OTTAWA, March 24 /CNW Telbec/ - Health Canada is warning consumers not to
use the unauthorized natural health product XOX For Men, because it contains
an undeclared pharmaceutical ingredient, tadalafil, an ingredient found in the
prescription drug Cialis. The use of XOX For Men 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.
XOX For Men 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 XOX For Men are warned not to use it
and to consult with a medical professional if they have used the product and
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.
XOX For Men is sold in capsule form and contains one blue capsule per
package. There have been no reports of adverse reactions associated with the
use of this product. The product was distributed to a number of retail
outlets, all located in the province of Québec. Health Canada is taking steps
to confirm that the product has been removed from the Canadian market. The
product is also available to order over the Internet.
Health Canada encourages consumers to use only drug products which have
been issued a Drug Identification Number (DIN), or a Natural Product Number
(NPN, or DIN-HM for homeopathic medicines). Before a drug can be sold in
Canada, the manufacturer must first provide Health Canada with scientific
evidence that the drug is safe and effective at meeting its stated claims of
treatment. All authorized drugs sold in Canada carry an eight-digit number,
preceded by the letters DIN, NPN or DIN-HM on the label so consumers can
distinguish between authorized and unauthorized drugs.
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.ca) portal of the Health Canada Web site.
Egalement disponible en français
For further information:
For further information: Media Inquiries: Health Canada, (613) 957-2983;
Public Inquiries: (613) 957-2991, 1-866 225-0709