada is warning consumers not to use the unauthorized product Vigorect Oral Gel Shooter, because it contains an undeclared drug substance tadalafil, which should only be available by prescription. The use of Vigorect Oral Gel Shooter could pose serious health risks, especially for patients with existing medical conditions such as heart problems, those taking heart medication, or those at risk of stroke.
Products containing tadalafil 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 tadalafil has been associated with serious side effects including serious cardiac events such as heart attacks, sudden cardiac death, angina, irregular heart rate, or stroke. In extremely rare instances, use of tadalafil may potentially result in penile tissue damage and permanent loss of potency.
Vigorect Oral Gel Shooter is advertised as a natural sex enhancer and is not authorized for sale in Canada. The Canadian importer has been contacted and is recalling the product. Consumers who have purchased Vigorect Oral Gel Shooter are warned not to use it and to consult with a medical professional if they have used the product or have concerns about their health.
Products containing tadalafil should be available only with a prescription written by a medical practitioner licensed in Canada. The use of such a product may require a physical check-up, individualized directions for use, and on-going monitoring by a physician.
Vigorect is sold in packets of liquid gel. There have been no reports of adverse reactions associated with the use of this product. The product is available at retail outlets and is also sold over the Internet. Health Canada is taking steps to confirm that the product has been removed from the Canadian market.
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.
Consumers requiring more information about this warning 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 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
email: cadrmp@hc-sc.gc.ca
The CADRMP adverse reaction reporting form, including a version that can be completed and submitted online, is located on the MedEffect portal of the Health Canada Web site.
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Media Inquiries:
Alastair Sinclair
Health Canada
(613) 957-1803
Public Inquiries:
(613) 957-2991
1-866 225-0709
