OTTAWA, March 29 /CNW Telbec/ - 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
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
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:
Marketed Health Products Directorate
Tunney's Pasture, AL 0701C
The CADRMP adverse reaction reporting form, including a version that can
be completed and submitted online, is located on the MedEffect
(www.medeffect.gc.ca) portal of the Health Canada Web site.
Egalement disponible en français
For further information:
For further information: Media Inquiries: Alastair Sinclair, Health
Canada, (613) 957-1803; Public Inquiries: (613) 957-2991, 1-866 225-0709