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Unauthorized Health Product: SX Male Enhancement, May Pose Serious Health Risks
- Starting date:
- July 22, 2010
- Posting date:
- July 22, 2010
- Type of communication:
- Advisory
- Subcategory:
- Natural health products
- Source of recall:
- Health Canada
- Issue:
- Undeclared Substance, Unauthorized products
- Audience:
- General Public
- Identification number:
- RA-110003631
Issue
An unauthorized health product SX Male Enhancement, promoted as a male enhancement herbal supplement, has been found to contain undeclared acetildenafil, a substance similar to the prescription medication, sildenafil, and may pose serious and potentially life-threatening health risks, particularly to people with heart problems. Prescription medications should be taken under the supervision of healthcare practitioners.
SX Male Enhancement was being distributed across Canada by Lockerroom.net Marketing Inc., headquarted in Delta, British Columbia. Health Canada has not received any reports of adverse reactions in Canada associated with the use of SX Male Enhancement.
Who is affected
Canadians who have purchased or used SX Male Enhancement from retail sex stores across Canada or via the distributor's website (www.lockerroom.net), particularly people with heart problems.
What consumers should do
- Consult your healthcare practitioner if you have used this product and are concerned about your health.
- Read the labelling 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 an 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 this product to Health Canada.
What Health Canada is doing
Health Canada is monitoring the distributor, Lockerroom.net Marketing Inc., which has recalled the products from the retail market. Health Canada has been advised by the distributor that it has stopped selling the products.
Health Canada is also working with the Canada Border Services Agency to stop future importation of any shipments of SX Male Enhancement 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.
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: www.healthcanada.gc.ca/medeffect
-
Mail: Canada Vigilance Program
Marketed Health Products Directorate
Ottawa, ON, Address Locator 0701C
K1A 0K9
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