OTTAWA, Nov. 7, 2014 /CNW/ -
The issue:
An unauthorized health product, Gra-MaxX Gold, was seized by Health Canada as it contains an undeclared drug: N-Ethyl Tadalafil. The product is used to treat erectile dysfunction. The product was tested by Health Canada and removed from sale from ShopForYou, Robson Street, Vancouver, B.C. This product may pose serious risks to the health of Canadians, especially individuals with heart problems.
Who is affected:
Consumers who have used or purchased Gra-MaxX Gold.
What consumers should do:
- Consult with your doctor if you have used this product.
- 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 an eight-digit Drug Identification Number (DIN), a Homeopathic Medicine Number (DIN-HM) or a Natural Product Number (NPN) on the label.
- Report any adverse events to Health Canada.
What Health Canada is doing:
Health Canada has seized the product from ShopForYou.
Background:
Tadalafil should only be used under the supervision of a health care practitioner. Products containing tadalafil or its analogs 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 including high blood pressure, a history of heart attack, stroke, abnormal heart beat or chest pain are at higher risk of cardiovascular side-effects if they engage in sexual activity, especially if they use tadalafil to help them achieve an erection. Other possible side-effects of using tadalafil include headache, facial flushing, indigestion, dizziness, abnormal vision and hearing loss.
Caffeine was also found in the product and was not listed on the product label. Caffeine may pose health risks to people sensitive to its effects.
Products recalled/affected:
Gra-MaxX Gold.
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 problems with consumer products (or) How to report side effects to health products to Health Canada:
- Call toll-free at 1-866-234-2345
- Visit MedEffect Canada's web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.
Stay connected with Health Canada and receive the latest advisories and product recalls using social media tools.
PDF available at: http://stream1.newswire.ca/media/2014/11/07/20141107_C5538_PDF_EN_7703.pdf
SOURCE: Health Canada
Media Enquiries: Health Canada, (613) 957-2983; Public Enquiries: (613) 957-2991, 1-866 225-0709; Également disponible en français
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