Warning

2007-27
March 24, 2007
For immediate release

Health Canada warns Canadians not to use the sexual enhancer XOX For Men, due to potential health risks

OTTAWA – 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 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:
Health Canada
(613) 957-2983

Public Inquiries:
(613) 957-2991
1-866 225-0709