Archived - Health Canada warns consumers not to use Zencore Tabs due to potential health risks

Starting date:

July 20, 2007

Posting date:

July 20, 2007

Type of communication:

Advisory

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Undeclared Substance

Audience:

General Public

Identification number:

RA-110002133

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  Media enquiries
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Health Canada is warning consumers not to use Zencore Tabs, a product advertised as a dietary supplement for sexual enhancement, because it contains an undeclared pharmaceutical ingredient similar to the approved drug tadalafil. Tadalafil is a prescription medication indicated for the treatment of erectile dysfunction and should only be used under the supervision of a health professional. The use of Zencore Tabs 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.

Zencore Tabs is not authorized for sale in Canada and the Canadian importer has been contacted and is recalling the product. Consumers who have purchased Zencore Tabs are warned not to use the product and to consult with a medical professional if they have used it or have concerns about their health.

Zencore Tabs is sold in blister packages of two pink-purple capsules. There have been no reports of adverse reactions associated with the use of this product. Health Canada is taking steps to confirm that the product has been removed from the Canadian market. The product was available at retail outlets and may also be sold over the Internet.

More information about purchasing drugs over the Internet, and other warnings on similar products, is available on the Health Canada Web site.

To report a suspected adverse reaction to this 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

Ottawa, ON, AL 0701C

K1A 0K9

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 area of the Health Canada Web site.

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