Unapproved Health Product, “POWER-MAX” May Pose Serious Health Risks
OTTAWA - Health Canada is warning Canadians that an unapproved health product that contains sildenafil, a prescription medication was found on the Canadian market in Ontario. Sildenafil may pose serious health risks, particularly to people with heart problems. Health Canada is working with the Canada Border Services Agency to stop future importation of any shipments of "POWER-MAX" from entering Canada. "POWER-MAX" was imported by Cha Health Food.
Health Canada has contacted Cha Health Food and has been advised that the product was voluntarily recalled at the retail level. Health Canada is taking steps to confirm that "POWER-MAX" has been removed from the Canadian market. Health Canada is also advising retailers to remove this product from their shelves, and consumers should return the product to the place of purchase. Consumers who have purchased "POWER-MAX" are advised to consult with a medical professional if they have used the product or have concerns about their health.
Sildenafil is used to treat erectile dysfunction and should only be used 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 (e.g. nitroglycerine) as it 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.
Drugs and natural health products that are authorized for sale in Canada will have either an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN) or a Homeopathic Medicine Number (DIN-HM) on the label. These numbers indicate that the products have been assessed by Health Canada for safety, effectiveness and quality.
To date, Health Canada has not received any reports of adverse reactions in Canada associated with the use of this product.
Consumers requiring more information about this advisory can contact Health Canada 's public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.
You can report any adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
- Report online at the MedEffect™ Canada section of the Health Canada website
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and either:
- Fax toll-free to 1-866-678-6789
- Mail to: Canada Vigilance Program
Ottawa , ON K1A 0K9
To have postage pre-paid, download the postage paid label from the MedEffect™ Canada section of the Health Canada website. The Canada Vigilance Reporting Form and the adverse reaction reporting guidelines may also be obtained via this section.
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