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Unauthorized Health Product, SeXXX DRIVE, May Pose Serious Health Risks
- Starting date:
- August 18, 2010
- Posting date:
- August 18, 2010
- Type of communication:
- Advisory
- Subcategory:
- Natural health products
- Source of recall:
- Health Canada
- Issue:
- Undeclared Substance, Product Safety
- Audience:
- General Public
- Identification number:
- RA-110003692
The issue
An unauthorized health product, SeXXX DRIVE, promoted as a herbal supplement to enhance male sexual performance, was tested by Health Canada and found to contain undeclared "hydroxyhomosildenafil, a substance similar to the prescription medication sildenafil. Sildenafil may pose serious and potentially life-threatening health risks, particularly to people with heart problems. Prescription medications should be taken only under the supervision of healthcare practitioners.
Who is affected
Canadians, particularly people with heart problems, who have purchased or used SeXXX DRIVE from retail sex stores across Canada or online at www.lockerroom.net, www.iterotics.com, or www.fantasyfactory.ca.
What consumers should do
- Consult your healthcare practitioner if you have used this product and are concerned about your health.
- Read the label of the products you buy to verify that they have been assessed by Health Canada for safety, effectiveness and quality. Health products that have been authorized for sale by Health Canada will have a single eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN) or a Homeopathic Medicine Number (DIN-HM) on the label.
- Report any adverse reaction potentially related to these products to Health Canada (see below).
What Health Canada is doing
SeXXX DRIVE was being sold across Canada by Lockerroom.net Marketing Inc, AJP Enterprises and Coast to Coast Video Sales. Health Canada is taking steps to confirm that SeXXX DRIVE will be removed from the Canadian market.
Should any of these companies continue to sell unauthorized health products that may pose a risk to the health and safety of Canadians, Health Canada will take immediate and appropriate action. Health Canada has not received any reports of adverse reactions associated with the use of SeXXX DRIVE.
Health Canada is working with the Canada Border Services Agency to stop the importation of any shipments of SeXXX DRIVE from entering Canada.
Background
Sildenafil is used to treat erectile dysfunction and should be used only under the supervision of a health care practitioner. Products authorized for sale containing sildenafil indicate that it should never be used by individuals taking any kind of nitrate drug (such as nitroglycerine), as this combination can cause potentially life-threatening low blood pressure.
Individuals with heart problems are at increased risk of cardiovascular side-effects such as heart attack, stroke, chest pain, high blood pressure and abnormal heart beat. Other side-effects include headache, facial flushing, indigestion, dizziness, abnormal vision, and hearing loss.
Products affected
- SeXXX DRIVE
For more information
Consumers and health professionals wanting more information about this advisory from Health Canada can contact the Public Enquiries Line at 613-957-2991, or toll free at 1-866-225-0709.
Media enquiries related to this Advisory should be directed to Health Canada Media Relations at 613-957-2983.
How to report side effects to health products
To report a suspected adverse reaction to these or other health products, please contact the Canada Vigilance Program of Health Canada toll-free at 1-866-234-2345, or complete a Canada Vigilance Reporting Form and send it to us using one of these methods:
- Fax: 1-866-678-6789
- E-mail: CanadaVigilance@hc-sc.gc.ca
- Internet: MedEffect Canada
-
Mail: Canada Vigilance Program
Marketed Health Products Directorate
Ottawa, ON, Address Locator 0701C
K1A 0K9
Related Health Canada Web Content
- Advisory (July 22, 2010) – Unauthorized Health Product: "SX Male Enhancement" May Pose Serious Health Risks
- Advisory (July 13, 2010) – Unapproved Health Product "Up Ultimate Performance For Men" May Pose Serious Health Risks
- Advisory (March 8, 2010) – Unapproved Health Product, "Power-Max" May Pose Serious Health Risks
- Advisory (January 8, 2010) – Canadians Advised Not to use "Stiff Nights" or Any Unauthorized Product Promoted for Erectile Dysfunction
- Warning (November 25, 2009) – Health Canada Warns Consumers Not to Use "Once More" or Any Unauthorized Product Promoted to Enhance Male Sexual Performance
Related AWRs
"Lightning Rod": A New Potentially Dangerous IT Erotics' Product Removed from Sale
2012-07-06 | Health products
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